Quality Assurance:

A Guide t o the Application

of I S 0 9001 t o Process
Plant Projects
Second Edi t i on
Fred Owen and
I
Derek Maidment
(Editors)
Distributed by
GULF PUBLISHING COMPANY
P.O. BOX 2608
Houston, T X 77252-2608 USA
- -
Institution of Chemical Engineers
The information in this guide is given in good faith
and belief in its accuracy, but does not imply the
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Published by
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Copyright O 1996 Institution of Chemical Engineers
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ISBN 0 85295 372 0
Printed in the UK by Henry Ling Limited, The Dorset Press, Dorchester DTI IHD.
ii
Acknowledgements
The first edition of the guide was prsduced in 1992 under the direction of the
Institution of ChemicalEngineers by a Working Party comprised of the following
company representatives:
Dr G.G. Cutts
Mr M.J.P. Garrett
Mr D.W. Maidment
Mr A.T. Markham
Mr F.J. Owen
Dr J.S. Parkinson
Mr A.W.J. Petherbridge
Mr R.P. Willis
Rh6ne-Poulenc Chemicals Ltd
Hawker Siddeley Power Engineering Ltd
The Wellcome Foundation Ltd
Norton Chemical Process Products
Harcros Chemicals UK Ltd
Courtaulds Research Ltd
EEC International Ltd
John Brown Engineers & Constructors Ltd
This revision was prepared by members of the previous Working Party,
namely:
Mr M.J.P. Garrett
Mr D.W. Maidment
Mr F.J. Owen
Mr R.P. Willis
They would also like to thank Mr A. G. Simrnonds of John Brown Engineers &
Constructors Ltd for his contribution on the quality assurance of software.
The Institution expresses its thanks to these members for their individual
contribution.
Foreword t o the first edition
I am happy to recommend the IChemE Guide to the Application of I S 0 9001 to
Process Plant Projects. It is a particular pleasure that the Institution has produced
this and is promoting the ideas of quality assurance and total quality manage-
ment. Inmy 1977Report on Standards and Specifications in the Engineering Industries,
recommendation G was on steps necessary to build a national structure of quality
assurance bodies with mutual acceptance of approvals to avoid multiple assess-
ment. This was taken up in the 1982 White Paper from the Department of Trade
and Industry on Quality Standards and Competitiveness which led to a formal
memorandum of agreement, signed by Lord Cockfield and myself. In 1985 I
presented to the National Economic Development Council the report of a Task
Force on Quality and Standards which carried further the progress on certifica-
tion and its role in removing technical barriers to trade in the EEC.
The Institution is to be congratulated on this guide, which is another of the
substantial aids to industry in the tradition of the pioneer IChemE Model Forms
of Conditions of Contract for Process Plant. It is also part of the whole methodology
which now forms our approach to safety, reliability and economy of resources.
Professor Sir Frederick Warner
Foreword t o the second edition
It is now ten years since Sir Frederick Warner presented the Task Force report to
the NEDC on Quality and Standards. That document laid the corner stone for
the Institution in its pursuance of the principles of quality. During this period
the international Quality Assurance Standard IS0 9001 has increasingly gained
recognition and its principles applied to the management of safety, health and
environmental issues. After its latest 1994 revision it is extremely gratifying to
see the Institution revise its Guide to the Application of I S 0 9001 to Process Plant
Projects. Within the United Kingdom over the last few years we have seen new
stricter laws with respect to safety and the environment. Applying the principles
and concepts within the guide will greatly assist chemical engineers to comply
with this legislation.
Sales of the first edition were extremely encouraging and give a clear indication
of how seriously chemical engineers consider the whole ethos of quality.
In this second edition, the authors have not only updated the guide but have also
addressed the increasing demands, requirements and controls of information
transfer, which is today having a much greater impact on the success of engi-
neering projects.
Personally, one of the most rewarding aspects of this publication is that two of
its contributors were students of mine when I was a young lecturer at the
Borough Polytechnic, London in the early 1960s.
It therefore gives me great pleasure to support and recommend this second
edition of the guide which continues to promote the Institution of Chemical
Engineers in the pursuance of total quality.
Professor John Garside
Contents
Introduction
How to use the guide
1. Scope
2. Normative references
3. Definitions
4. Quality system requirements
4.1 Management responsibility
4.2 Quality system
4.3 Contract review
4.4 Design control
4.5 Document and data control
4.6 Purchasing
4.7 Control of customer-supplied product
4.8 Product identification and traceability
4.9 Process control
4.10 Inspection and testing
4.11 Control of inspection, measuring and test equipment
4.12 Inspection and test status
4.13 Control of nonconforming product
4.14 Corrective and preventive action
4.15 Handling, storage, packaging and delivery
4.16 Control of quality records
4.17 Internal qualify audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
Text references
Page
1
4
5
vii
Introduction
Quality Assurance and Total Quality Management have become recognized as
the modern techniques for improving company competitiveness and profitabil-
ity. In the UK, the initiative for improving the performance of manufacturing
industry was taken by the government in the early 1980s when it launched its
National Quality Campaign. The vehicle used for this campaign by the DTI was
BS5750: 1979: Quality s
y
stems
1
. Emphasis was given to its use by government
departments insisting that their suppliers became registered to this Standard if
they were to continue to receive their business. In the early years most of the
emphasis on its implementation was in the mechanical and electrical component
sectors serving the car industry.
In the mid 1980s chemical manufacturing companies started to receive
demands from customers using products destined for the motor industry to
apply the Quality Assurance system BS 5750: 1979 to their production proce-
dures. These companies found difficulty in interpreting the Standard for chemi-
cal manufacture to such an extent that BSI and the Chemical Industries
Association set up a working party in 1986 to prepare guidance on its consistent
interpretation. This was issued in 1987 as BS 5750: Guidelines for Use by the
Chemical Industry 2. It was published to coincide with the re-issue of the Standard
as BS 5750: 1987 and IS0 9000,1987, to emphasize that theupdated Standard had
received international recognition. This was an important step for the UK to
achieve, given its historically poor reputation for quality. Since that time many
other countries have accepted the Standard. Of particular sighcance was its
recognition in Europe as EN 29000 and the publication b CEFIC in 1991 of EN
Y
29001, ISO9001: Guidelines for Use by the Chemical Industry which superseded the
1987 document previously mentioned.
The 1987 standard, like the 1979 original, was in three parts:
BS 5750: Part 1, IS0 9001, Specification for Design/Development, Production,
Installation and servicing
4
;
BS 5750: Part 2, IS0 9002, Specification for Production and Installation
5
;
BS 5750: Part 3, IS0 9003, Specification for Final Inspection and ~ e s t ~ .
In 1994 the International Standards Organisation published a revision of
IS0 9001 designated:
IS0 9001: 1994, Quality Systems - Model for Quality Assurance in Design,
Development, Production, Installation and ~e r v i c i n ~~.
This has superseded BS 5750: Part 1: 1987 (which has been withdrawn) and
has been recognized in Europe (by CEN, the European Committee for Stand-
ardisation) as EN IS0 9001: 1994. In the UK, the British Standard isnow known
as BS EN IS0 9001: 1994. BSI stated the revision did not include any major
changes, but believed the wording needed to be improved and simplified to
make the Standard more relevant due to its increased application and scale of
usage. Details are given in BSI Quality Assurance Guide to the 1994 Revision of BS
5750, IS0 9000~. The IChemE guide has been revised to take account of the
changes made to IS0 9001: 1987 in the new IS0 9001: 1994.
All references in the guide to IS0 9001 mean IS0 9001: 1994; BS EN IS0
9001 1994 and EN IS0 9001.
The guide sets out to show how IS0 9001 may be applied effectively to a
process plant project from design to commissioning, when it would then be
operated for chemical manufacturing to IS0 9002, for which the most recent
guidance is given by CEFIC as mentioned previously.
In essence, the IS0 9000 series is a formalized quality assurance manage-
ment system designed to ensure that quality is built into every stage of the
activity in hand. It moves away from the concept of quality control by inspection
and test at the end of the project. Implemented successfully, the Standard seeks
to improve performance continuously by learning from experience and exarnin-
ing reasons for complaints, discrepancies and failures and by building corrective
actions into the revised system to avoid their recurrence. In this way costs of
waste, rework, modification, blending and poor plant utilization are reduced
and customers' needs and expectations can be satisfied first time, every time by
constant improvement. An additional benefit, of particular importance to the
process industries, is that such a system strongly reinforces health, safety and
environment standards and procedures, like Hazop, by formally checking,
auditing and improving them on a regular, defined basis. The Institution places
great emphasis on these aspects of all systems relating to project management
and this is reflected throughout this guide.
Because the Standard relates to a quality system and not a product, it can
be applied to any activity, whether researching, designing, manufacturing,
servicing, consulting, building or constructing. Thus, many companies who have
seen the benefits of such a formalized system in manufacturing are applying the
same techniques to every aspect of a company's operation from personnel to
accounts and from telecommunications to marketing. This is a natural progres-
sion to Total Quality Management, TQM. Some large multinationals have started
with a TQM policy and implemented the Standard as a step on the way.
Essentially TQM recognizes that every activity in a company can be regarded as
a 'process' with inputs and outputs which can be given a specification. Equally
important is that each activity or 'process' has a supplier -for example, of design
information - and a customer, both of whose needs and expectations must be
met if the process is to be specified with quality built-in to produce the required
output first time. The same procedures are applied to each process as defined in
the Standard.
Following on from the above, it is believed that the procedures involved
in the design, construction, commissioning and servicing of chemical plant lend
themselves to a Quality Assurance system that has the potential to achieve
substantial savings by reducing costly errors - that is, by building quality into
the design process itself. To this end, in 1989 the IChemE Engineering Practice
Committee (EPC) set up a working party to give guidance on how to implement
IS0 9001 in design offices. The purpose of the guide was to assist companies who
provide such services in interpreting the Standard for all phases of chemical plant
design through to its commissioning, when, hopefully, the company will be
registered to IS0 9002 for chemical manufacture. Many major contracting com-
panies now have registration to IS0 9001. The guidance given here is intended
not only to help both contracting and operating companies in the chemical
process industry, which have their own in-house project design functions, to
achieve the benefits which a formalized Quality Assurance system provides, but
also those in the food, drink, pharmaceutical and building service industries.
There is no doubt that the benefits of Quality Assurance and TQM are real and
the techniques are here to stay. The guide will also prove beneficial to under-
graduates during their design project and to graduates in small to medium sized
companies who have no special or dedicated expertise in Quality Assurance.
It is hoped that this guide will complement the long-standing IChemE
Model Forms of Conditions of Contract for Process Plants Suitable for Lum Sum
It'
Contracfs (the Red ~ o o k ) ~ and Reimbursable Contracts (the Green Book) , thus
advancing the confidence clients have in suppliers who use them.
How to use the guide
The guide has been arranged to enable its user to find the appropriate section
quickly. Whilst some familiarity with the structure and requirements of the
Standard is assumed, it should not be necessary to plough through large portions
of the guide to find the help needed on the topic of the moment. This has led to
unavoidable repetition between some sections. However, ease of use has been
considered to be more important than relying on excessive cross referencing. The
following notes will quickly familiarize the reader with the layout of the guide.
For simplicity, all references are given the IS0 9001 number within Section
4, Quality System Requirements. Each part of Section 4 of the guide has the
corresponding number for the same section in IS0 9001 for direct reference when
needed. Assistance is given under two headings in each part of Section 4 to help
the reader interpret the requirements in relation to process plant projects.
The headings are:
Guidance
This directs the reader into the application of IS0 9001 for a process plant project.
It cannot be specific, but identifies those project requirements which need to be
addressed within that section of the Standard. In most sections, guidance is
further elaborated in:
Advisory procedures
Where it has been felt that further assistance would be useful, the advisory
sub-section offers additional comments, specific suggestions and sometimes
examples of how compliance with IS0 9001 may be achieved.
Note: In the first edition of this guide the purchaser received a current copy
of IS0 9001 for direct reference. This enabled the publisher to reproduce Section
4 of the Standard in the margin of the guide under the title 'Abstract'. In response
to readers' suggestions, and since most now have access to the revised standard,
this practice has ceased.
1. Scope
IS0 9001: 1994 Quality Systems relates to all the design, manufacture, supply,
installation, commissioning and servicing activities that determine the quality
and reliability of a process plant, as created by a multidisciplined engineering
project team to a specification agreed with a customer.
The design of each project has to identify and take account of the require-
ments of current legislation, International and National Standards and other
specifications that may be referred to in the design and by agreement with the
customer.
2. Normativereferences
The references given in IS0 9001 are self-explanatory. Additional text references
are listed on page 70 of this guide.
3. Definitions
In the guide the following definitions have been adhered to as closely as possible.
Contract: accepted order
Requirements mutually agreed between a supplier and customer, and conveyed
by any means.
Customer
The person(s), employer or organization, often referred to as the client, who
engages the contractor or engineering design department for the design, manu-
facture, supply, installation and commissioning of the process plant.
Design review
A formal, documented, comprehensive and systematic examination of a design
to evaluate the design requirements and the capability of the design to meet those
requirements and to identify problems and propose solutions.
Engineering contractor
A company which supplies engineering man-hours and equipment, either sepa-
rately or in combination, to a customer. This could be for a simple plant item, a
feasibility study or a complete process plant.
Engineering department
A team of engineers, technicians and tradesmen who carry out the same func-
tions as an engineering contractor but are permanent employees of the same
company as the customer.
Hazan
Hazard analysis
Hazop
Hazard and operability study
Product
Outputs of activities or processes
Project engineer
A person appointed by the project manager who has the responsibility and
authority for a particular discipline and for the management of specific aspects
of the project.
Project manager
The person employed by the supplier, having the authority to direct the contract
and meet the obligations of the supplier to the customer, to fulfil the project
requirements. Within an organization, this person may have varying titles from
Chief Engineer to Managing Director or Chief Executive.
Quality
The totality of features and characteristics of a product (process plant) or service,
that bear on its ability to satisfy the specified need.
Quality Assurance
All those planned and systematic actions necessary to provide adequate confi-
dence that a product (process plant) or service will satisfy specified requirements
first time.
Quality Plan
A document setting out the specific quality practices, resources and sequence of
activities relevant to a particular product, service, contract or project. In the
context of this guide it comprises the project co-ordination procedure and
departmental work instructions.
Quality Policy
The overall quality intentions and direction of an organization as regards quality
as formally expressed by top management.
Reliability
Ability of an item (plant) to perform a required function under stated conditions
for a stated period of time.
Sub-Confractor
The organization from which the supplier procures goods or services.
Supplier
The company - for example, contractor or engineering department - imple-
menting the quality system and providing the goods or service to the customer.
