Iso Sustainability

QUALITY RESOURCE CENTER, INC.
ISO 9001
Managing for Sustainability (408) 451-8413
1703051A
The draft changes to ISO 9001 and ISO 9004 for 2008
Draft ISO 9001: Requirements Standard
Minor changes for clarification and compatibility with ISO 14001. Even small changes to the Standard can dramatically impact a users QMS.
Draft ISO 9004:
Guidelines document
A major revision, with a focus on providing guidance on organizational sustainability rather than performance improvement.
2703051A
Draft ISO 9004:

Definitions
Managing for Sustainability
Sustainability of an organization: Ability of an organization or activity to maintain or develop its performance in the long term.
3703051A
Draft ISO 9004:
Sustainability Issues
4. Managing for sustainability 5. The organization's environment 6. Strategy policies and communication 7. Resources 8. Processes 9. Measurement and analysis 10. Learning, improvement and innovation A. Maturity Assessment
4703051A
Topics for our discussions that are relevant to ISO 9004

Company focused documentation Service Level Agreements Controlling processes Risk reporting Self Assessments of System Maturity
5703051A
Relevance to the ISO 9004 draft

4. Managing for sustainability 5. Organization's environment 6. Strategy policies and communication 7. Resources 8. Processes 9. Measurement and Analysis 10. Learning, improvement, innovation A. Maturity assessments Company documentation Company documentation Company documentation Service Level Agreements Sustainability of processes Service Level Agreements Risk reporting Self assessments
6703051A
Some organizations that have worked with these methods

NYK Logistics Point Technologies Delta Faucet FAA (NSP) FAA Academy TMX Aerospace Marvell Department of Energy Hitachi Lucent BSI Services SDC Toshiba Covanta Energy Iron Systems Chugach Industries Future Technologies KSEC Quantum 3D Logistics 2020 Total Resources International Interconex Sensor Platforms A & E Anodizing Delphon Sensarray Sigma Design Airfield Technology Kenergy
7703051A
Sustainability
8703051A
Traditional documentation method: The Pyramid

ISO 9000 Standards QUALITY POLICY MANUAL (Level One)
QPM
Management Policies Reference QOP
QUALITY OPERATING PROCEDURES (Level Two)
How Managements Policies are implemented (Who, when, how) Reference
PROCESS FLOWS (Level Three)
WORK INSTRUCTIONS (PROCESS) Descriptions of processes in operation where people work Reference OTHER INSTRUCTIONS AND SPECIFICATIONS (TASK) (Technical Specs.; Standards; Job Descriptions etc.)
9703051A
The impact of the Pyramid

Useful for documenting Element based ISO Systems since 1987 Easy for an ISO specialist to audit Not so easy for a Manager to identify with Loads of templates A reason why ISO Quality Management Systems were identified primarily with the Standard and not the companys operation Helped ISO 9000s reputation for creating a bureaucracy Give a perception of specialized ISO documents
Managing for Sustainability (408) 451-8413 10703051A
ISO 9001:2000
Documentation Checklist
The amount of documentation is determined by: Type and size of organization Complexity and interaction of processes Competence of personnel
Systems can be documented in a way that is appropriate and effective for the organization
(ISO 9001: 4.2.1 Note 2)
11703051A
ISO 9001:
What we document to be in compliance
The way the company's QMS addresses: Clause 4: Clause 5: Clause 6: Clause 7: Clause 8: Quality Management System Management Responsibility Resource Management Product Realization Measurement Analysis and Improvement
12703051A
Option 1:
Document the Clauses

QPM
Management Policies Reference QOP
ISO 9000 Standards QUALITY POLICY MANUAL (Level One)
QUALITY OPERATING PROCEDURES (Level Two)
How Managements Policies are implemented (Who, when, how) Reference
PROCESS FLOWS (Level Three)
WORK INSTRUCTIONS (PROCESS) Descriptions of processes in operation where people work Reference OTHER INSTRUCTIONS AND SPECIFICATIONS (TASK) (Technical Specs.; Standards; Job Descriptions etc.)
13703051A
Option 2: Focus on the company and not on Clauses

