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API SPEC Q1 / ISO TS 29001 :2007

Specification for Quality Programs for Petroleum,


Petrochemical and Natural Gas Industry

AWARENESS
PRESENTATION
AGENDA

 Introduction to API SPEC Q1 / ISO TS 29001

 Brief description of the various clauses of API SPEC Q1


requirements other than ISO 9001:2008
(Mentioned as Supplemental)

 API Monogram
Purpose of this program

 To understand the API SPEC Q1 standard with respect to our


organization
 To understand how these requirements can be fulfilled using
process approach
 To understand API Monogram, and why API Monogram is
required for our product
What is API Specification Q1 ?

 Quality management system requirements

 API Spec Q1 is developed and maintained by


petroleum industry professionals for petroleum
industry professionals

 API Spec Q1 is maintained by an API Quality


Committee which consists of international oil company
professionals, equipment manufacturers, quality
system auditors, service companies and API
equipment and quality professionals
API Specification Q1

 API Spec Q1, 8th Edition = ISO/TS 29001, + Annex A

 Standard specifies requirements for Quality Management


Systems for the petrochemical, oil and natural gas industry

 Annex A specifies requirements for the API Monogram Program

 API Spec Q1 Registration allows Monogram Licensees to


demonstrate that their quality systems are fully implemented
across a wide range of company operations

 Not just limited to:

–The manufacturing of API specification products or

–API Monogrammed products


API Specification Q1

 API Spec Q1 complements ISO 9001, but API Spec Q1 has


additional requirements that promote continual
improvement and product conformance through:

 Increased controls

 Emphasizing defect prevention

 Reducing variation

 Reducing waste

 Additional controls added through (41) additional


requirements specific to the above operational quality
initiatives
INTRODUCTION

 The adoption of Quality Management System should be a strategic


decision of an organization.
 The Quality Management System requirements specified in this
international standard are complementary to requirements for
products.
 This standard is used by internal and external parties, including
certification bodies, to assess the organization’s ability to meet
customer, regulatory and the organization’s own requirements.
 The Quality Management principles stated in ISO 9000 and ISO
9004 have been taken into consideration during the development of
this international standard.
Main Clauses
 4.0 - Quality Management System
 5.0 - Management Responsibility
 6.0 – Resource Management
 7.0 – Product Realization
 8.0 – Measurement Analysis & Improvement
 Annex A – API Monogram Program Requirements
Process Approach
This international standard promotes the adoption of a process
approach when developing, implementing and improving the
effectiveness of a Quality Management System.

For an organization to function effectively, it has to identify and


manage numerous linked activities.

An activity using resources and manage in order to enable the


transformation of inputs into outputs. Which is considered a process

The application of a system of processes within an organization,


together with the identification and interaction of these processes and
their management is referred to the “PROCESS APPROACH”
Process Based Quality Management System

Customer
Focus
Leadership
Quality Management Principles

 Customer Focus
 Leadership
 Involvement of People
 Process Approach
 System Approach
 Continual Improvement
 Factual approach to Decision Making
 Mutually Beneficial supplier Relationships
4 Main Clauses
These eight principles manifest themselves through the four
main clauses of :
MANAGEMENT RESPONSIBILITY – defining requirements
RESOURCE MANAGEMENT – determine and establish
necessary resources
PRODUCT REALIZATION – establish and implement
processes
MEASUREMENT, ANALYSIS AND IMPROVEMENT –of results
These are supported by the clause related to Documentation &
Records.
These main clauses are structured around the plan-do-check-
act cycle and contain a number of individual sub-clauses
Processes (activities) in an organization

Typical business processes in an industry :


 Purchase & Stores
 QA/QC

 Operations & Maintenance


 Planning
 Marketing
 HCGA
 Logistic
 CPCM
 Shipping
Types of processes
Customer Oriented Process (COP):
Any process that comes in direct contact with the
product that is delivered to a Customer, either first
level or second level. E.g. Forming, Welding, Coating
Support Process(SOP):
All Service Processes and Processes that support
COPs. E.g.- HR, Maintenance, Purchase
Management Process (MP):
All such processes which establish the quality
policy , objectives and goals, provide necessary and
adequate resources and actions to achieve the same.
E.g. – MRM, Internal & External Audits
Process approach