Tender
Offer made by a supplier responding to an invitation to satisfy a contract award
to provide goods/services.
4. Quality system requirements
4.1 Management responsibility
4.1.1 Quality policy
Guidance
The quality policy for any organization must have the total commitment of its
management to establish and maintain the quality system, which will ensure the
requirements of the customer are consistently achieved.
Once a clear commitment to a quality policy has been established, the Chief
Executive must delegate the responsibility and give authority to competent
persons who will ensure that the policy is fully understood, implemented and
maintained through its quality system.
The quality objectives for a process plant project should be that it is: 'fit for the
purpose' for which it is designed; it is completed within cost estimate; on
schedule and is reliable. It is also paramount that the plant is safe in operation
and that all potential hazards and risks have been identified and properly
controlled. It must be engineered to protect the health of the employees and the
public and not damage the environment.
Advisory procedures
For any organization supplying process equipment or services to IS0 9001 there
must be dedication to quality. This commitment must be total. It will emanate
from the Chief Executive and be transmitted through all levels of management,
engineering departments and include the craftsmen and fitters. The responsibil-
ity for achieving it must be defined clearly within the company's Quality
Manuals. It is normal practice for a policy statement on quality assurance to be
issued by the Chief Executive and placed at the forefront of these manuals.
4.1.2 Organization
4.1.2.1 Responsibility and authority
Guidance
The Quality Manual will include a management structure which will clearly
identdy who is responsible for the control of quality at each stage of a project.
Adviso y procedures
Projects will always vary in size and complexity, so companies have to decide
whether they have sufficient engineering resources to undertake a particular
project or whether they should employ the services of an engineering contractor.
Equally, engineering contractors may wish to engage sub-contractors. In either
of these situations the Quality Assurance department must have the responsibil-
ity and authority to ensure that the requirements of the company's quality
system are achieved.
4.1.2.2 Resources
Guidance
Once a project has been sanctioned and the requirements specified, a detailed
engineering design will have to be undertaken. This will ensure that the process
plant is engineered into an efficient and safe operating unit. The resource needs
of any project will be dependent on the value, the complexity, location and time
schedule. Therefore the project manager must ensure that the manpower
resource is qualified and trained. In addition, craftsmen must be competent and
skilled.
To assist the project manager he may require the services of a planning engineer
for resource allocation. He willidentlfy any shortfall inmanpower for thevarious
engineering disciplines for support in both the design office and on site. On major
projects, failure to idenbfy reasonably accurately- the resources required can
lead to delays which may impact on quality. It is essential that systems and
procedures are in operation during all phases of the project to ensure it is
completed on time within budget, and operates to its technical specification
within the overall project scope.
Adviso y procedures
Project management will provide adequate resources and trained personnel (see
Section 4.18 Training, page 67) to undertake the detailed engineering and main-
tain the integrity of the installation. This may include qualified and trained
engineers, technicians and craftsmen to undertake the following:
heat and mass balances;
design calculations of a mechanical or process nature;
software applications;
Hazop and Hazan studies;
environmental impact assessments;
integrated pollution control (PC) authorization;
detailed drawings for construction;
inspection during installation and erection;
commissioning and validation procedures;
quality and safety audits.
4.1.2.3 Management representative
Guidance
The Chief Executive or project manager will appoint a quality representative to
ensure the implementation of the company quality system. The representative
may need to employ in-house trained quality personnel or use the services of
outside specialist companies.
Adviso y procedures
The quality representative will be responsible directly to the Chief Executive or
project manager and will ensure that the requirements of IS0 9001 are imple-
mented and maintained. To resolve conflicts which may arise during the life of
a project and which can impact on the quality objectives - for example, time
schedules and cost - the quality representative must have no direct project
responsibility and have direct recourse to a senior manager/director who has
authority to resolve the matter.
4.1.3 Management review
Guidance
A management review is a systematic reappraisal of the quality system proce-
dures and objectives and will identlfy where they can be improved, based on
experience, or if they require any amendments or minor changes. The latter may
arise for reasons such as staff changes, new legislation and new computer
techniques. The review should not be confused with a quality audit, which sets
out to establish that the organization as a whole is operating to the demands of
the company's quality system and procedures. The review will, however, con-
sider the results of audits. The composition of the group formed to undertake
the review will depend upon the organization.
The frequency of the reviews must be established based on how critical they are
to the product (process plant) quality. In addition to the quality system review,
an engineering contractor would probably examine each project on completion
and implement any changes as highlighted by deficiencies which arose during
the life of the project. An engineering department may consider the suppliers'
performance, with special regard to their compliance with the Quality Plan,
company standards and safety procedures. An example of this would be to
ensure that a supplier of process plant had complied with a customer's number-
ing system for items of equipment, valves and pipework. They may also wish to
consider any standards and procedures, and review these documents, together
with any others which are issued to suppliers, to ensure that plant installations
conform to company engineering policy, not only during construction but also
on completion, to minimize maintenance.
Adviso y procedures
The quality system has to be reviewed at defined intervals. It is wise to review
its key elements on a 3-6 month basis and other sections at least annually, with
a supplementary review at the completion of each project. Project team members
involved in reviews could be selected from:
project manager;
quality manager;
planning engineer;
process engineer;
systems engineer;
civil and structural engineer;
mechanical engineer;
electrical engineer;
building services engineer;
instrumentation engineer;
health, safety and environment advisor;
purchasing manager.
Management review must include an appraisal of the quality system currently
in operation, so the agenda would include topics such as:
quality policy and objectives;
improvements to the quality system;
documentation and software control;
changes in working practices;
customer complaints and corrective actions;
audit reports;
corporate and future plans.
When a project management review is undertaken, items of discussion could
include:
project planning and organization;
variations to contract and cost control;
engineering rework;
customer complaints (where the customer may be either internal or external
to the company).
The review must be recorded and recommend to the Quality Assurance manager
any action needed to amend the procedures in the Quality Manual or to improve
the quality of the engineering activities. Actions should be monitored to ensure
they are implemented and effective. Care should always be exercised in making
amendments so as to ensure that the instructions are clear and concise and that
ambiguities are avoided. Any obsolete documentation must also be removed.
Changes must be approved and authorized by nominated responsible persons
in accordance with document and data control and change procedures defined
in Section 4.5.3.
4.2 Quality system
4.2.1 General
Guidance
The quality system must be based on the principle of 'do it once, do it right',
which will ensure the efficiency and safety of any process plant project. To
achieve this the company will have its own approved standards and procedures
which reference other International or British Standards and/or statutory regu-
lations and act as reference documents against which the system can be tested
for compliance. For each project a Quality Plan should be produced which would
be based on the standards and procedures given in the Quality Manual. The
distinction between these is shown by the following descriptions and their
relationship within the quality system by Figure 1, page 17.
4.2.2 Quality system procedures
Guidance
The Quality Manual covers the quality system procedures within the whole
operation of the organization with regard to Quality Assurance. This is often
written against the corresponding paragraphs of IS0 9001 Sections 4.1 to 4.20,
augmented as required by work instructions for the department.
The Quality Manual will be unique for each company and will recognize the
business environment in which the organization operates (being either a large
process engineering contractor or an engineering department - see Chapter 3
Definitions, pages 6-7).
Advi soy procedures
The Quality Manual should set out the quality policies, procedures and practices
within the organization. It may be found convenient merely to indicate the
existence and contents of the more detailed procedures which operate in other
departments. Each department may have its own procedures and practices, and
specific parts of the overall quality system could be arranged as follows:
process and design engineering procedures;
procurement;
sub-contractor control.
4.2.3 Quality planning
Guidance
Quality planning sets out the specific quality practices, resources available and
sequence of activities relevant to a particular process plant project (see BS4778:
Part 1 1987: 3.9"). Standards will be agreed prior to contract or detailed engi-
neering design. Any standards having a subjective element would initially be
approved by a procedure acceptable to both the customer and the supplier. An
example of this would be the quality of surface finish for an item of process
equipment -for example, satin or mirror finish for stainless steel plate.
For each project the Quality Plan would normally make reference to the Quality
Manual and only describe in detail the exceptions to the quality procedures. The
Quality Plan will include, or refer to, Inspection and Test Plans (ITPs) (see Section
4.10 Inspection and testing, page 45).
When the process plant is commissioned and is handed over for production, the
Quality Plan should have established the plant 'pedigree', and could be used as
the basis for all future maintenance and plant inspections.
Adviso y procedures
The Quality Plan is specific for the total project and it is the compilation of all the
individual quality plans required for all plant items and equipment which are
specific to the project. Typical individual Quality Plans include:
plant fabrication;
building construction;
environmental services;
pipework fabrications;
equipment testing;
commissioning;
validation;
plant optimization (if applicable).
4.3 Contract review
4.3.1 General
Guidance
Contract review is the beginning of the design validation span of a project as
defined in Figure3, Section4.4.8, page 26. It is essential for the customer to specify
the project requirements and extent of supply as accurately as possible, because
it is on this information that the contract is based and the order accepted.
The intention of contract review is to ensure that the requirements of the contract
are fully understood, that deliverables are identified, variances between tender
and contract are resolved and that the supplier has the technical, managerial and
manpower resources to complete the contract.
A contract is a legally binding agreement made between a customer and supplier
for the supply of services and/or equipment. However, for an engineering
department supplying s e ~ c e s or equipment within the company, the legal
requirements of a contract do not apply since the customer and the supplier
belong to the same company. The scope of review for a contractor will be broader
and may be more stringent than for an in-house engineered project as it will
include legal matters. The legal position with drawing up contracts is extremely
complicated, and is important for any process plant project, especially where
high capital investment costs are involved. IS0 9001 requires that procedures are
in place and are maintained to ensure the project scope is clearly defined in the
accepted order or contract document and that queries are resolved with the
customer in good time.
4.3.2 Review
Guidance
The review should consider:
(i) Contract basis
The contract conditions must be agreed between the supplier and the customer,
and will include such topics as terms of payment, contract price and delivery (or
completion). The form of contract may either be a lump sum payment or
reimbursable as described in the Institution of Chemical Engineers Model Forms
of Conditions of Contract for Process Plants Suitable for Lump Sum Contracts (Red
~ o o k ) ~ or Reimbursable Contracts (Green ~ook)".
It is unlikely that the signed formal contract will be the totality of the agreement.
Therefore a procedure must be followed to agree which documents, drawings
and specifications will be included in the contract. The contract should clearly
state the order of precedence in the event of a conflict of documentation (see
Section 4.6 Purchasing, page 32). There will be a number of important aspects
but most crucial is the definition of the 'purpose for which the plant has to be
fit'. A precise definition of all conditions that could affect the design or perform-
ance of the plant, including composition and quality of feedstock and product,
service demands and environmental performance must be agreed before the
contract is accepted.
It must also be remembered that a contract for the supply of process plant may
carry heavy financial risks in the form of performance warranties, which the
contractor would be prudent to limit. It is recommended that performance
guarantees be written into the agreements so that each party is able to assess
their own liability in the event of the plant failing to meet the performance.
A project programme which details all factors which can influence the final
completion should also be issued to the customer.
The review procedure should ensure that clear agreement is obtained on the
precise terms ahd conditions which pertain to the contract, particularly for
export, where it is essential to establish which national legal system applies.
Legal advice for the preparation of such a procedure should be sought.
It is recommended that representatives from the project team should be involved
as early as possible in the project, preferably at the pre-contract stage, to ensure
they have a good understanding of the customer needs.
(ii)
Variations behoeen contract and order requirements
The contract between the customer and supplier will commence immediately
the order has been acknowledged. Therefore, pre- and post-contract docurnen-
tation mustbe checked to ensure that the scope of supply for which the contractor
has quoted remains unchanged. All documents must be compared thoroughly
with the enquiry and differences resolved with the customer before contract
acknowledgement.
(iii) Contractor capability
Before proceeding, the contractor should establish that he has all the necessary
financial, technical and managerial resources to carry out the contract require-
ments. A detailed review of the engineering requirements for the project is
essential. This, together with the estimated cash flow during the project, are often
critical factors.
4.3.3 Amendments to contract
Guidance
Amendments to the contract must be reviewed promptly, with variation orders
issued and acknowledged.
All contract changes and additional work instructions raised during the contract
period must be strictly recorded and the customer advised promptly of the
impact of these variations on price, delivery and other factors affecting quality
- for example, reliability.
4.3.4 Records
Guidance
Contract reviews must be documented to ensure proper accountability is main-
tained. The records could be administered by a check-list procedure which
would assist proper accountability. They will be specific to equipment suppliers
and used to compare their performance with the original project programme to
monitor key completion and delivery dates.
Such records will provide objective evidence that the Quality Assurance proce-
dures have been followed (see Section 4.16 Control of quality records, page 64).
4.4 Design control
4.4.1 General
Guidance
This section of the Standard covers the design verification span referred to in
Figure 3, Section 4.4.8, page 26. Procedures for design control should recognize
that, in executing the design of a process plant, a supplier will need to draw on
the expertise of a number of engineering and other disciplines, whose activities
are co-ordinated by a project manager or project engineer. These disciplines
include all or some of the following, depending on the size and scope of the
project.
Technical functions:
chemical;
mechanical (including vessel, machinery, piping and plant layout specialists);
electrical;
instrument;
systems software;
civil and structural;
risk analysis and safety;
environmental impact;
building services;
quality assurance;
construction;
commissioning.
Other functions or departments:
purchasing;
non-destructive testing and inspection;
planning;
shipping - dimension constraints imposed by transportation routes and
regulations;
legallinsurance.
Quality Assurance depends not only on the quality of work produced by the
different disciplines, but also on the efficient co-ordination and interfacing of
their activities. Company procedures should address this requirement.
Adviso y procedures
In order to cover the whole range of activities it is recommended that the quality
system (see Section4.2 Quality system, page 12) will require two levels of written
procedures. These are:
standard procedures which apply to all projects and are referred to in the
Quality Manual;
supplementary procedures which are specific to a particular project and
written in the Quality Plan.
The Quality Manual and Quality Plan together form the quality system as shown
in Figure 1.
The Quality Manual comprises:
Standard procedures which are not project-specific including:
(i) Company procedures which:
define the company's overall policy;
describe general methods of implementing company policy;
describe responsibilities of relevant functions and personnel.
(ii) Departmental procedures which:
describe how the company's policy within a specific department is imple-
mented;
provide detailed instructions regarding mandatory methods of design.
QA System
4.2
Quality manual Quality plan
4.2.3 4.2.3
Company Departmental Project co-ordination Departmental work
procedures procedures procedure instructions
4.4.1 4.4.1 4.4.1 4.4.1
Standard procedures -
To be considered for all projects
Supplementary procedures -
Project specific
1 Figure 1 Elements of the QA system.
The Quality Plan comprises:
Supplementary procedures which are project-specific including references to the
standard procedures where appropriate. It is these supplementary, project-
specific procedures, which comprise the Quality Plan as defined in this guide.