How does the company conduct Sales? How does the company control Design? How does the company meet product/service requirements? How does the company furnish resources? How does the company address required ISO procedures? How does the company encourage Management Commitment to the QMS?
14703051A
Mix what the company does with what ISO requires
se 6 .
M an a uf g rin ctu
Tr ain
Cla u
a Cl
us
. e5
1
C
se l au
7. 1 7. 3 lause C
les Sa
ing
De n sig
15703051A (408) 451-8413
Good for the Company; good for the Auditor
16703051A
Response to Company focused documentation

In the last few years, the following Certification bodies have provided written compliments to companies working for initial Certification by using company focused documentation:
BVQI BSI TUV Rhineland Orion
17703051A
Typical Company focused documents (Modules)
Management
Sales
Product Development
Operations
Resources
Management Representative
18703051A
The Management document

The Quality Manual is usually a document that engages the interest of the Certification Auditor more than Top Management The Management Commitment Module provides Top Management with one page summaries of their required commitment to each of the ISO 9001 Quality Management Principles (ISO 9000: 0.2) These summaries include Involvement activities Identification of documents and records A Checklist to evaluate the effectiveness (maturity) of the organization's activities
19703051A
ISO 9000: 0.2 Quality Management Principles

1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to Management 6. Continual improvement 7. Factual approach to decision making
Managing for Sustainability (408) 451-8413 20703051A
Content of operational focused documents

Policy Level
Summary of Services of the Department or Key Function Service Level Agreement
Strategy Level
Process criteria for: Inputs (process interactions with internal Suppliers) Outputs (process interactions with internal Customers) Goals (effectiveness in providing internal Customer satisfaction)
Tactical Level
List of process requirements
Evidence and Reference

List of Forms and Records List of Reference documents Revision History
21703051A (408) 451-8413
Example of Sales Department document

The Customer Relations Management Module provides policy, strategy and tactical information for the following activities: Customer focus Requirements related to product Review of requirements related to product Customer communication Monitoring and measuring customer satisfaction
22703051A
Typical Document Ownership

Dept. Module Process Requirements Job Aids
Quality Manual
Dept. Module
Process Requirements
Job Aids
Dept. Module Top Management Middle Management
Process Requirements
Job Aids
Supervisors
Employees
23703051A
Applicability to draft ISO 9004: Essential Features for Sustainability

1. Articulate a mission and vision Summary of Services Goals
2. Develop a Strategic Plan
Process inputs Process outputs Service Level Agreements
3. Realization of Strategic Plan
Process requirements Job Aids
24703051A
Sustainability
25703051A
A process network within a Department

Example of a Purchasing Department as an Internal Supplier
Select Supplier RFQ Operations Process RFQ Negotiate PO Deliverable Operations
Quality Dept.
Evaluate Supplied Product
26703051A
Processing a PO:
Usual problems
Typical Internal supplier dysfunctions:
o o o o o o Operate without a Purchase Req. Inadequate Supplier list Too willing to be flexible Unwilling to be flexible Using too many shortcuts Too busy
27703051A (408) 451-8413
Typical Internal customer dysfunctions:

No Purchase Requisition Unreasonable expectations Requests are too late Requests are badly defined Last minute changes Poor interactions
Example of Purchasing SLA:
Typical Objectives
Objectives of the Agreement Supplier (Purchasing) Objectives: a To purchase products according to the specifications of approved and agreed Purchase Requisitions b. To conduct these purchases in accordance with the requirements of current Purchasing processes and ISO 9001 specifications Customer (Operations) Expectations: a The availability, as required, of product specified in the approved and agreed Purchase Requisition
28703051A

Agreement Purchasing will:
Typical Agreement
a Review the Purchase Requisition for conformity with requirements (Process 3.1.1) b. Source the best Supplier (Process 3.1.2) c. Process the Purchase Order (Process 3.1.1) d. Arrange Incoming Inspection of purchased item (Process 3.2.4) e. Implement Corrective Actions for nonconforming product (Process 5.3.3)
Operations will:
a. Prepare a Purchase Requisition in accordance with process requirements (Process 3.1.1) b. Validate the received item against the specifications contained in the Purchase Requisition c. Segregate the item if nonconforming (Process 5.3.2) d. Promptly advise Purchasing of nonconforming product (Process 5.3.3)
29703051A
Document specifications
Forms, Records and Reference Documents By Purchasing