Systematic identification and management of the


various processes employed within an organization,

AND PARTICULARLY

The interactions between such processes is referred to


as the process approach to management
Process approach

All well-defined and well-managed processes have


common characteristics:
A well-defined team with a leader is held accountable
for how well the process performs (the process owner)
Well defined boundaries (the process scope)
Well defined interfaces and responsibilities
Well documented procedures, work instructions and
training
Well defined measurement and feedback controls
Customer related measurements and targets
Well known cycle times
QMS - BASICS

ACTION ELEMENTS FOR QUALITY MANAGEMENT SYSTEM


IS BASED ON 5 KEY CLAUSES

CLAUSES NO. 4 TO 8
QMS - BASICS

5 KEY CLAUSES CAN BE DIVIDED INTO

SYSTEM BASED : OPERATIONAL


CLAUSES (PRODUCT CENTERED):
4, 5 AND 6 CLAUSES 7 AND 8
System based elements
4.0 Quality Management 4.1 General requirements
System 4.2 Documentation requirements

5.0 Management Responsibility 5.1 Management Commitment


5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, Authority and
Communication
5.6 Management Review

6.0 Resource Management 6.1 Provision of resources


6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
Business Operations based elements

7.0 Product realization 7.1 Planning of Product realization


7.2 Customer related Processes
7.3 Design and Development
7.4 Purchasing
7.5 Product and Service Provision
7.6 Control of Monitoring and
measuring devices.

8.0 Measurement, 8.1 General


analysis and 8.2 Monitoring and Measurement
8.3 Control of Non-Conforming Product
improvement 8.4 Analysis of Data
8.5 Improvement
Clause 4 – Quality Management
System

4.1 General Requirements

4.2 Documentation
Requirements

4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
Clause 5

5. Management Responsibility

Consists of :
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, Authority
and communications
5.6 Management Review
Quality system vocabulary -
Terms & definitions

QUALITY PLANNING
Objectives can be set as a smart
goal
SMART means…
S PECIFIC
M EASURABLE
A SSIGNABLE
R EALISTIC
T IME BOUND
Clause 6

6 Resource Management

 Consists of 4 sub-elements

6.1 Provision of resources

6.2 Human Resources

6.3 Infrastructure

6.4 Work Environment


Clause 6.2

6.2 Human Resources


6.2.2 Competence, Awareness and Training
The organization shall:
a) determine the necessary competence for personnel
performing work affecting product quality;
b) Provide training to satisfy these needs;
c) Evaluate the effectiveness of the training provided;
d) Ensure that its personnel are aware of the relevance and
importance of their activities and how they contribute to
the achievement of the quality objectives;
e) Maintain appropriate records of education, training, skills
and experience ( see 4.2. 4)
Competence & Training (Section 6.2)
Process Approach
Clause 7

7. Product realization

 Consists of 6 sub-elements

7.1 Planning for Product Realization


7.2 Customer Related Processes
7.3 Design And Development
7.4 Purchasing
7.5 Production and Service Provision
7.6 Control of monitoring and measuring devices
Clause 8

8 Measurement , Analysis and Improvement

Consists of 5 sub elements

8.1 General

8.2 Monitoring and Measurement

8.3 Control of Nonconforming product

8.4 Analysis of Data

8.5 Improvement
Clause 8.1

8.1 General

The organization shall plan and implement the monitoring


measurement, analysis and improvement process needed
a) To demonstrate conformity of the product
b) To ensure conformity of the quality management system,
c) To continually improve the effectiveness of the quality
management system
This shall include determination of applicable methods, including
statistical techniques, and the extent of their use.
Clause 8.3
8.3 Control of Nonconforming product
 Ensure that product which does not conform to product
requirements is identified and controlled to prevent its
unintended use or delivery.
 The controls and related responsibilities and authorities for
dealing with nonconforming product shall be defined in a
DOCUMENTED
PROCEDURE.
The organization shall deal with nonconforming product by one
or more of the following ways:
a) By taking action to eliminate the detected nonconformity;
b) By authorizing its use, release or acceptance under
concession by a relevant authority and, where applicable,
by the customer;
c) By taking action to preclude its original intended use or
application.
Clause 8.3

Records of the nature of non-conformities and any subsequent actions


taken, including concessions obtained, shall be maintained.