(i) Project co-ordination pvocedure
The project co-ordination procedure is normally written by the project manager
to ensure the companfs procedures and the customer's requirements are met
for a particular project.
It should include the following:
scope of project;
project team and organization;
quality objectives;
communication between the customer, contractor and subcontractors;
project schedule;
payment schedule;
file references; -
progress reporting;
special features of the project - for example, design codes;
regulatory requirements, climatic conditions, health, safety, hazard and envi-
ronmental impact;
nominated personnel;
document distribution schedule;
electronic data transfer;
drawing and document numbering;
drawing and specification registers;
control of design changes;
and any other special requirements not covered by these.
(ii) Departmental work instructions
Departmental work instructions should be written for each engineering disci-
pline and function by the relevant department manager, or delegated by them
to a responsible, competent person.
They should include the following:
collection and collation of data;
documentation;
project schedule;
calculations:
- methods;
- approved sources of physical property data;
- software programs validated for use on the project;
specifications:
- format;
- maintenance of registers;
design standards and codes;
checking and approval;
reporting;
maintenance of records;
and any other special requirements of the project not covered by these.
4.4.2 Design and development planning
Guidance
This requires the supplier to set up an organization to give fu.1 managerial effect
to multi-discipline co-ordination and planning referred to in Sections 4.1.2.2 and
4.4.1, pages 9 and 16. In particular, the responsibilities across interdepartmental
functions need to be clearly defined. In practice this is equivalent to a project
manager (contractor or engineering department) setting up the project team for
a particular project within the overall organization of the company.
The supplier needs to ensure that within both the company organization, and
the project team, adequately trained and experienced staff are appointed for
specific projects to execute the level of responsibility assigned to them.
Adviso y procedures
A detailed plan should be drawn up at the commencement of every project,
identifying in a logical sequence the activities necessary to achieve the overall
project schedule. They are classified by department with responsibilities for the
activities indicated. These plans cover all relevant aspects of design, procure-
ment, construction and commissioning, depending upon the company's contrac-
tual arrangement with the customer. The timing of key design reviews is shown
on the detailed plan. The project schedule may be presented in the form of a bar
chart or a planning network, consistent with the size and type of the project. For
major projects this activity will require the involvement of a specialist planner.
AU project plans should be approved by the project manager.
The project co-ordination procedure (part of the Quality Plan) should identlfy
those personnel with s upe ~s or y responsibiIities for the project, plus any other
key personnel.
The departmental work instructions should assign other personnel to design
verification activities. They should be demonstrably qualified and experienced
for the assignment and level of responsibility undertaken.
The progress of the work should be reviewed regularly. Following these reviews
the overall project schedule should be updated to show the current situation and
the progress achieved on the plan to date. Actions resulting from these reviews
should be recorded.
Related written procedures should cover:
project planning;
progress reporting;
design reviews.
4.4.3 Organizational and technical interfaces
Guidance
This recognizes the distinction between people and technical interfaces within
an organization. It requires the supplier to identify where these interfaces occur
and to have documented procedures to cover them. A typical, and generally
difficult, example is the interface between those responsible for piping and plant
layout and all other disciplines. There is frequent interplay between location of
equipment and its size or specification, which depends on detailed information
from manufacturers of proprietary equipment.
Aduiso y procedures
The organizational and reporting relationships of personnel assigned to a project
should be shown on an organization chart contained in the project co-ordination
procedure. Technical interfaces between each engineering discipline and the
method of review of design documents should be defined in a company proce-
dure, with detailed implementation contained in departmental procedures.
These procedures should describe the scope and purpose of every design docu-
ment produced, the originating department, the source of input data and the
departments to whom the document is issued. The number of review stages and
the method of review should also be defined.
Interfaces with the customer and external organizations, contractors, licensors,
regulatorylstatutory bodies, third party inspectorates, vendors and subcontrac-
tors are managed by the personnel identified in the project co-ordination proce-
dure. Some of these interfaces may be described in the contract, or further
discussion with the customer may be required. Departmental procedures should
describe the normal methods of managing the interfaces with outside bodies.
It is emphasized that it is unlikely that organizational and technical interfaces
can be adequately serviced by departments working in isolation, however close
their adherence to written procedures. Interfacial activities should be monitored
by a project manager or project engineer and this role defined in the project
co-ordination procedure.
Technical interfaces with vendors of equipment should be managed by specialist
engineers by preparing detailed specifications and monitoring the design output
to ensure compliance with them. Depending on company procedures, or perhaps
on the size of the project, commercial interfaces will be managed by the same
specialist engineer or separately by the purchasing department.
Related written procedures are:
production of project co-ordination procedures;
design document interfaces;
validation and authorization of design documents;
management of vendor's data;
various departmental procedures;
IT strategy. I
4.4.4 Design input 1
Guidance
The availability of design data, and its state of development at the commence-
ment of a project, can vary considerably. Typically, design data will originate
from the customer, technology licensor, pilot plant trials, laboratory experiments
or from the supplier's knowledge and experience.
Procedures should exist to ensure that designers are kept up to date with
regulatory requirements and to ensure conformity with these. At project concep
tion, there should be liaison with the appropriate authorities to confirm that the
regulatory requirements have been correctly interpreted. It is recommended that
a database enquiry is made to ensure that the latest regulatory documents,
standards and codes of practice are applied.
It is important that the starting data and source are documented, and that
suitably qualified staff review its content, iden* where essential data is missing
or ambiguous, and resolve shortcomings with its originator.
Adviso y procedures
The customer will define plant capacity and product quality, mandatory stand-
ards and other essential documentation. Such requirements, where the supplier
is a contractor, should form part of the contract reviews as described in Section
4.3 Contract review, page 13.
As the design progresses, additional input data will be received from the
customer, licensor, vendors, consultants and other bodies, and this data should
be similarly documented and reviewed for accuracy and completeness.
AU the procedures identified knSection 4.4.3 should contain sections relating to
documentation and software review and the use of design input data.
4.4.5 Design output
Guidance 1
Company and departmental procedures define the types of documents (see
Section 4.2 Quality system, phge 12) that should be produced in order to meet
the requirements of different types of projects. Additionally, the scope of the
required design output will normally be defined contractually in terms of the
drawings, schedules, specifications, calculations, manuals and dossiers to be
produced for the project, which may either be by hard copy or electronic means.
Where appropriate, particular attention should be given to documenting the
basis of health, safety and environmental protection measures for the project.
Advisory procedures
Design output must:
(a)
Fulfil the specified design input needs
Although based on the starting data, account must be taken of any contingencies
added, changes imposed from external sources (see Section 4.5.3 Document and
data changes, page 31), and smaller changes which arise as the design develops.
Designreviews are required to ensure that the design remains in accordance with
the design input documentation.
(b)
Contain or reference the conditions of acceptance
Duty specifications, whether related to the whole plant or to individual items of
equipment, should clearly define criteria such as characteristics to be checked,
tolerances, inspection requirements, commissioning trials and guarantee per-
formance tests.
(c)
Identify those characteristics of the design that are crucial to the safe and proper
functioning of the product
Safety reviews should be performed routinely to identify potential hazards and
the measures taken to safeguard plant, personnel, the general public, the envi-
ronment and the integrity of the manufactured product. Responsibility will
normally extend to the provision of operating and maintenance manuals both of
which should contain instructions on safe working practices.
Related written procedures:
safety reviews;
hazard analysis (Hazan);
hazard and operability studies (Hazop);
safety critical items;
environmental impact assessments;
IPC authorizations;
verification and authorization of design documents;
validation;
inspection;
departmental procedures.
4.4.6 Design review
Guidance
For any major project the design review is one of the most important stages to
ensure its successful completion. At the contract review stage the project is in
embryonic form and the design requires to be developed and controlled continu-
ally to ensure it meets the demands of the specification. Unlike mass production
processes, which manufacture product on a repetitive basis, a process plant
project is often a 'one-OW. Sometimes the project may be similar to an earlier
installation but even then the location, climatic conditions or available utilities
may differ. Therefore, the supplier has to ensure that the detailed engineering
design, as issued for construction and installation, is suitable for purpose. This
requires to be monitored by careful reviews.
Input data (see Section 4.4.4 Design input, page 21) may be incomplete prior to
the commencement of design, as it is often not technically necessary nor com-
mercially viable, to gather all design information prior to contract. This generates
the need to gather additional technical information for the design to proceed.
Changes which take place must be checked for their impact on the total design
which must be managed and dove-tailed together. If this is not co-ordinated by
the project manager then the individual discipline engineers will work in isola-
tion of each other and this will result in 'clashes of interest'. A simple example
of this is if design reviews are not regularly undertaken, the space occupied
within a service duct could be allocated by both the electrical design section for
cable trays and the services engineer for ductwork, resulting in a clash of
hardware. These are relatively easy to amend at the design review but can be
expensive and time consuming to correct at the installation stage. The project
manager must ensure that the design is co-ordinated and misunderstandings
between disciplines are avoided. This will require continual vigilance as the
design progresses and good communications must exist between all the inter-
ested parties.
The design review should be seen as formulated stage inspection. During the
design phase it is extremely important that all representatives with any interest
in the design take an active and constructive part in the design review, such that
the right decisions are made as early as possible. Figure 2 on page 24 illustrates
typical input groups.
The role of the project manager is strategic for the whole project and would not
normally involve detailed engineering decisions. Decisions should be made at
the lowest possible levels providing that the basis of the information on which
the decisions are made is sound. Particular points of issue should be relayed to
the next tier of project management until they are resolved by the project
manager.
Figure 2 Typical input groups for the design review.
Design documentation must be checked and approved (see Section 4.4.1, page
16) but in addition and most importantly revisions and amendments must be
documented. The information arising from these changes must be quickly and
clearly communicated to other engineering disciplines and involved individuals.
The documentation should also clearly state who authorized the change and the
reason for it. Equally, any impact a change may have on capital cost and time
must be quickly estimated and forwarded to the project manager.
It is important that only valid documents are used for design purposes; therefore
if changes are made and issued it is essential to withdraw the previous document
issue from circulation. When superseded documents are retained they should be
clearly identified.
Adviso y procedures
The organization of a project team will consist of a group of experienced
engineers from various disciplines reporting to the project manager. He in turn
will report to an organization structure representing the customer. At the pre-
liminary design stage when schematics are being prepared and developed - for
example, piping and instrumentation diagrams (P&IDs), electrical distribution,
control systems - this work may be undertaken individually by the sections.
However, once general arrangement drawings are commenced it is essential that
the requirements of all disciplines are accurately co-ordinated. Clash control at
this stage of the project is critical. Modern CAD systems can recognize and
highlight clashes; the alternative is to undertake this operation through careful
and systematic checking on the drawing board.
Once the project has been completed, the 'as-built' drawings which have been
conscientiously amended and checked will form the basis of the validation of the
process (see Sections 4.4.8, page 26 and 4.16, page 64).
Procedures should be in place for:
project organization;
change control;
drawing reissue and withdrawal of previous issue;
documentation and data receipt and distribution;
design approval.
4.4.7 Design verification
Guidance
Written procedures should be used to ensure that the design is verified at
predetermined specific stages during the project, and that these stages are
defined in the project co-ordination procedure in the Quality Plan.
Adviso y procedures
All design verification activities should be documented. This requirement im-
poses the need for all significant design documents to bear 'drawn by', 'checked
by' and 'approved by' entries, and for review meetings to be minuted. Such
review meetings require actions by named individuals or departments and a
follow-up procedure should ensure that action is taken.
The design verification measures should include:
checking in accordance with the departmental procedures and departmental
work instructions;
design reviews by engineering management, project management and con-
struction management;
planned and regular project and company internal quality audits;
checking of calculations by alternative means, if appropriate;
verification of software, for in-house use;
review of past experience with similar projects;
pilot plant trials/small-scale laboratory tests;
hazard evaluation tests.
Related written procedures:
quality control of software for in-house use;
validation and authorization of design documents including those produced
electronically by CAD;
the preparation of departmental work instructions;
departmental procedures.
4.4.8 Design validation
Guidance
This is a new clause in the 1994 revision of IS0 9001. A diagram illustrating the
differences and connections between verification and validation is given in
Annex A of the BSI Quality Assurance Guide to the 1994 Revision of BS 5750, I S 0
9000~. It is reproduced here as Figure 3.
review
Design
input
Design
I plan 1
I I * - 4 Responsibilities I
I 1 . 1 ~nterfaces I
1 - 1 Verification I
Design Validation
output
in use
Figure 3 A diagram illustrating the revised design control model. (Annex A from
the BSI Quality Assurance Guide to the 1994 Revision of BS5750, IS0 9000~ is
reproduced with the permission of BSI.)
Design validation covers the need to establish that the finished process plant
meets all the requirements of the contract. This means that the Quality Plan must
include procedures for testing all equipment to ensure that design parameters,
specifications and outputs have been complied with. It will include, for example,
the criteria for acceptance of guarantee runs by the customer.
Briefly, validation encompasses the design verification procedures by extending
them to cover commissioning and handover criteria of the finished plant to the
customer. It covers Sections 4.3 to 4.15 of the Standard.
Design verification compares the design input with the design output at each
stage of design control - see Section 4.4, page 16.
Design validation and verification together defirie how quality is built into the
product throughout the project so that the product is right first time to customer
requirements - the essence of Quality Assurance.
Part of design validation is to identify the critical components and functions.
Certain projects may require a lesser degree of design validation than others.
Validation is extremely critical within, for example, the nuclear and phannaceu-
tical industries where the products of processes are life threatening, but takes a
much lower profile on projects such as mineral treatment (for example, gravel
extraction).
Adviso y procedures
The completed plant design will be validated on completion of the following
stages which will be encompassed within the Quality Plan.
(i) Erection completion
The completion of construction of buildings and the installation of equipment
and materials is checked to be in accordance with the drawings, documents and
specifications in the contract.
(ii) Mechanical completion
Mechanical completion means that the fabricatioA and installation of equipment
and its off-site and on-site static testing has been completed in accordance with
contractual specifications and detailed design drawings.
I
(iii) Pre-commissioning 1
Pre-commissioning is the period when the installation is checked for complete-
ness and the equipment is test run and prepared for operation as far as practica-
ble to ensure it is safe to receive and process feedstock.
Such test running and preparation of individual items of equipment or systems,
referred to as functional testing, is normally performed using clean water, air or
inert gas as substitutes for process materials.