Modules 3 and 5
By Operations
Modules 3 and 5
Approved Vendor List
Purchase Requisition
Purchase Order
PCAR Form (if required)
Incoming Inspection Report
30703051A
Example of Purchasing SLA: Sample Measures of Success
The Measures of Success of the process are: a. Purchase Requisitions meet the requirements of Process 3.1.1 b. Purchased products satisfy the specifications of the Requestor c. Purchasing activities follow the requirements of the organizations processes and the ISO 9001 Standards d. Corrective Actions follow the requirements of the organizations processes and the ISO 9001 Standards e. There is appropriate evidence of activities
31703051A
Use of a Service Level Agreement

The Service Level Agreement (SLA) is between Purchasing and Operations
Select Supplier RFQ Operations Process RFQ Negotiate PO SLA Quality Dept. Evaluate Supplied Product Deliverable Operations
32703051A
Sustainability
33703051A
Usual problems with process integrity

Processes are constantly in danger because: Not audited frequently enough Audits not thorough enough Resistance from users Pressures built into the process Human nature The processes are originally badly thought out Have not reacted to changes Poor training of process users Poor documentation of the process
34703051A
The anatomy of a typical daily process Coffee Break
Step 1
Step 2
Step 3
Step 4
Coffee Time
Go to Canteen
Get coffee
Return to desk
A process is an orderly or established series of steps or operations toward a desired result or product
Websters Dictionary
35703051A
Pressures on the process by the process users
Step 1
Step 2
Step 3
Step 4
Coffee Time (Priorities)

Is this clock reliable? Do I want to interrupt what I am doing? Will that customer call while I am away from my desk? Managing for Sustainability
Go to Canteen (Time Allocation)

Will the Canteen be busy? What will my boss think if I am away from my desk for a long time? How much time can I spare?
Get coffee (Quality Issues)

Is this stuff fresh? Where is the cream? Has this cup been washed?
Return to desk (Consequences)

I missed that call Where did I put that letter? Who left this note?
36703051A (408) 451-8413
Sustaining the Process
Step 1
Step 2
Step 3
Step 4
Coffee Time (Priorities)

What are the objectives of the coffee break? Are these objectives being met by the present policies?
Go to Canteen (Resource Issues)

How many people can be served in the Canteen during the allotted coffee times? How many people want to use the canteen?
Get coffee (Quality Issues)
Return to desk (Risk prevention)
Who is responsible for Is there a back up system the quality of the coffee for people who leave their service? desks at coffee time? How are complaints dealt with? How many times has this back up been required?
37703051A
Sustaining the process through Process controls

Preventive
Controls that keep something bad from happening
As processes are developed, controls should be part of the development plan
Detective
Controls that monitor activities and processes to determine if preventive controls have failed and something is out of compliance
Corrective
Controls that restore a situation back to the expected state
38703051A
Examples of Preventive Controls

I/D 1 Department IT Objective Prevent unauthorized changes to controlled documents Prevent acceptance of job applicants who misrepresent their credentials Prevent Inspection equipment from giving wrong measurements Preventive Control Electronic signature approval process Application checking processes
HR
Manufacture
Using a golden measure as a check of accuracy at the beginning of each Shift
39703051A
Examples of Detective Controls

I/D 1 Department IT Objective Being sure that the signature authorization process cannot be circumvented Confirm that the information checking process is always used Making sure the golden measure is always used Detective Control Periodic tests of process safeguards
HR
Information Checking Log with date and signature Accuracy Test Log with date and signature
Manufacture
40703051A
Examples of Corrective Controls

I/D 1 Department IT Objective Recovering from system crash that loses signature authorization list Dealing with Checking Log that is not being consistently completed Making an effective response when the Test Log is not consistently completed Corrective Control Back-up data security process
HR
Require confirmation signature (separation of duty) Require confirmation signature (separation of duty)
Manufacture
41703051A
Consequences of controlling processes

Problem
Insufficient auditing o
Response
Provide preventive and detective controls Understand potential pressures on the process use during the process design Provide corrective controls
User resistance
Impact of changes
42703051A
Sustainability
43703051A
Reasons for Risk Reporting