When nonconforming product is corrected it shall be subject to re-


verification
to demonstrate conformity to the requirements

When nonconforming product is detected after delivery or use has


started ,
the organization shall take action appropriate to the effects, or
potential
effects, of the non conformity.
Clause 8.4

8.4 Analysis of Data


The organization shall determine, collect and analyze
appropriate data
to demonstrate the suitability and effectiveness of the quality
management system .
To evaluate where continual improvement of the effectiveness of
the
quality management system can be made. This shall include
data
generated as a result of monitoring and measurement and from
OTHER RELEVANT SOURCES.
Other Relevant sources

OTHER RELEVANT SOURCES:


• Management Review
• Staff / Employees
• Design & development of products
• Performance of products
• Customers & other interested parties i.e. surveys or complaints
• NC products
• Audit outputs

MAIN FOCUS –> ASSESS – CONTROL - IMPROVE


Clause 8.4
The analysis of data shall provide information relating to:

a) Customer satisfaction

b) Conformance to product requirements

c) Characteristics and trends of processes and products including


opportunities for preventive action, and

d) Suppliers
Clause 8.5

8.5 Improvement

Consists of 3 sub elements

8.5.1 Continual Improvement

8.5.2 Corrective Actions

8.5.3 Preventive Actions


Clause 8.5.1

8.5.1 Continual Improvement


The organization shall continually improve the effectiveness of
the quality management system through the use of
 Quality policy,
 Quality objectives,
 Audit results
 Analysis of data,
 Corrective and preventive actions
 Management review.
Clause 8.5.2

8.5.2 Corrective Actions


The organization shall take action to eliminate the cause of
nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the
nonconformities encountered.
A DOCUMENTED PROCEDURE for corrective action shall be
established to define requirements for:
Reviewing nonconformities (including customer complaints)
Determine the causes of nonconformities
Ensure that nonconformities do not recur
Determining and implementing the action needed
Records of the results of action taken
Reviewing corrective action taken.
Clause 8.5.3
8.5.3 Preventive Actions
A DOCUMENTED PROCEDURE shall be established to
define requirements for:
a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of
nonconformities
c) determining and implementing action needed
d) records of results of action taken
e) reviewing of preventive action taken\
THESE SHOULD IDEALLY GIVE RISE TO CHANGE IN
PROCEDURES !
Annex A –License Requirements

 When specified, Licensee must comply with API Spec Q1,


including Annex A

 When specified, Licensee must meet all requirements of the


Product Specification

 When specified, Licensee must comply with License


Agreement

 When specified, Licensee must apply the API Monogram


products in accordance with Annex A
What Does the API Monogram Mean?

 Licensee warrants that product meets Product


Specification in every detail

 Licensee activities conform to all Quality Management


System requirements

 Licensee can only apply the API Monogram on products


for which they have the license

 Capable manufacturer

 Licensee has made a commitment to the industry to


improve
What does the Monogram Mark Mean?

 Licensee’s QMS is compliant with API Spec Q1

 Licensee has the technical capability to meet API Product


Specification requirements

 Licensee has entered into a warrantee with the purchaser,


meaning that products meet the API requirements

 Only apply to conforming products

 Licensee can only apply the API Monogram on products for


which they have the license

 Capable manufacturer
The API Monogram / Certification
The Power of the Program

 Licensees meet QMS requirements

 Licensees must meet specification requirements developed by


industry

3 Essential Elements

 Quality System conformance to API Specification Q1

 Conformance to one or more API Product Specifications

 A License Agreement / Program Requirements


Use of the Monogram Mark

 Applied only by licensee at the licensed facility

 Applied only when API Spec Q1 & API Product Spec


is met

 Must include License number and date of


manufacture

 Can be applied at any time during the manufacturing


process, but must be removed if product is found to
be non-conforming
API Monogram Licensing Process
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