At the conclusion of this phase, which may partly overlap the mechanical
completion period, the plant is said to be 'ready for ccomrnissioning'. At this
point the plant is ready to receive normal feedstock.
fiv) Commissioning
Commissioning begins when normal feed is admitted for the first time to the
plant. During commissioning, the plant throughput is adjusted to design oper-
ating conditions to give a period of full production prior to the demonstration
of performance tests.
(v) PelfOrmance Tests
Known also as guarantee or warranty tests. These are technically supervised and
recorded tests which verify that plant, systems or equipment within a plant meet
the performance guarantees in accordance with the contract. Once mutually ac-
cepted they conclude the design validation span referred to in Figure 3, page 26.
Written procedures are required to cover all these stages. Specifically, check-lists
are required to provide objective evidence that, for example, erection is complete
or the plant is ready for commissioning. Completeness or readiness in this
context is seldom 100%; it usually refers to a condition which is mutually
acceptable to supplier and customer with exceptions documented in a reserva-
tion list ( or punch list) with a commitment by both parties to elimination of the
identified reservations in a timely manner. Safety must be the overriding factor
to be taken into account before commissioning any part of the plant.
Each stage should be accepted by the signatures of the supplier and customer on
certificates and accompanying reservations lists, culminating in the %andover
certificate' described in Section 4.10.5 Inspection and test records, page 51.
Depending on contractual requirements the completed plant may be tested as
an integrated plant running for the duration of the test period, or the test may
be the culmination of individual sub-systems and systedequipment perform-
ance tests at the design rate.
The pharmaceutical industry has its own stringent requirements for validation
to meet the requirement of Good Manufacturing Practice (GMP). In thisindustry,
erection and mechanical completion is frequently referred to as 'installation
qualification' (IQ), pre-commissioning as 'operation qualification' (OQ) and
commissioning and performance tests as 'process qualification' (PQ).
4.4.9 Design changes
Guidance
Written procedures should be established and maintained for the identification,
documentation and appropriate review and authorization of all design and
software changes and modifications. Procedures should ensure that the implica-
tions of change in tenns of safety, design effort required, cost and time are
considered, documented and authorized.
Advisoy procedures
There is considerable potential for change to affwt adversely the quality of the
design, unless it is effectively managed. Adverse effects can be created by
additional work causing a dilution of resources, or by inadequate dissemination
of change information throughout the design team. Even with adequate distri-
bution of change documentation, effective action following the change cannot
be assured unless there is a systematic review procedure to follow up all actions
to completion. Changes to documents is discussed in Section 4.5.3 Document and
data changes, page 31.
Related written procedures:
change control;
safety review;
software control.
4.5 Document and data control
IS0 9001 accepts that documents, data and records may be in any media - for
example, hard copy, electronic and microfiche - but does not deal with the
inter-relationship between Quality Assurance and information technology (IT).
Software plays a critical part in most quality systems and close attention must
be paid to ensuring its suitability and quality. Quality Assurance of software is
described in IS0 9000-3'~, but the 'Tickll" ~ u i d e ' ~ describes best practice for a
quality management standard for development and validation of software. It is
a standard devised by IT professionals with DTI and British Computer Society
support. IS0 9000-3 is included in part 2 of the 'TickIT' Guide. Readers are advised
to refer to this publication for more detail.
4.5.1 General ~ ~
Note: In the 1994 revision
7
, 'data' has been added to the title of this section. For
any process plant project, the flow of accurate and relevant information must be
quickly distributed to maintain the completion schedule. Controls should en-
compass documents and drawings from external origins such as the customer
and statutory bodies and those generated within the project. The data may be
received in any form such as hard copy or electronic media.
The Standard demands procedures for the contrbl of all documents and data
relating to the requirements of the Standard itself, as well as for the project. It
includes the quality system documents as described in Section 42, page 12.
4.5.2 Document and data approval and issue
Guidance
It is important that an effective system of document numbering and control is in
place from the early stages of a project. This is when many of the documents are
initiated, yet it may be a time of rapid change as the design concepts are
developed. The controls also apply to software.
For many design organizations there are sufficient dissimilarities between pro-
jects or types of projects that it is impractical to develop an all-embracing single
system for document control. To overcome this difficulty a two-tier system of
document control is recommended:
(a)
A system implemented at company level which covers the control of
company and departmental procedures - for example, those issued by the
Quality Assurance department or by a company standards engineer.
(b) A system implemented project by project covering the issue and re-issue
of project-related material including drawings, specifications, data sheets, orders,
plans and other documents.
The document control system is required to identify each document, its date, its
revision number (or a similar issue identifier) and its distribution. It will also
help subsequent audits if the reason for the revision is included. The implemen-
tation of such a system requires the compilation and regular updating of a
document register.
Procedures should idenhfy those persons authorized to initiate or to approve the
issue of each type of documentation.
Written procedures are required to control all documents and data which have
a bearing on quality. Control of documents should be such that:
(a)
they are issued appropriately and to locations (for example, onsite) where
the functions are being performed;
(b)
obsolete documents are promptly removed from use and are stamped or
otherwise identified as 'obsolete' if retained for record purposes;
(c)
important documents which are retained for future reference - for exam-
ple, soil reports - should be identified and archived. This data could then be
placed on an electronic database for retrieval.
Adviso y procedures
Documents should be initiated, prepared, approved and issued in accordance
with written procedures. Not all documents are prepared 'in-house' under such
control, and documents from external sources - for example, vendors' or
sub-contractors' data - should be numbered, reviewed and approved by
authorized personnel before further dissemination.
Records should be maintained of the issue and re-issue of 'controlled' documents
toenable these to be updated or withdrawn as appropriate, when obsolete. On
ocksions it will be necessary to issue a document to personnel not on the official
distribution list, to enable a particular, perhaps previously unanticipated, task
to be performed. Written procedures should take account of this eventuality, but
it is customary, as a minimum, to stamp such documents 'uncontrolled' as an
indication that the recipient will not automatically receive revised documents.
Related written procedures should cover:
initiation, preparation, approval and issue of company and departmental
procedures;
production of project ceordination procedures;
drawing, document numbering and software;
validation of design documents.
4.5.3 Document and data changes
Guidance
It is ideal if changes to documents and software are reviewed and approved by
the same functions that performed the original review and approval. Where
practicable, the nature of the change should be identified in the documents or on
attachments. For example, changes to drawings may be highlighted by drawing
a cloud or bubble around the change, and changes to text may be highlighted by
the use of a revision number or letter in the margin. Alternatively, change lists
can be prepared as an attachment.
Adviso y procedures I
Registers of documents and software should be maintained, i denwng the
current revision (or issue) and date. Company and departmental procedures are
not project-specific and will normally be expected to change infrequently. How-
ever, drawings and specifications in use on a particular project will be subject to
frequent updates. Such documents are often initiated at a 'preliminary' status,
and ultimately be raised to 'for purchase' or 'for construction' status. Registers
of project documentation should contain entries defining the status of each
document.
The project schedule (see Section 4.4.2 Design and development planning, page
19) details the timing of the issue, updating and re-issue of design documents.
In addition to the planned re-issue, documents should be re-issued after a
practical number of changes have been made or if even a single, but significant
change has been made. Minor changes to the design maybe found to be necessary
during the construction and commissioning phases of the project. It is important
that neither health, safety, environment nor design intent should be compro-
mised through unauthorized changes. Written procedures should address the
feedback of information from site, the authorization of any changes found to be
necessary, and the production of as-built drawings for record purposes.
Related written procedures should cover:
initiation, preparation, approval and issue of company and departmental
procedures;
change control;
production of project co-ordination procedures;
site feedback of engineering matters;
software change reviews.
4.6 Purchasing
4.6.1 General
Guidance
The term 'purchased product' as used in IS0 9001 refers to the procurement of
materials or services for inclusion in the supplier's own product or senices.
Technical interfaces with sub-contractors of equipment should be managed by
specialist engineers preparing detailed specifications and monitoring the result-
ing design output to ensure compliance. This point is amplified in Section 4.4.3,
page 20 and Sections 4.6.2 to 4.6.4, pages 33-39. The ultimate customer or user
might himself regard the term 'purchased product' as being the process plant or
senices provided by the supplier. The customer need not, however, regard
himself as lacking a framework for ensuring the adequacy of what to him is
'purchased product'. A suitable contract could be taken from the Institution of
Chemical EngineersModel Forms of Conditions o f Contractfor Process Plants Suitable
for Lump Sum Contracts (Red ~ o o k ) ~ or Reimbursable Contracts (Green ~ook)".
Frequently the contract is not a stand-alone document, and the final agreement
may incorporate aspects of the invitation to bid and the supplier's tender. Where
the possibility of conflict between documents exists, the contract should clearly
state an order of precedence.
Advisory procedures
Procedures should be applied both to individual items of equipment, serving
mechanical, electrical, control or other functions, and also to materials which are
usually referred to in the industry as 'bulk materials' - that is, material which
does not normally have to be installed in a unique location. Examples are piping,
pipe fittings, cable, cable trays and reinforcing bar.
The first step is to iden* suitable vendors and sub-contractors (see Section
4.6.2 Evaluation of sub-contractors). The next step is to analyse the bids, both
technically and commercially, to ensure that equibment and materials quoted
conform to specified requirements. Company procedures should address the
following three main requirements:
(i) Classification of bids
Where appropriate, equipment and materials or entire sub-contracts are classi-
fied (typically into two to four groups), so that high value/technically com-
plex/long delivery/safety-critical equipment receives closer scrutiny than low
value/standard design/off-theshelf equipment.
(ii) Technical analysis of bids
Technical analysis should be performed in a struckwed manner, based mainly
on a determination of:
compliance with performance requirement;
compliance with specification(s);
adequacy of scope of supply.
Where defiaenaes are noted, further communication may be needed with the
vendor to determine whether there are any cost implications in achieving a full
compliance with requirements. If so, this should be fed forward into the com-
mercial appraisal.
(iii) Commercial analysis of bids
Commercial analysis should be based on:
cost including packing, transport and insurance;
delivery period;
an assessment of the vendor's capabilities, as amplified in Section 4.6.2;
other commercial considerations -for example, terms of payment and valid-
ity of offer.
On occasion, commercial considerations will be such that a re-examination of the
technical analysis will be called for. Where this is done on commercial grounds,
it will be necessary for a competent engineer to distinguish between the essential
technical requirements and those which are desirable or preferred.
Related written procedures should cover:
vendor selection and bid analysis.
I
I
4.6.2 Evaluation of sub-contractors ~
Guidance
The term dsub-contractors~ should be regarded as a general term embracing
anyone who provides goods or services to the supplier (see also Chapter 3
Definitions, pages 6-7). Companies with a high level of activity in design and
procurement normally favour a structured approach, leading to established
approved sub-contractor and vendor lists which are regularly updated as data
becomes available from completed projects. Customer requirements for pre-
ferred sub-contractors require a project-specific approved supplier list. A small
company, or one infrequently undertaking design and procurement, may review
only the vendors selected for the contract. However, the basic principles outlined
above still apply.
Advisory procedures
(i) Categorization
It is recommended that sub-contractors should be suitably categorized within
their own areas of technical and commercial activity.
For example, a four category system could be employed:
Category 1: fully acceptable Quality AssuranceIQuality Control system;
Category 2: acceptable Quality AssuranceIQuality Control system with some
minor deficiencies;
Catego y 3: inadequate Quality AssuranceIQuality Control system;
Category 4: not suitable for use.
As described in Section 4.6.l(i), page 33, equipment and materials or entire
sub-contracts should be classified into groups which reflect the critical (or
otherwise) nature of the goods or services under consideration.
Company standards and the project co-ordination procedure should then ad-
dress the level of surveillance and inspection which goods and services should
receive from the supplier when purchased from a particular category.
Level of inspection (see Table 1):
(a) inspection requirements to be specified individually;
(b) full time inspection necessary;
(c) minimum inspection required.
Table 1 -Required levels of inspection
Supplier category
8
1 2 3
Critical purchases (a) (a) or (b) Cb)
Non-critical purchases (c) (a) or (c) (a)
It should additionally be noted that there may beg requirement for third party
inspection - for example, a statutory requiremeAt for steam raising plant, or a
requirement imposed by the customer or an insurer. In locations outside the UK
there may be additional mandatory requirements.
(ii) Selection of sub-contractors
Selection of sub-contractors and vendors will nor lly be achieved using one or
more of the following means:
1
(a) an assessment by the supplier of the sub-contractor or vendor, by ques-
tionnaire, audit or both;
(b) recent experience with the sub-contractor;
(c) evidence of current accreditation to IS0 9001 or IS0 9002.
Company procedures should define how these are used to assign subcontractors
and vendors to categories 1, 2 and 3, and the period of validity of such an
assessment.
It may also be appropriate to conduct a financial assessment for a critical (for
example, long delivery) purchase. Such an assessment may be conducted by
financial analysis of the latest company accounts, or by means of a report from
a credit rating organization.
(iii) Establishment and maintenance of records
The approved subcontractor and vendor list should detaiI the product range
and the category assigned in (i) above. It is possible that a sub-contractor or
vendor may be in different categories for different items in his product range.
The period of validity of the information should also be entered in the list.
Supporting information such as audit reports and photocopies of accreditation
to IS0 9001 or IS0 9002 should be retained.
Periodic review is necessary in order to update the information and to ensure
that quality system controls are effective. This may be obtained by feedback
relating to the actual performance of sub-contractors.
Related written procedures should cover:
assessment of vendors and sub-contractors;
i
company approved list of vendors and sub-con I ractors.
4.6.3 Purchasing data
Guidance
~ ~
Purchasing documents will normally consist of a technical specification s u p
ported by general specifications (if applicable) and a commercial section relating
to validity of tender, cost, delivery, guarantees, scbpe of supply, the company's
and the customer's right to access for inspection purposes and other agreed
conditions of purchase. Specifications will sometimes unavoidably contain in-
formation of a confidential nature, in which case there may be a need for a secrecy
agreement to be included.
Purchasing documents should state clearly the data and drawings to be provided
to and by the supplier or sub-contractor, and the time schedule for the provision
of this data.
Adviso y proceduws
It is customary that, in order to minimize the chance of ambiguity or the omission
of important information, a company should develop standard forms for the
specification of all classes of equipment and materials normally encountered on
process plant or specific to the company's line of business. Such forms may exist
as pre-printed paper or, as is increasingly the case, on computer.
All equipment should be provided with a unique title and/or reference number.
Bulk material components should be specifically identified. It will frequently be
appropriate to append to the equipment specification, information and specifi-
cations of a more general nature which are applicable across the project. Such
information and specifications should describe, for example:
climatic conditions;
availability of utilities and services;
standards for design construction quality and the environment (effluents,
emissions, noise);
painting;
insulation;
inspection and test requirements;
delivery instructions.