Audit reports are often phrased in ISO terms: The Approved Vendor List has been established as an on-line database with suppliers qualified prior to 1 November 2006 being grandfathered. The one new supplier since November 2006, (XXXXX) was added to the AVL database in February 2007 even though the qualification was completed (final approval) on 10 April 2007. This is important to a Certification Auditor How important is it to a Department Manager?
44703051A
Usual Management reaction to a perceived ISO nonconformity

Scope:
Evaluate the calibration status of test equipment in the manufacturing area.
Findings:
Two test fixtures had not been calibrated as planned
Usual Management reaction:
Eight hours of a persons time to find out two labels were missing
45703051A
Setting up Risk Reporting
Process
Risk Reporting steps 1. Determine with the process owner and/or the process customer the potential consequences of not meeting the process goals Obtain management acceptance of consequences Document the consequences as part of the process (Detective Controls) Plans to avoid failure (and therefore the consequences) (Corrective Controls) are added
46703051A (408) 451-8413
2. 3. 4.
Risk Reporting the same findings

Findings:
Two test fixtures had not been calibrated as planned. The units were out of calibration. The process records indicate that: 5,000 parts have been delivered to our major customer that may be out of specification Consideration may need to be given to recalling these parts
Potential Management reaction:

Lets get this fixed straight away and see it doesnt happen again
47703051A
Risk Reporting addresses the Rules of Communication

The basic rules of communication are:
What is said may not be what is heard What is heard may not be what is understood What is understood may not be accepted
48703051A
Sustainability
49703051A
What draft ISO 9004 says about Sustainability and Assessment

Organizations should use an assessment tool --- to determine their maturity level, i.e. how well their essential capabilities are developing and growing towards the achievement of sustainability
The completion of an assessment should be recognized as an important step in identifying opportunities for future development of the organization
50703051A
An earlier Self-Assessment Tool:
SSQA
A 0 10 measure of the following categories Management Commitment (MC) Systems Approach (SA) Deployment (D) Results (R)
51703051A
Draft ISO 9004 Categories

Categories are measured by level of performance against the 31 Clauses of the draft ISO 9004 1. Beginner 2. Proactive 3. Flexible 4. Innovative 5. Sustainable
52703051A
A simpler approach
An Evaluation program that:
Can be applied to: All or part of the organization Any process Any System Can be conducted by people who work in or with the area being evaluated Can be an input to a more comprehensive evaluation system (e.g. Internal Audits)
53703051A (408) 451-8413
Evaluate any part of the business jigsaw as the need arises Evaluate activities that are critical or are suspect
Motivations for Evaluations

Typical motivations for Evaluations include:
Trends from Customer Audits, Internal Audits and Conformance Audits Customer complaints Increased customer returns Poor response to quotations Financial reports High people turnover Management vigilance Loss of market share Results of surveys Poor supply chain performance
54703051A
The findings of an Evaluation Assessment

Maturing
Developing towards a required standard of performance Inconsistent and wasteful, but getting better
Mature
Consistently achieving a required standard of performance and continuing to improve
Benefits the whole organization Replaces benefits with frustrations
Fossilized
Rigid, bureaucratic and unresponsive to the needs of the organization
55703051A
Assess typical stages in a Maturing System

Stage 1 Evidence No systematic approach, ineffective or no documentation, anecdotal understanding of requirements, poor or unpredictable results, no goals Limited systematic approach, some documentation that is intermittently used, reactive responses, limited data on effectiveness, informal goals Processes are defined, generally documented but intermittently followed, some performance information is being collected Processes exist, ownership is known and there is occasional improvement, documentation is mostly understood and used, goals are anecdotal, but, when known are being worked to A systematic, process based approach, some reviews and attempts at improvement, goals are known and performance measured, feedback is used for improvement
56703051A (408) 451-8413
3 4
Some assessments of a Maturing System

Management expectations are mostly known (policies and goals) Goals are not yet consistently realized There are informal programs to achieve goals Improvement activities are being worked on, but without urgency If controls do not exist, they are being developed, but unevenly Change is happening and the results are positive, though
unpredictable
Documentation is becoming a value added tool Needs and expectations of interested parties are increasingly
being responded to
Supplier relationships are improving
57703051A
Typical assessments of a Mature System