Each specification, whether specific to a particular item of equipment or of a
generalnature, should be annotated withanissue (or revision) letter (or number),
dated and paginated.
Each specification should be signed as 'prepared by', 'checked by' and 'approved
by' in accordance with company procedures, in order to ensure that documents
are reviewed and approved at an appropriate level before being released for
purchasing.
Related written procedures should cover:
numbering of equipment and materials;
preparation of technical specifications;
standard conditions of purchase;
the issue of purchase orders.
4.6.4 Verification of purchased produci
Guidance
I
I
Whilst brief definitions are given in Chapter 3, it is appropriate to define and
explain here some of the t e r n used in more detail to avoid confusion. In the
supply chain, many elements of that chain have a customersupplier relation-
ship, but two of these relationships can be highlighted as being of particular
relevance. They are shown diagrammatically in Figure 4. For example:
(i)
The ABC Chemical Company is the customer of the DEF Contracting
Company (the supplier), to whom equipment is provided by the GHI Pump
Manufacturing Company (the sub-contractor). Similarly the supplier could be
an internal engkeering department within the ABC Chemical Company.
Customer
ABC Chemical Co
Contractor
DEF Contracting Co
Sub-contractor
GHI Pump Manufacturing Co
Sub-contractor
JKL Seal Manufacturing Co
- Direct lines for s~pplier/customer relationships
----4---
Indirect lines for supplier/customer relationships
Figure 4 ~ustomer/contractor/sub-contractor/supplh matrix of relationships.
37
Alternatively:
(ii)
The DEF Contracting Company (the purchaser) may be providing an
entire process plant, with the GHI Pump Manufacturing Company (the supplier)
providing a pump for installation as part of the process plant. The JKL Seal
Manufacturing Company would be a sub-contractor to the GHI Pump Manufac-
turing Company, providing seals for use in the pump.
4.6.4.1 Supplier verification at sub-contractor's premises
Guidance
Where plant and equipment is purchased from a sub-contractor the level of
inspection is dependent on the nature of the supply and this is specified in the
purchase order.
For critical items an individual Quality Plan is prepared and acceptance criteria
agreed prior to manufacture. A stage inspection procedure identifies the 'hold'
points and the acceptance authority will venfy that the equipment has been
produced in accordance with its specifications.
For a process plant project, the sub-contractor's premises could be either a
specific manufacturing unit or an on-site, temporary construction facility. In
either situation, the supplier must satisfy himself that the sub-contractor's facili-
ties are adequate and systems are in place which venfy the quality and ensure
that the product produced is in accordance with the purchasing document.
Particular attention must be paid to project-specific, onsite, temporary premises.
Since these are not permanent establishments, channels of communication must
be clear and acceptance levels defined. Strict adherence to safety procedures such
as hot work permit and permit-to-work must be enforced.
4.6.4.2 Customer verification of sub-contracted work
Guidance
In addition to Section 4.6.4.1 the customer or his representative has the right to
venfy that any sub-contractor's product conforms to specification. This again
will apply to any component manufactued either on-site or produced as a
proprietary item.
For specific items of equipment, it may be necessary for not only the customer
to inspect, but also his representative. An example of this would be the stage
inspection of a pressure vessel by an independent insurance inspector to venfy
that the equipment has been constructed in accordance with the design and
fabrication code.
Any customer inspection would not absolve the supplier of his overall respon-
sibility for the supply of individual items of equipment or the plant installation.
Adviso y procedures
The Standard is very clear with regard to the verification of components such as
pumps, but Sections 4.6.4.1 and 4.6.4.2 also apply to on-site construction and
equipment servicing. Figure 4, page 37, gives a graphic interpretation of the
relationship between customer, supplier and sub-contractor, to help the reader
clearly understand the supply trails which exist in the execution of a process
plant project.
I
Related written procedures should cover:
inspection of equipment and materials;
subcontract software supply; I
stage inspection procedure in accordance with the Quality Plan;
responsibilities for inspection - general and project-specific;
notification of readiness for inspection;
lines of communication;
records;
nonconfonnances;
safety procedures; I
permits-to-work
4.7 Control of customer-supplied product
Guidance
The use of 'customer-supplied product' (often referred to as 'free issue material')
is a common practice within an engineering project and frequently affords
benefits. For example, the customer might provide electric motors to all of his
sub-contractors who are supplying pumps or other items of equipment. Alter-
natively the customer might supply components such as valves from his own
stores to ensure uniformity across his production site. The supplier will normally
be responsible for the control, safe-keeping of customer-supplied
product after receipt.
I I
If equipment, such as valves or motors, is supplied by the customer to a
contractor then care should be exercised regarding the warranty covering the
items supplied. I
Normally the warranty of the process plant will dommence on completion of
practical handover or after successful commissioning and would probably
exclude 'customer-supplied product' (for example, valves and motors). The
supplier must ensure that any equipment issued to him by the customer will not
adversely affect the overall integrity of the process plant, and should consider
the impact of failure of such items after commissioning and during the process
plant warranty period.
Advi soy procedures
The relationships between 'supplier' and 'customer' are defined in Section 4.6.4
and Figure 4, page 37. The customer should provide documentation to the
supplier for the identification of material, whether provided to a sub-contractor
for incorporation in plant or equipment, or provided directly to site. It should
include data to enable the recipient to verify that material is to specification and
instructions on storage and installation, which will ensure that the quality of the
process plant is maintained.
Related written procedures should cover the following (see also Section 4.15
Handling, storage, packaging and delivery, page 60):
stores stock control;
equipment handling on-siteloff-site;
packaging;
nonconfonnances.
4.8 Product identification and traceability
Guidance
In the context of the design and supply of process plant, 'product' should be
regarded in very broad terms as comprising the design (that is, drawings,
calculations and specifications), procuring equipment and materials required for
the whole project and eventually installing and commissioning the complete
plant.
Requirements for traceability are determined by the operating conditions, reli-
ability demands, the nature of the equipment and the materials of construction.
These will be defined by the design, specified by procurement, confirmed by
inspection, and registered by documentation, and are an integral part of the
Quality Plan.
Adviso y procedures
(i) Design
All items of equipment should be provided with a unique title and/or reference
number (see Section 4.6.3 Purchasing data, page 35). This can be done by
allocating identification numbers to items of equipment, instruments and pipe-
lines. Schedules should be maintained and regularly updated.
Bulk materials (described in Section 4.6.1 Purchasing, page 32) should also be
adequately identified, specified and quantified, which is customarily referred to
as a 'material take-off'. Company standards should address the degree to which
the individual components of a bulk material are provided with identification
numbers. For example, an order for pipe of a particular size and specification
should have a unique identification, but if supplied in 6 metre lengths, each
length need not normally be separately identifiable (see Section 4.8 Product
identification and traceability (ii)).
In regarding the process plant as 'the product', it follows that design information
which appears in calculations, specifications and drawings should be demon-
strably up to date and traceable. This overall requirement can be developed into
the following recommendations:
documents should idenhfy equipment and daterial within the body of the
product (process plant) by using a systematic numbering system;
calculations should contain references to basic data, calculation methods,
software used, physical properties and assumptions;
drawings, specifications and other design documents, their issue or revision
number and date, should be identified in schedules which are continually
updated. It should be possible for users to determine the source of data used in
the preparation of each drawing. This can be achieved by either tabulating
'reference drawings' on each drawing prepared, or compiling and continually
updating a 'register of input data';
data from outside sources - for example, vendors' drawings - should be
similarly listed;
a maintained filing system will permit access to current information.
(i i ) Equipment and materials
The concept of product identification and traceability starts with the technical
specification and associated purchasing documents, and culminates in the instal-
lation on site. The technical specification and purchasing documents should state
the requirements for material identification (for example, by tagging or colour
coding) and for traceability. Irrespective of the means of identification, it will
need to withstand the rigours of transportation, weather, site storage and con-
struction. I
All relevant certificates, manufacturing recordk and inspection tests should
clearly be traceable to all materials and components for unique identification.
Usually the most important aspect of traceability is that of material certification,
where the chemical composition and mechanical properties are certified by the
sub-contractor. For noncritical applications, a letter of conformity from the
sub-contractor may suffice (for example, confirming that carbon steel piping in
low pressure service is in accordance with the required standard), but for critical
applications (for example, exotic alloys in corrosive service), it may be necessary
to call for individual 'mill' certificates. This information is often assembled in the
final package of documentation.
Material identification can, on occasion, require considerable investigation to
ensure total conformity with specification. If, for example, it is essential that the
wetted parts of a pump be constructed in a particular material, a review not just
of the major components but also of the individual parts (for example, shaft seal)
will be necessary to prevent a potential nonconformity.
Where segregation between materials of a similar appearance is essential (for
example, piping in different grades of stainless steel), it will be appropriate to
consider confirmatory material identification at defined stages during fabrica-
tion, at sub-contractors' works, and before delivery or start-up. Such testing may
be specified as random or up to 100% at any stage. Portable spectroscopic
equipment may be used to provide suitable nondestructive testing. The use of
stringent procedures to ensure that the specified materials are installed is often
termed 'positive material identification'.
Where a large number of the same components - for example, bolts, fixing clips,
pipe hangers, brackets - are ordered, it may be appropriate to check the quality
of these items by random sampling. In cases where this is considered important,
specialist advice on statistical sampling techniques to give the required confi-
dence limits may be sought (see Section 4.20 Statistical techniques, page 69).
Related written procedures should cover:
numbering of equipment and materials;
material take-off;
valve and piping specifications;
numbering of documents;
filing systems/records/documentation;
material identification;
the preparation of project co-ordination procedures;
sampling procedures for specified components.
4.9 Process control
Guidance
Note: The term 'process' within the text of IS0 9001 refers to the stages in the
design, manufacture, construction, installation and commissioning of either a
part, component or assembly of the plant. In this context it does not refer to the
control of the chemical process for which the plant has been designed and
constructed.
Construction, installation and commissioning of a process plant is very different
from operating a repetitive production process where operating conditions and
acceptance parameters are well known. Process plants are often either 'one-off
or improvements to existing plant and technology, possibly involving novel
design techniques. By their very nature they are oken required to function under
arduous conditions of temperature and pressure and in corrosive environments,
sometimes working at the boundaries of technology. The materials, technology,
and service conditions used may not, therefore, be fully understood by other
than a few experts or specialists. Such plant is also inherently costly and conse-
quential loss arising from malfunction can be high, both in direct cost and in
health, safety and environmental terms.
It would, however, be wrong to assume that all items of plant require the same
detailed level of control. Whilst all items of the plant must function correctly, not
all will be highly stressed, operate in harsh environments, require high levels of
integrity or undergo complex manufacturing processes. Project planning is
essential but the degree of detail to be specified during the construction and
installation stages will depend on the complexity of tasks, operating needs,
potential hazards, safety and the skill and knowledge of personnel available for
carrying out the work. When these factors could result in failure to meet the
specified quality, the performance and safety of the plant could be jeopardized.
The activities should be conducted in accordance with written procedures by
competent personnel against which progress can be monitored. It is this provi-
sion of written instruction for the management of design, manufacture, installa-
tion and monitoring that is generally referred to as controlled conditions.
The supplier must review the design, manufacture and installation schedule to
identify and plan the controls required for the critical stages and supply of key
items of plant, either in part or as a whole, which demand controlled conditions.
The review should include maintenance procedures.
It may not always be possible to show by testing that the completed plant item
or installation of components meet the required quality level. Vessel parts may
be inaccessible, and not amenable to testing without destroying its integrity.
Similarly, bulk items for which 100% testing may not be practical will still require
a high degree of planned inspection to ensure material quality (see Section 4.20
Statistical techniques, page 69).
For example, the Quality Plan for closed vessels must include the stage inspection
for internal welds which cannot be verified after closure. Final inspection may
establish the coating thickness and colour of paint but will not confirm that
pre-treatment, surface preparation and inter-coat time were to specification. A
similar situation will hold true for rubber and glass lining. Heat treatment plants
produce timeltemperature graphs, but these do not show the location of mate-
rials within furnaces, the siting of thermocouples or record furnace atmosphere
conditions for critical treatments. Calibration and maintenance records must be
available to ensure the reliability of the process.
Procedures must be established to speclfy fully: the way in which the activity is
to be carried out; when and how verification of quality is to be assured and
approved; and how the material is released before further work is undertaken.
Procedures should include not only the manner in which manufacture, installa-
tion and testing are conducted but also how manufacturing, test materials and
equipment are to be controlled. In addition procedures may speclfy the qualifi-
cations required of operators and Quality Control personnel, together with the
record of test results and certification that must be established to prove that
quality aims were achieved.
Advi soy procedures
Written schedules, method statements and departmental work instructions form
part of the Quality Plan (see Figure 1, page 17) and will specify how, and in what
sequence, tasks will be carried out. They will define practices and processes; state
standards of workmanship, skill and knowledge levels; speafy final quality
levels, acceptance parameters for mitical characteristics, and the authority
needed to validatelaccept the finished product. Again particular emphasis
should be given to health and safety working practices and to environmental
protection in the documentation. Control of such documentation is defined in
Sections4.4.1, page 16 and 4.5, page 29. Activities which require control are listed
below and require procedures for identification, filing and retrieval.
Training of personnel:
-skills (for example, welding);
- knowledge (technical education);
- qualification;
Special projects -these will include:
-installation;
-handling and storage;
-inspection and test plans;
-testing procedures/sampling;
Manufacturing processes;
Software application/development;
Control of test and inspection equipment;
Acceptancelrejection criteria;
ScrapIreworWrepair practices;
Certification requirementslcertifying authorities;
Records to be generated;
Equipment maintenance records.
Any special process associated with a project should be specified in the Quality
Plan. Special processes fall generally into two categories; those related to either
manufacture and installation, or verification activities like inspection and testing.
Both these categories will be covered in the Quality Plan - that is, in the project
co-ordination procedures andlor the departmental work instructions, examples
being:
Manufacture and installation:
- special assembly/installation procedures; I
- construction requirements;
-heat treatments;
- cleaning/sterilization;
- control or certification of equipmentlpersonnel;
-weld procedures;
- safe working practice - permit-to-work;
- method statement for qualified processes;
Verification activities:
- pressure testing requirement;
- plant commissioning;
- validation;
- non-destructive testing.
4.10 Inspection and testing
4.10.1 General
Documented procedures will be in place for the inspection and testing activities
I
I of the supplier.
These procedures will be referred to in the Quality Plan even though they will
be part of the company procedures (for example, calibration methods) applying
to all projects and contained within the Quality Manual (see Section 4.2, page
12). When a new procedure is identified which is specific to the project in hand
it needs to be written into the Quality Plan.
i
Inspection procedures are written according to the level of inspection required.
Certain componentslparts may require higher levels of inspection than others
due to their critical nature. Procedures have a hierarchy of precedence gradually
increasing in detail as the risk of component failure rises. A simple example of
this could be the inspection of cooling water pipework. Normally this does not
require any detailed inspection procedures. However, if the cooling water duty
was associated with a nuclear facility then it would immediately be identified as
a critical component and strict inspection procedures enforced.
Inspection and Test Plans (ITPs) are included in the Quality Plan and are an
important part of commissioning. Testing procedures which define all levels of
acceptance criteria for all functions involved in the project must be available.
They should clearly identify instruments to be used during testing and calibra-
tion and define when the procedure requires review.
Records must be maintained of the date and results of inspection and tests, the
levels of acceptance and the accepting authority.
Adviso y procedures
Inspection and Test Plans, and procedures for their control, must be available
within the Quality Manual for ensuring that components and their installation
meet the product specifications. These apply to the test procedures of various
engineering functions involved in the project:
mechanical testing;
electrical testing;
instrumentation testing;
software testing.
4.10.2 Receiving inspection and testing
The standard distinguishes between three aspects of this topic as described in
the following subsections.
Guidance
The extent of inspection and testing is dependent on various factors including
the material or equipment itself, the specification, safety, operating conditions,
supplier capability. The type of inspection may vary from stage inspection
during manufacture, through functional testing, physical checks of material or
it may be a document review. The full extent of the inspection and testing
required for a particular process plant by the customer is normally specified in
the Quality Plan. If any of the inspection or test results are not in compliance with
it then Sections 4.13 and 4.14 apply and the necessary action must be taken.
It is worth noting that leak testing can be a valuable part of the equipment
inspection procedures. This may be a simple hydrostatic head test or a defined
pressure test to identify small cracks which may not be shown up by
non-destructive techniques (NDT). This is particularly appropriate for heat
exchangers where the temperature used for the test should also be considered.
Adviso y procedures
Material and equipment inspection may be undertaken either at the supplier's
or manufacturer's premises, or after delivery to site.
(i) Predelivery inspecfion
This will cover a combination of supplier's, third party's and customer's
inspection to ensure that equipment or material is manufactured and sup-
plied in accordance with design documentation. For the supply of plant or
equipment, inspection at various stages of manufacture may be required and
the responsibilities for inspection and testing b i the supplier (contractorlsub-
contractor) or customer should be defined.
(a) Supplier's (contractor/subcontractor) inspectiol?
Figure 4 (page 37) shows the supplierlpurchaser relationships. The contrac-
torlsub-contractor (supplier) will operate in accordance with contract purchase
orders and stated International, British and company Standards together with
any codes of practice and will inspect and witness tests accordingly. All inspec-
tion and test reports will be issued direct to the customer or via the contractor.
(b) Customer's inspection
The purchasing system should cover the issue of all inspection and test docu-
mentation prior to delivery of the material and equipment. The customer's
inspection is to ensure:
compliance with the contract order;
1
double check on critical features;
~
avoidance or replacement of third party inspection;
a check on features required by the customer, not necessarily defined or
required in the Standards or Codes;
fulfilment of all the requirements for third party inspection (assuming the
customer has appropriate resources);
authenticity and witness of the third party inspection.
(c) Third party inspection
Third party inspection is used either in place of, or in additional to, customer
inspection. The reasons for third party inspection are:
statutory or insurance demands;
need of specialist expertise;
lack of resources of the customer or supplier.
The level of third party inspection is dictated by statute, insurance requirements
of the customer, demands of a Standard or Code, or company policy. Third party
inspection can also be utilized to provide independent verification of material
identification as a means of ensuring traceability back to source.
(ii) Post-delivery inspection
Procedures should spec* the method for controlling acceptance and release of
incoming material. There may be routine stores procedures with sampling plans
and acceptance criteria together with procedures for identifying material which
specifies the documents against which verification shall be made. Such docu-
ments will include the purchase order (which may list drawings, and data sheets)
the Quality Plan and the release documentation provided by the sub-contractor
supplying the incoming materials.
The purpose of these procedures is to ensure that the quality of incoming
material is established prior to release for manufacture or installation.
Guidance
The level of receiving inspection and testing will be determined by reference to
the subcontractor's quality performance. If a single product is to be obtained
from two separate subcontractors then, depending on their quality system, it is
acceptable to apply different degrees of inspection. Table 1 (see Section 4.6.2
Evaluation of sub-contractors, page 34) offers guidance as to the required level
of inspection for critical and noncritical purchases. This approach of categoriza-
tion of subcontractors may also be applied to companies supplying a similar
produd.
Implementing an assessment programme and informing the sub-contractors of
their relative rating will frequently encourage them to address and improve their
quality system so that they remain an approved supplier.
Adviso y procedures
Each subcontractor will be categorized according to the Quality AssuranceIQual-
ity Control systems they operate. Where deficiency is detected during assess-
ment, audit or supply, the subcontractor may be given the opportunity to
improve their quality system.
Periodic review is necessary to establish that sub-contractors continue to operate
to an acceptable category and that they are at least maintaining the current level
of quality, but more importantly striving to improve.
Related procedures should cover:
sub-contractor assessment;
company approved lists of vendors and subcontractors;
performance records of sub-contractor;
Inspection and Test Plans (ITPs);
Guidance
Where overriding production or installation schedules require the use or incor-
poration of materials or components for which the quality level has not yet been
established, their use is permitted provided that procedures are implemented
which ensure that the components may readily be located and removed or
rectified should they subsequently prove to be deficient.
Process plants are becoming more complex with the use of exotic materials and
sophisticated control systems. It is therefore essential to check at the earliest
opportunity that the component, material or system for control is 'fit for the
purpose' for which it has been designed. Perhaps the most simple and common
example of the need for positive identification is in the manufacture of vessels.
Today, there exists a very wide selection of chromelnickel alloys for many
different corrosive applications, so the selection of the correct alloy for an
appropriate duty is critical. It is imperative to ensure that any plate or tube
purchased is proved to be what was recommended and subsequently ordered,
prior to fabrication. Once fabrication commences, failure to identlfy correct
materials of construction can lead to increased costs or, at worst, equipmet
failure.
Adviso y procedures
Any material not tested or verified as in Section 4.10.2.1 must not be processed,
manufactured or installed. Any equipment failing tests as specified in Section
4.10.2.1 must not be used if it does not comply with Codes, Standards or
insurance requirements. If plant or material fails to comply for other reasons (for
example, dimensions) it may be installed if agreed on concession with the design
authority at the appropriate level. A signed record of the deficiency and the
concession should be appended to the appropriate documentation - for exam-
ple, drawing or specification.
A concession procedure (see Section 4.13 Control of nonconforming product,
page 55) should allow for the urgent release of material prior to verification
provided the relevant design and procurement authorities are contacted, risk
assessments carried out and suitable identification and audit trails established
to enable immediate recall.
4.10.3 In-process inspection and testing
Guidance
The requirement of Sections 4.10.3 and 4.10.4 is that there must be evidence of
inspection and testing in accordance with the Quality Plan and of the authorized
release of equipment for installation or use.
The essence of Quality Assurance is to build quality into the whole project from
inception to completion. The Quality Plan will include Inspection and Test
Plans (ITPs) stating inspection and testing requirements during construction,
installation and pre-commissioning with reference to relevant International,
British and company Standards and Codes. Functional checks on plant opera-
tion should use non-process fluids (for example, water or air) where possible.
Prior to commissioning with non-process fluid the plant should be cleaned.
Chemicals should not be introduced to the plant until all inspection and testing
is completed in accordance with the written procedures. The IChemE's book
Process Plant ~o r n r n i s s i o n i n ~~~ is a useful reference.
Adviso y procedures
Due to the complexity of in-process inspection and testing, it is usual to establish
a small group of engineers and other specialists (for example, chemists, insurance
inspectors) who write the Inspection and Test Plans and commissioning proce-
dures. Components common to a number of items of equipment should have
test and record sheets readily available. For example, an electric motor could be
tested for:
explosion protection;
direction and freedom of rotation (hand and power);
stoplstarts;
alarms;
lubrication;
speed of rotation, rpm.
Similarly, test plans should be available for items of equipment such as pumps,
filters, agitators and any other individual item of process equipment. In addition
to testing the installed component and sub-assemblies, other inspection and test
records should include:
verification that the installation is in accordance with drawings and specifica-
tions, especially flowsheets, general arrangement drawings and isometrics;
pressure andlor vacuum testing of systems is in accordance with an agreed
pressure testing specification;
recording of service availability, steam, water, compressed air together with
the operating conditions, temperature, pressure, flow, etc.
equipment function - for example, control and safety systems, noise and
vibration;
recording of all results, identifying deficiencies and taking action in accord-
ance with company procedures;
intermediate certification and documentation.
4.10.4 Final inspection and testing
Guidance
This section is an important part of design validation (see Figure 4, page 37).
After in-process inspection and testing of the plant, the intermediate certification
and documentation will have been completed. Suitable chemicals may then be
introduced in accordance with the commissioning plan which includes start-up
and operating instructions, prepared as part of the project Quality Plan. It may
be necessary to clean the plant with chemicals compatible with those to be used
in the manufacturing process prior to the introduction of raw materials and/or
feedstock.
Final checks must be carried out on, for example, interlock systems, alarms and
any previously untested flanged connections such as those spaded during
testing. The commissioning may include 'dummy runs' on compatible chemicals
without manufacturing the final product.
Advi soy procedures
Start-up should be carried out with the appropriate number of suitably qualified
personnel who have available the necessary analytical and engineering resources
in accordance with the Inspection and Test Plans (ITPs) and commissioning
procedures. This stage of the project validates that the design conforms to the
contract specification.
Monitoring and recording of the process itself, including utilities demand,
should be carried out and the results made available by the commissioning team
to all relevant personnel.
The plant must be commissioned to demonstrate that the specified design
throughput, yield, efficiencies, product quality, risk management and environ-
mental criteria have been met. Deviations from the design conditions and
established engineering practices will be noted and remedial actions agreed and
implemented.
The plant may continue to operate with deviations from design conditions only
if, in the judgement of the project manager, the risks associated with the opera-
tion are properly controlled and a concession is authorized.
Related procedures are:
Inspection and Test Plans;
precommissioning and commissioning;
trial batches;
corrective actions and concessions.
4.10.5 Inspection and test records
Guidance
Records of all inspection and test results obtained during design, manufacture
and commissioning of the plant and of corrective actions and concessions must
be kept and archived for a stated period. These records provide objective
evidence that the Quality Plan has been complied with and may form part of the
lifetime plant record provided to the customer.
The document which gives evidence that the process plant (product) has passed
all inspection stages satisfactorily and complies with the customer's specifica-
tion, is generally referred to as the 'handover certificate'.
Inspection and test records are most important for design validation, especially
where it is necessary to demonstrate that the process remains in a validated state,
and this will also assist with future routine maintenance schedules. Records and
documentation required for regulatory bodies must be archived to be available
for future retrieval (see Section 4.16 Control of quality records, page 64).
With complex process plant installations it is good practice to institute a han-
dover procedure which can be phased to include the different stages of plant
handover. This would not only ensure satisfactory completion of the various
engineering functions, mechanical, chemical, electrical and control, but would
ensure total plant compliance with safety procedures and meet the needs of the
engineering maintenance department.
Handover documentation is frequently centred around the original contract (see
Section 4.3 Contract review, page 13) and can sometimes become quite conten-
tious on points of contract detail. If a performance guarantee has been specified
in the original contract then procedures must be written to substantiate that the
terms and conditions of the process guarantee have been achieved and this must
be verified by representatives from the supplier (contractor) and the customer.
Adviso y procedures
Handover procedures should ensure the requirements of the contractor specifi-
cation have been fully met. Phased handover procedures will enable the various
stages of commissioning and handover to be agreed systematically and a p
proved by all the nominated departments, engineering, Quality Assurance and
safety. Certain important facets of the project, such as safety as identified during
the Hazop, may require particular examination by safety audit at project com-
pletion prior to handover.
Records for compliance with specification, which will include water commis-
sioning and trial batches, will be signed off by the appropriate persons with
authority to release the plant for production.
AU project records must be carefully collated and issued to the customer as proof
that the product has met its design and quality requirements. As defined in
Section 4.16 the supplier should store the original records and issue duplicate
copies to the customer for future reference. These records provide the objective
evidence that the quality system and contract requirements have been met.
Related procedures should cover:
component inspection and release;
partial handover;
handover certificate.
4.11 Control of inspection, measuring and test equipment
4.1 1.1 General
Guidance
The general statement requires documented procedures to control, calibrate and
maintain measuring and test equipment to ensure that measurements under-
taken are appropriate to the accuracy specified in the design documentation and
that the results obtained are valid. If specified, the customer or his representative
has the right of access to technical data on test equipment.
Advisory procedures
Procedures must establish responsibilities for ensuring that equipment or soft-
ware to be used provides the accuracy required by the tests specified in the
design documentation. The core of the system is the control of uniquely identi-
fied equipment or instructionslsoftware by the systematic application of calibrat-
ing, updating, storing and issuing procedures, and the provision of adequate
records. Adequate uptedate instructions for using equipment must be main-
tained as required by complexity of equipment, and experience and training of
the operator. The process must ensure that individual equipment can be readily
identified, its current calibration status readily assessed prior to use and provide
documented evidence of the validity of calibration. The procedure needs to state
functional, departmental and individual responsibilities in the selection, control
and use of equipment.
4.1 1.2 Control procedure
Guidance
IS0 10012-115 provides detailed guidance on the methodology and the records
to be established in the control of inspection and testing equipment.
The Standard requires not only the control of quantitative measuring devices but
also covers test software.
Advisory procedures
Assuming that the suitability of equipment has to be established prior to p r e
curement or issue, the basis of control is theunique identification and calibration
(metrological confirmation) of equipment and maintenance of appropriate re-
cords. Calibration must be traceable to International Standards. Where this is not
possible the basis for confirmation has to be documented. Items requiring
calibration before use must state that requirement. Provision must be made for
jigslfixtures to be set and checked before use and establish that change has not
occurred during use that would invalidate the settings. Controls for the issue of
latest software/documentation must exist. The procedures establish functional
and departmental responsibilities for the control, storage and issue of equipment
and those of persons using equipment.