Criteria Stability Evidence Systematic, process based approach; objectives known; data is available on conformance to requirements ; stable and efficient workforce that is well trained and competent Improvement process in use, good results and sustained improvement trends Processes are controlled; there is evidence of prevention, detection and correction controls; interactions of processes are effective Benchmarking against best in class; close customer relationships that result in cooperative planning of future business Performance goals are planned, balanced with resources and regularly updated; results are consistent with goals, risks are quickly identified and dealt with
58703051A (408) 451-8413
Progress Control
Potential
Results
Some assessments of a Mature System

Management expectations are known (policies and goals) Management policies and goals are traceable throughout the objectives of each Key Function Objectives are being consistently met
Controls are in place and are protecting the company from

unexpected Organic Change
Improvements are coordinated to respond to changes in

managements policies and goals Needs and expectations of interested parties are considered and responded to in a balanced way Supplier relationships provide mutual benefits
59703051A
Typical assessments of a Fossilized System

Symptom Inflexible Evidence The system is disconnected from the needs of the organization and the requirements of customers; success is measured by conformance to the system, not the effectiveness of the system The system is over documented and many of the documents are not used People only follow the system as far as is needed to pass audits; there is no concern for improvement to the system New employees are not aware of the system; a system team deals with all inquiries regarding the system; when problems arise, the system is not part of the solution Actual performance requirements are primarily anecdotal; the system driven performance requirements are out of date
Bureaucratic Ineffective Ignored
Performance
60703051A
Some assessments of a Fossilized System
The quality management system is mostly disconnected from the activities of the operation There is an identified group that is known to own the system. This group only communicates with the rest of the organization in matters of failed compliance An external audit is the cause of disruption as evidence has to be
made ready
Management gives no consideration to the system in its strategic planning activities The perception is that the system is bureaucratic. There is a great deal of documentation, but little evidence that it is of benefit or being used, except for conformance purposes
61703051A
Sustainability
62703051A
Sustainability
Sustainability of an organization: Ability of an organization or activity to maintain or develop its performance in the long term. Sustainability can best be achieved by: o Addressing the requirements of ISO 9001 as improvements to the existing operation, not a paint by numbers rule book o Communicating requirements for change in the language of the organization, not the Standard o Changing the meaning of Say what you do and do what you say to set goals and achieve them.
63703051A

Iso Sustainability

Transféré par

Informations du document

Description originale:

Copyright

Formats disponibles

Partager ce document

Partager ou intégrer le document

Options de partage

Avez-vous trouvé ce document utile ?

Ce contenu est-il inapproprié ?

Droits d'auteur :

Formats disponibles

Iso Sustainability

Transféré par

Droits d'auteur :

Formats disponibles

QUALITY RESOURCE CENTER, INC.

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Draft ISO 9004:

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Draft ISO 9004:

Managing for Sustainability

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Draft ISO 9004:

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Topics for our discussions that are relevant to ISO 9004

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Relevance to the ISO 9004 draft

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Some organizations that have worked with these methods

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Traditional documentation method: The Pyramid

QUALITY OPERATING PROCEDURES (Level Two)

How Managements Policies are implemented (Who, when, how) Reference

PROCESS FLOWS (Level Three)

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

The impact of the Pyramid

QUALITY RESOURCE CENTER, INC.

(ISO 9001: 4.2.1 Note 2)

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

What we document to be in compliance

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Document the Clauses

ISO 9000 Standards QUALITY POLICY MANUAL (Level One)

QUALITY OPERATING PROCEDURES (Level Two)

How Managements Policies are implemented (Who, when, how) Reference

PROCESS FLOWS (Level Three)

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Option 2: Focus on the company and not on Clauses

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Mix what the company does with what ISO requires

15703051A (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Good for the Company; good for the Auditor

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Response to Company focused documentation

BVQI BSI TUV Rhineland Orion

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

Typical Company focused documents (Modules)

Managing for Sustainability (408) 451-8413

QUALITY RESOURCE CENTER, INC.

The Management document

Managing for Sustainability (408) 451-8413