Equipment must bear a unique identifier, which should also indicate calibration
status and expiry date. Records, traceable to the unique identifier, must describe
the equipment, show calibration (confirmation) dates and the result of confirma-
tion. The record must state the calibration interval, which is appropriate to the
level of accuracy required, type of instrument, drift, user environment, etc, and
may bebased on prior experience. Statistical methods may be applied toestablish
such intervals (see Section 4.20 Statistical techniques, page 69). The record should
indicate the source of calibration (which itself must be subject to control),
relevant environmental conditions during calibration, the permissible error and
the uncertainty of measurement pertaining to the equipment. It must identlfy
the person carrying out the operation, provide unique identification of certifica-
tion recording the calibration and show limitations of use. Once calibrated the
equipment must be protected by procedural and/or physical controls from
unauthorized change.
Calibration may be undertaken in-house or by external organizations which are
themselves accredited. Various computer-based applications are available for
record management. Records will be subject to the requirements of Section 4.16,
page 64.
Where material has been tested using equipment which is subsequently found
to be faulty the procedure must make provision for disposition of that, and any
other products which may have been tested with the equipment, since the last
date of acceptable accuracy. This procedure must assign responsibility for iden-
tifymg, segregating and revalidating and disposing of material based upon the
significance of the deficiency and perceived risk. It interfaces with the procedures
for product recall. An example of this could be any equipment for a pressure
duty found to have been tested with a faulty pressure gauge. Test records should
identdy which item had been incorrectly pressure tested and a retest arranged
using a verified accurate pressure gauge.
4.12 Inspection and test status
Guidance
Process plant projects are usually 'one-off' installations and need to meet the
requirements of the contract (see Section 4.3 Contract review, page 13). Regular
project reports should be issued during testing and commissioning, highlighting
the current progress and indicating what action is being taken. This should
continue until such time as the plant is fully operational and any action taken
under Section 4.13.1 should be recorded.
Adviso y procedures
Documentation is required to chart the progress of manufacture, installation,
testing and commissioning activities and should show all results including
failures and corrective actions taken. The physical identification of material and
components should also be defined.
Part of the design documentation should include a schedule for future routine
testing of the plant and/or its components. During the installation and commis-
sioning of the complete process plant, or individual component, a procedure
should exist to indicate the test status, which must include marking or tagging
to show that plant is either awaiting inspection, is satisfactory, is quarantined or
is rejected.
The Quality Plan containing the inspection and test results from the construction
and commissioning phases would be placed in a dossier to establish the pedigree
of the plant, and could then be issued to operating and maintenance personnel
or archived as quality records (see Section 4.16 Control of quality records, page
64) for regulatory and design validation purposes.
4.13 Control of nonconforming product
4.13.1 General
Guidance
The five phases for the evolution of a process plant are design, procurement,
manufacture, installation and commissioning, and at any stage nonconformance
with the specification may arise.
This section specifies written procedures for identifying and recording noncon-
formance and specifying the method for evaluation, correction and comrnunica-
tion with concerned parties. It also specifies the persons or functions having the
competence and authority to decide how the nonconformity is to be resolved.
As written, this section implies that the product is a physical entity, but it is also
applicable to an activity or service.
Adviso y procedures
(i) Design
Evidence of nonconformance with client specification, quality system standards,
statutory requirements and safe working practices may arise from design veri-
fication activities (see Section 4.4.7 Design verification, page 25) - for example,
design audit, Hazop studies or deficiencies identified during design evolution.
Procedures must specify the methods and controls to be used to record and
correct deficiencies, the manner in which drawings and other documents are to
be marked up and how a 'hold' is put on design and dependent activities to
prevent abortive work. The documents must identify who has the responsibility
and authority to correct technical, commercial and financial deficiencies. The
procedures must also interface with those for the control of design change and
concession (see Sections 4.4.9 Design changes, page 28 and 4.14 Corrective and
preventive action, page 58).
(ii) Procurement
Procurement may be considered as the interface with manufacturers and provid-
ers of services which implement design or service requirements, defined in the
contracts and specifications.
The assessment of a sub-contractor's capability (see Section 4.6.2 Evaluation of
sub-contractors, page 33) will have reviewed their potential for providing satis-
factory goods or services. However, inspections and tests, which may either be
those carried out internally by the subcontractor or externally by the project
organization, may reveal nonconformance. The quality system must quickly
identdy and segregate nonconforming material to prevent inadvertent use. The
sub-contractor's system must record and report deficiencies to appropriate
departments within the organization for resolution and action - for example,
technical matters to design and programme implications to planning.
Procurement activities for the control of nonconformance will interface with
design change control procedures, inspection and verification activities, and
control of quality records. It is essential that they include procedures for control
of concession and purchase order variations.
(iii) Manufacture
Any nonconformance to specification should be identified as soon as practicable
at critical stages in manufacture. Nonconforming material or equipment should
be clearly identified and prevented from further use until corrected and author-
ized for use (see Section 4.14 Corrective and preventive action, page 58).
Construction materials may be metals or non-metals or a combination of both,
(an example of the latter being rubber-lined mild steel plant). Company and
National Standards must be used for the design of the plant which must include
the inspection and test procedures appropriate for the fabrication. This would
apply to 'in-house' produced items as well as any plant purchased from a
fabricator.
Pressure vessels must be constructed to an appropriate code such as BS 5500.
Procedures should state what class of fabrication is required for the design duty
and the need for independent inspection and test to ensure that the vessel will
comply with Pressure System Regulations. Manufacture also covers the assem-
bly to correct tolerances, surface finish, painting, etc.
(iv) Insfallation
Discovery of an unsatisfactory condition, whether by inspection of incoming
material or during installation, requires well managed and co-ordinated com-
munication of corrective actions to all relevant departments and contractors.
Recording, reviewing and disposing of nonconforming material may be similar
to that employed in the manufacturing processes. Segregation of nonconforming
material can be difficult at the installation stage, so identification and recording
of deficiencies needs careful thought and control. They can best be done with a
unique master list under the control of the project engineer or a nominated senior
member of the construction team.
(v) Commissioning
Deficiencies detected during commissioning may well be due to faulty design or
manufacture, incorrect installation or inadequate performance. The comrnis-
sioning procedures should specify how nonconformances are recorded and
communicated to the appropriate function(s). It is extremely important that a
nonconformance which may be hazardous to personnel or damaging to the plant
which is identified during commissioning is dealt with urgently. Where this is
impossible, commissioning may have to be restricted or stopped completely.
Procedures for recording and resolving deficiencies must interact with those for
design change control, concession and procurement. It is imperative that the
records refer information and data back to the project review procedure.
The procedures must also provide for identifymg, segregating and disposing of
defective process products to prevent their inadvertent use or entry into main-
stream production. These may then be managed through an IS0 9002 quality
system. A useful reference on this topic is Process Plant omm mission in^'^.
4.13.2 Review and disposition of nonconforming product
Guidance
It has already been stated that, where deficiencies are revealed at any stage, there
must be established procedures for recording and referring the nonconformance
to competent persons having the authority to decide what corrective action must
be taken. Where the product is a process plant, technically and contractually
dedicated to a particular function and performance, the competent person will
normally be the appropriate functional engineer. Occasionally requests for
concessions may be made to the customer when it can be demonstrated that an
alternative design option may be equally effective and overcome the deficiency.
Adviso y procedures
This clause offers four options, (a)-(d), for disposition of nonconformance, but
due to the dedicated one-off nature of the plant it is unlikely that option (c),
re-grading for alternative applications, is possible for major items of plant.
Sometimes individual items of equipment, say pumps or valves, may be re-
graded to a less demanding duty without affecting the overall plant performance.
The options, however, may be used as a basis for resolving disposition at design,
procurement, manufacture, installation or commissioning.
The acceptance of any nonconforming product by concession must take into
account the view of the customer, provided that statutory obligations and other
legislative parameters are met. If it transpires that the plant fails to perform to
the specified requirements and is rejected, this would almost certainly result in
a legal dispute because of the large capital investments usually involved.
4.14 Corrective and preventive action
4.14.1 General
Guidance
This section has two fundamental requirements:
(i) To identify and record causes of nonconformance in equipment or plant or
the quality system, and to specify corrective actions to rechfy the deficiency and
identify actions to prevent their recurrence.
(ii) To implement and record changes to procedures arising from corrective
action.
The general paragraph specifies the requirement for documented procedures
describing the controls to be operated in correcting and preventing the recur-
rence of observed or perceived nonconformance in the quality system, product
or process. Action to correct nonconformance will depend on the significance
and perceived risk. Any resulting change to documentation must be recorded
along with evidence that actions have been implemented.
4.14.2 Corrective action
Guidance
Company and department procedures should clearly define organizational and
functional responsibilities for effectively initiating and completing actions to be
taken to correct all nonconformances. They will cover customer complaints,
plant, process and quality systems with the aim of discovering and recording the
root cause of nonconformance in order that the observed deficiency can be
rectified. Procedures must include the requirement for monitoring the specified
action or change to ensure that it is effective.
Nonconformance related to the quality system is also addressed in Sections 4.13
Control of nonconforming product, page 55 and 4.17 Internal quality audits, page
65.
For the project the Quality Plan defines responsibility and authority for specify-
ing and monitoring the corrective actions to be taken for design change, material
rework, installation variations or plant modification.
Usually the most difficult task is to establish what really went wrong to cause
the nonconformance. Frequently, it can be a combination of several factors, such
as a wrong welding rod, inadequate training, inaccurate instruments or incorrect
calibration. For corrective actions to be effective, it is essential to put sufficient
technical effort into establishing the real cause and then specify what action to
take and to ensure that it is completed satisfactorily. Where necessary written
procedures should be modified to include any resultant changes.
Adviso y procedures
Where deficiencies in systems, design, equipment, materials or the process plant
itself are detected, those persons and functions responsible and authorized must
investigate and resolve the nonconformity and its cause. Depending on the
nature of the deficiency, the complexity of the solution and the risk involved, the
corrective actions themselves may vary from a simple instruction to a fully
documented procedure or work instruction. The specified action should be
monitored to assess its completion and effectiveness. This may be encompassed
within existing inspection/surveillance instructions or may require a unique
instruction or re-audit of a system. In each case, records must clearly show that
the action has been carried out and that the desired result has been obtained. If
not, the matter must be carried forward and referred to the appropriate function
and to Quality Assurance.
The duty to specify and control corrective action will be based on technical
competence, knowledge of the system and organizational authority. The general
principle should be that the functional head of the department where the
nonconformance arose should take responsibility for co-ordinating the correc-
tive action and following it up to effective completion. It has been found useful
to have multidisciplinary corrective action teams comprising the skills and
experience required for solving the particular problem. In matters concerning
design, it may be referred to the design engineer, and the procedure will interface
with design review, design change and document control. In procurement,
manufacture and installation, responsibility for addressing and completing
corrective action must always lie with functional management. The Quality
Assurance function is normally charged with co-ordinating and monitoring
action for system deficiencies.
4.14.3 Preventive action
Guidance
In addition to actions taken to correct a nonconformance and prevent recur-
rence, the Standard requires actions to prevent nonconformance arising.
Documentation should include procedures to review activities and products, to
specify responsibilities, to investigate and specify preventive action, and to
monitor the effectiveness of the actions. The outcome of preventive action should
be referred for management review at the appropriate level (see Section 4.1.3
Management review, page 10).
Adviso y procedures
Company and department procedures assign functional responsibility for the
collection, collation and review of quality related data. They specify data types
and include items specified in 4.14.3 (a) of the Standard. The procedures should
provide for continuous quality improvement through ongoing systematic elimi-
nation of causes of nonconformance. The activity interfaces of specified actions
should be monitored in a similar manner to those in Section 4.14.2.
The Standard requires the appropriate management level to review noncon-
formance and the effectiveness of preventive and corrective action.
Method statements for the control of installation and commissioning should
speclfy the data to be gathered, analysis to be conducted - for example,
statistical analysis - and the review bodies responsible for control. These may
be either in the Quality Manual or the Quality Plan.
Corrective action procedures and work instruction should establish:
clear reporting relationships;
individual accountability;
training and resource levels;
records, communication and feedback;
maintenance and revision of company standards;
document control.
4.15 Handling, storage, packaging and delive y
4.15.1 General
Guidance
The requirement applies to all engineering raw materials, work in progress,
fabricated, machined or sub-assembled components, together with fabricated or
proprietary items of process equipment.
It also relates to procedures for onsite and off-site operations including delivery
to the final destination. These may be general procedures or more detailed
instructions for specific or delicate items of equipment.
4.15.2 Handling
Guidance
This requirement relates to the handling of material, components and equipment
specified in the design, procurement and installation of the process plant. The
handling of plant and equipment is also part of the delivery processand therefore
Section 4.15.6, page 63, should also be referred to.
Adviso y procedures
Handling procedures should ensure that tolerances are maintained, physical
damage is avoided and the ultimate plant integrity is preserved. Different
procedures must be issued depending on the material, sub-component or item
of equipment being handled. Plant handling procedures will contain specific
reference to safe working practices.
4.15.3 Storage
Guidance
The storage environment needed for the various types of materials, components
and individual items of plant requires an assessment to determine the effect
during storage of temperature, humidity, dust and the potential for physical
damage. Storage areas will vary widely between construction sites, from those
open to inclement weather, to strictly controlled air conditioned rooms. There-
fore every application will have to be considered individually and designated
accordingly.
Adviso y procedures
Storage areas should be secure from vandalism and theft. Electrical equipment
may need to be stored under cover, machined parts greased and bearings
lubricated, etc. Process equipment supplied containing chemicals- for example,
refrigeration plant or packed bed dryers - and fragile control equipment and
instrumentation, will require special attention. Storage must take account of the
requirements of Sections 4.13.1 and 4.14 such that adequate space is available for
the separation of nonconforming material and equipment.
The Quality Plan (see Section 4.2 Quality system, page 12) will specify under
what conditions various plant and equipment should be stored. Care must be
exercised to ensure precise demarcation of similar materials - for example,
pipework. All materials and individual items of equipment must be clearly
identified with project tags to meet the requirements of product identification
and traceability (see Section 4.8, page 40). This should enable them to be easily
related to the components on the P&IDs or general arrangement drawings. Any
issue from stores must be clearly identifiable to the original order, as required in
Section 4.7.
4.1 5.4 Packaging
Guidance
The complexity, value, susceptibility to damage or deterioration of a component
will determine the quality and degree of packaging. Flange faces will require
minimum protection by the application of simple plastic covers, whereas vessels
shafts may require the temporary fixing of timbers to prevent distortion during
transit.
Advisory procedures
All materials, sub-assemblies and equipment items must be packed, supported,
strengthened and protected prior to dispatch, to ensure the components' integ-
rity is maintained and damage is prevented during handling, transit and storage.
This requirement must form part of the specification for the supply of all material
and equipment. Packaging procedures must be written to ensure that the quality
of the materials and equipment is maintained.
All equipment should be marked in accordance with tagging procedures. Sub-
contractors should supply equipment and components in accordance with the
numbering specified at the design stage. This will enable components after
inspection on receipt to be segregated to assist with the flow of materials during
installation.
Related written procedures will include:
marking;
equipment asset numbering;
pipeline identification;
inspection on receipt.
4.1 5.5 Preservation
Guidance
Major plant items will require adequate protection during transportation. For
example, stainless steel vessels should never be shipped as deck cargo without
adequate protection from sea spray. Similarly, components for critical applica-
tions may require special preservation procedures, an example being pipework
for biological processes which may need to be sealed in plastic at the factory to
avoid any form of contamination.
Besides procedures for plant, components and equipment, the installation phase
of the project may require specific preservation procedures to be applied. As
plant is installed, other nearby areas of the construction site could be susceptible
to contamination or damage and must be protected. This is of particular impor-
tance where process plant is being installed alongside an existing facility. Usually
production must be maintained and procedures enforced to ensure that the plant
expansion does not impact on the existing manufacturing capability and, most
importantly, product quality. To achieve this temporary facilities are usually
installed to specific requirements to ensure this integrity is maintained throughout
the installation period.
A further consideration with regard to preservation is to ensure the installed
plant is ready for commissioning. A typical example would be the passivation
of critical stainless steel surfaces wher procedures should ensure that spent
solutions are handled and disposed of safely. Passivation may take place either
at the suppliers' premises or in situ and procedures prepared accordingly.
Adviso y procedures
Procedures for preservation will cover those required for the protection of the
equipment from manufacture to installation. This would include surface coating
finishes for both temporary and long term protection. The requirements for the
plant protection will have been specified at the design phase (Section 4.4 Design
control, page 16). However, preservation will not be confined to surface finishes
alone and will include the following procedures:
cleaning/degreasing;
surface preparation;
painting;
passivation.
4.15.6 Delive y
Guidance
Most process plant projects are site erected and it is therefore inappropriate to
consider the delivery of the completed plant as an entity. It is the delivery of the
individual components which is the controlling factor. Basic components which
are relatively small can be delivered to site and placed in stores after final
inspection and test either on site or at the sub-contractor(s) works. Larger items
of plant such as distillation columns, large vessels and glass lined equipment, will
have special delivery requirements and these must be considered individually.
If late delivery of a single item of equipment could delay process commissioning,
then it may demand special delivery arrangements. Most equipment will be
delivered by road, although air, rail or sea freight may be considered depending
on the site location. Wide or long loads transported by road must have the
necessary escorts. Height and width restrictions along the route must also be
considered and, in certain circumstances, could influence the physical dimen-
sions of large items of plant at the design stage.
When large plant items are delivered to site they will require off-loading and
landing within a structure or on foundations. The delivery of these major plant
items to their final location will require specialist handling skills and will need
cranage on-site. Procedures should exist to ensure that plant is aligned and
installed as per design, before cranes are released.
The timing and co-ordination of plant and equipment delivery is critical during
the installation phase of the project, and the suppliers must ensure that every
component arrives on time on site according to the project co-ordination
procedure.
Adviso y procedures
For the delivery of plant to site, clear instructions as to the exact location of the
equipment are essential. Therefore, delivery instructions should be explicit and
are usually stated on the purchase order.
Rigging, slings and chains must be available and need to be checked regularly.
A register is required to demonstrate that rigging slings and chains have been
inspected on a periodic basis to comply with safey legislation.
A common source of post-delivery problems is the failure to remove packing
materials from plant and components. Perhaps.the most frequent omission is the
removal of plastic inserts from valves and pipework. Procedures should be in
place to check this point.
The procedures that must be considered for the delivery of plant and equipment
are:
off-loading;
safety procedures for plant erection;
storage and handling;
dispatch and receiving notes;
scaffolding;
rigging sling and chain inspection register;
plant alignment and inspection;
removal of packaging materials.
4.16 Control of quality records
Guidance
Quality records do not just arise, they have to be planned. Consideration must
be given at design, procurement, inspection, testing, construction, commissioning
and validation stages to ensure the records are established. This may be done
within the overall Quality Plan for the Inspection and Test Plans (ITPs).
Inspection and test records are important for validation. They also provide a
reference against which later performance can be compared. All the inspection
and test results (or the IQ, OQ and PQ documentation - see Section 4.4.8, page
28) must be carefully archived and easily retrieved for the system to be of benefit
(see Section 4.5.2(c) Document and data approval and issue, page 30). For some
regulatory bodies, it is important to demonstrate document retrieval within
predetermined times.
Quality records will have been maintained as a result of compliance with other
sections within the Standard (see Section 4.10.5 Inspection and test records, page
51).
Records of design drawings, documents or calculations may be held on electronic
files or as hard copy. Consideration should be given to the storage of critical
documentation in duplicate at different locations in case of loss due to fire, flood
or theft.
Advisory procedures
A design dossier should be collated with all the approved material certificates,
quality related documentation, letters of conformity and test certificates which
will be given to the customer at handover of the plant. This dossier will establish
the 'pedigree' of the plant and will be used for future plant maintenance and
inspection schedules. It also provides the objective evidence to auditors, third
party assessors and to the customer of compliance with the Quality Assurance
system and product specification.
4.1 7 Internal quality audits
Guidance
Audit of the quality system against the requirements of the Standard is manda-
tory and will cover quality planning.
There are four essential elements to an audit:
(i) an audit schedule;
(ii) a team trained in auditing techniques;
(iii) a formal audit procedure with properly documented records of audit results;
(iv) a corrective action, management review and follow-up procedure.
These are considered in turn:
(i) The audit schedule
A schedule should be prepared of frequencies for auditing each of the docu-
mented activities comprising the total process plant quality system. This will take
into account the importance of each part of the system to ensure that quality is
maintained. This would then be used to construct an annual programme as the
basis for planning the availability of appropriate auditors and to provide docu-
mentary evidence of the audit plan.
(ii) Training for effective auditing
To be effective, persons carrying out the auditing process must be trained in the
various techniques available. Before a training programme is set up, it is advis-
able to develop a clear idea of how the auditing is to be carried out - that is, by
one person, several individuals operating singly, by pairs or by teams. The
complexity and extent of the quality system and the number of staff available
will determine how many auditors it is practicable to use, bearing in mind the
requirement that they must be independent of the activity they audit.
It is essential to have a team trained in auditing techniques selected from staff in
different sections of the design, procurement, construction and commissioning
departments. This helps to identify interdepartmental difficulties and may sug-
gest alternative solutions.
(iii) Audit procedure
The auditing procedure is best formalized into a check-list of items to be
considered in each audit, but adapted by the auditors to suit the particular
activity to be audited. This is often done in a pre-audit meeting. It is important
to keep notes taken during the audit to record compliance or otherwise with the
procedures and suggestions for future corrective action. Note it is not sufficient
simply to record discrepancies; compliancies must also be recorded. An essential
part of the procedure must be to check that discrepancies identified on previous
audits have in fad been corrected and put into effective practice.
(iv) Corrective action and follow-up
The whole purpose of an audit is to establish that the quality system is being
implemented as described in the Quality Manual and the Quality Plan. Where
this is not found to be so, corrective action must be taken to ensure the fault is
removed and does not recur (see Section 4.14 Corrective and preventive action,
page 58). The follow-up action and date by which the fault must be put right
must be recorded; the period allowed will depend on how serious the discrep
ancy is.
It is important to state who is responsible for carrying out the corrective actions
and for following up any suggestions for improvement, along with target dates
for completion. Generally, responsibility for these rests with the departmental
manager or section leader of the activity audited. Subsequent management
reviews must check that the follow-up action has been done and is effective.
Advisory procedures
Auditing is an essential technique to be used in every element of any quality
system. To gain the most benefit from auditing, it must be seen as a tool or
technique for improving and developing the system from experience of its
operation and to keep abreast of changes.
Unfortunately, auditing is too often regarded as a policing and monitoring
procedure. This can be threatening to the managers implementing the system
under scrutiny. Thus, to be effective, auditors need to adopt a positive, helpful
and constructive attitude to audits to demonstrate their willingness to suggest
improvements and to give credit where systems are working well. This is in
addition to their normal role of establishing that the quality system is being
implemented as described in the documented procedures.
Applied in this manner to the procedures outlined in this guide, auditing will
consolidate and develop a sound system aimed at 'getting it right first time' and
a much safer and less stressful commissioning phase will be the reward.
Although not a requirement of IS0 9001, a good audit will also look for:
potential improvements in the quality system;
simplification of procedures without loss of effectiveness;
ways of reducing potential overlap, contradictions or gaps in procedures
interfacing with other departments.
A good auditing procedure should become an unobtrusive and helpful activity
welcomed by managers committed to the principles of Quality Assurance and
Total Quality Management. Implemented effectively, it will increase safety and
reduce risks and costly errors in the most complex projects. It will also result in
increased confidence and morale in the design function and lead to more satisfied
customers, whether internal or external.
4.18 Training
Guidance
Procedures are required to specify the means and responsibility for reviewing
and planning training needs to ensure that the design, procurement, manufac-
ture, construction and commissioning of a process plant project are carried out
by skilled, competent individuals for all activities.
Procedures are required to idenhfy all activities and the level of skill, experience
and knowledge needed to perform them satisfactorily and to define and provide
the necessary training. Adequate records of such training must be maintained
and documented.
Adviso y procedures
A comprehensive procedure, including job descriptions and performance a p
praisals by direct managers of each employee, has been found to be effective. Job
descriptions should include minimum educational requirements and experience
for each post. A training plan for each new employee is recommended which
should be specific to the individual concerned. This is particularly important
where special skills are require - for example, leading a Hazop study team.
Competence should be established wherever appropriate by examination, test-
ing or certification. Continual assessment is maintained by performance apprais-
als. Analysis of complaints and nonconformance may identify poor
workmanship as a cause, arising from lack of training, or loss of an unpractised
skill. In such cases a training need may be identified in the corrective action.
Records of training audits, appraisals, training courses and competence testing
must be kept and maintained.
4.19 Servicing
Guidance
Where proprietary equipment of a specialized design or application is specified
which requires specialist skills to maintain its safety, reliability, performance and
integrity, a maintenance contract with the manufacturer may be specified in the
main contract. Where this is so, the supplier (contractor/subcontractor) must
ensure that the servicing is carried out to specified criteria and procedures. This
will include frequency of servicing and the checks to be made at each service.
Records will be kept of faults found, corrective actions taken and further checks
needed, if any. Equipment which falls into this category may include refrigera-
tion packages, scrubbers, cooling towers, compressors, emergency generators
and water treatment services.
Where critical items of equipment are duplicated by installed spares or standby
equipment, it is essential that adequate procedures are in place for running them
periodically, testing and servicing them.
Adviso y procedures
In the cases described above it is necessary for the design engineers to specify
which equipment is covered by servicing contracts and to inform operational
and maintenance staff. Data should be provided and training given so that early
detection of a potentially serious breakdown can be made by operators or
craftsmen.
The procedures which must be considered are:
service arrangement and frequency;
maintenance records;
corrective actions and changes;
testing and servicing.
4.20 Statistical techniques
4.20.1 Identification of need
Guidance
The application of statistical control techniques are more appropriate to the
products manufactured by the process plant rather than the plant itself.
Statistical data taken from previous process plant installations producing similar
products may be a good basis for predicting the performance of a new installa-
tion. This could be achieved by defining the process capabilities of any new plant
in terms of data gathered. Once the process has been commissioned, the opera-
tional data which has been gathered can be analysed to determine the plant's
overall production capability and its optimum performance. This information
can then be used to assist in the design of subsequent process installations such
that the overall capital and operating costs may be minimized without affecting
the product quality.
In addition, it is possible to undertake a statistical analysis of components which
are used in bulk during the installation phase of the project - for example,
electrical clips and bolts. Statistical techniques can be used to establish a sensible
sampling plan (IS0 ~859) ' ~ for items of incoming material as part of the inspec-
tion procedure and for determining calibration intervals for measuring instru-
ments. The supplier of these components can then offer a guarantee of quality
by quoting their own sampling and inspection schemes.
4.20.2 Procedures
Guidance
Apart from the points made in Section 4.20.1, statistical control techniques are
more appropriate to the production output from the process plant, rather than
the activities associated with its design and construction.
Text references
1. BS5750 Part 0, IS0 9000,1979, Quality systems: Principles, Concepts and
Applications, Section 0.1 1987 Guide to the selection and use (British Standards
Institution).
2. CIA, 1987, BS 5750: Guidelines for Use by the Chemical Industry (Chemical
Industries Association, London).
3. CEFIC, 1991, EN29001 , IS0 9001: Guidelines for Use by the Chemical Industry
(CEFIC, Brussels).
4. BS 5750 Part 1, IS0 9001, 1987, Specification for DesigrdDevelopment,
Production, Installation and Servicing (British Standards Institution).
5. BS5750 Part 2, IS0 9002,1987, Specification for Production and Installation
(British Standards Institution).
6. BS 5750 Part 3, IS0 9003,1987, Specification for Final Inspection and Test
(British Standards Institution).
7. IS0 9001: 1994, Quality Systems - Model for Quality Assurance in Design,
Development, Production, Installation And Servicing. Also known as BS EN IS0
9001: 1994, formerly BS 5750: Part 1.
8. BSI Quality AssuranceGuide to the 1994Revision of BS 5750, IS09000 (British
Standards Institution). Available from BSI at address on page 70. Please quote
reference PR 123 when ordering.
9. Model Form of Conditions of Contract for Process Plant Suitable for Lump Sum
Contracts (The Red Book), 1995 (IChemE, Rugby).
10.
Model Form of Conditions of ContractforProcessPlant Suitab1efm:Reimbursuble
Contracts (The Green Book), 1992 (IChemE, Rugby).
11. BS 4778, IS0 8402,1987, Quality Vocabulary (British Standards Institution).
12. IS0 9000-3: 1991, Quality Management and Quality Assurance Standards
Part 3: Guidelines for the application of IS0 9001 to the development supply and
maintenance of software.
13. 'TicklT' Guide to Software Quality Management System, Construction and
Certification using IS0 9001/EN 29001/BS 5750 Part 1,1992 (Department of Trade
and Industry). This publication includes IS0 9000-3.
14. Horsley, D.M.C. and Parkinson, J.S., 1990, Process Plant Commissioning
(IChemE, Rugby).
15. IS0 10012: 1992, Quality Assurance Requirements for Measuring Equip
ment, Partl. Identical to BS 5781 Part 1,1992 (British Standards Institution).
16. IS0 2859-1: 1989, BS 6001: Part 1: 1991, Specification for Sampling Plans
Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
British and International Standards are available from:
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