5.7 Concomitance


5.7 Concomitance

Each SHALL denotes a specific requirement of the Standard. The requirements are often linked in such a way that they are associated (reciprocal, canonical) requirements. We have defined this associative characteristic of the clauses as concomitant relationships. As a result, if any one SHALL is not adequately addressed, there is an impact on other sections of the Standard because each SHALL is a part of the Standard's overall fabric.

As we have previously noted, each SHALL in the Standard is written to be descriptive with the intent that we are to reply in a prescriptive manner. By prescriptive, it is meant that the response includes operational details (e.g., what really happens, the actual method used, the specific approach taken in response to the requirement) but not the procedural details, unless you wish to produce an integrated manual that contains both policy and procedure. In either case, prescriptive statements are implied. In this way the manual can be used effectively by decision makers (e.g., customers who must decide on whether or not to audit their sub supplier based on a reading of the manual).

5.7.1 Requirement

Thus, the STANDARD's descriptive requirement, 4.1 General Requirements, might be responded to prescriptively as follows:

Example response: "4.1 General Requirements: David Wayne Environmental Systems (DWES) has established a quality management system (QMS) that conforms in detail to the ISO 9001:2000 International Standard (Standard). The QMS encompasses the eight quality management principles described in the Standard. Document control and maintenance of the QMS is provided by the Director of Quality Assurance. The ISO 9000 Steering Committee, comprised of DWES top management and invited management representatives, oversees the effectiveness of the QMS via monthly reviews of the system's performance metrics. The objective of the Steering Committee is to ensure continual QMS improvement through the use of Quality Action Teams (QATs) assigned to resolve business nonconformances based on quantitatively arrived at solutions."

5.7.2 Training Example of Concomitance

Let us assume that prescriptive quality policy statements are in use and now look at an example of this concomitant—or interelement—relationship.

Our first example concerns training that occurs as follows:

  • Explicitly in Clause 6.2: Human Resources;

  • In Clause 7.5.2 (b): Validation of Processes for Production and Service Provision, where it requires that we determine that personnel are adequately qualified for their positions;

  • In Clause 7.4.2 (b): Purchasing Information, where it requires specific training of the supplier's personnel when it makes sense to do so.

Training concomitance also occurs in the following ways:

  • Implicitly in Clause 4.1(d): General Requirements, as it relates to resource availability;

  • In Clause 5.1(e): Management Commitment, where again it refers to the resource availability;

  • In Clause 5.6.3(c): Review Output, in regard to the determination of needed resources;

  • Again in Clause 6.1: Provision of Resources, where we are required to decide on what level of resources are needed and then provide such resources.

Table 5.4, summarizes the various ways in which concomitance acts as a training binder throughout the requirements.

Table 5.4: Concomitant Training Relationships in Standard

Impact

Standard's Clauses

In That Clause We Are Required To...

Explicit

6.2 Human Resources

Indicate that all personnel performing work that affects product quality is competent on the basis of appropriate education, training, skills, and experience

Determine just what that competence level is to be

Provide for ways to support the competence needed

Evaluate the effectiveness of the program

Inform employees how they influence the attainment of quality objectives

Keep records of such activities

7.5.2(b) Validation of Processes for Production and Service Provision

Establish ways to validate special processes that includes the approval of equipment and the qualification of personnel

7.4.2(b) Purchasing Information

Instruct our suppliers in the need for any specific personnel qualification requirements

Implicit

4.1(d) General Requirements

Indicate how the organization ensures the availability of resources and information that is required to support the operation and monitoring of its processes

5.1(e) Management Commitment

Provide evidence of its commitment to the development and implementation of the QMS and to its role in continually improving QMS effectiveness by ensuring the availability of resources

5.6.3(c) Review Output

Include any decisions and actions related to resource needs

6.1 Provision of Resources

Determine and provide the resources needed to both implement and maintain the QMS and continually improve its effectiveness, and enhance customer satisfaction by meeting customer requirements

In each case, training is viewed from seven different, yet synergistic, perspectives:

  1. Explicitly, in Clause 6.2, we discuss training as a top-down enterprise strategic issue.

  2. Explicitly, in Clause 7.5.2(b), we consider the impact of training on the methods used to validate special processes (i.e., those that we cannot fully verify before the product is put into use by the customer).

  3. Explicitly, in Clause 7.4.2(b), the possible training requirements for our supplier's personnel are considered.

  4. Implicitly, in Clause 4.1(d), we again include training in an umbrella fashion to ensure that it is sufficient to successfully implement our processes.

  5. Implicitly, in Clause 5.1(e), we admonish top management that its role is to ensure that adequate training is available.

  6. Implicitly, in Clause 5.6.3(c), top management is again admonished to make sure that it checks on adequate training as part of management review.

  7. Implicitly, in Clause 6.1, we are required to clearly determine and provide the training needed to employ an effective and customer-oriented QMS.

A more general perspective can be gained if we look at the total set of clauses at a glance as summarized in Table 5.5. As we have demonstrated in the training concomitance example, this table indicates other cases where an element of the Standard either clearly or implicitly references another element. Two other direct references, for example, are as follows:

  1. When Clause 5.6: Management Review refers directly to Clause 4.2.4: Control of Records.

  2. Clause 5.4.2: Quality Management System Planning specifies that the requirements of Clause 4.1 are to be met.

Table 5.5: Standard's Concomitance at a Glance

Type of Concomitance

Key Issue Involved

Explicit (Sent Directly to Clause)

Implicit (Implied Associated Clauses)

No. of Link(s)

ISO Clauses (1994)

4.0 Quality management system

4.1(a) General requirements-QMS (4.2.1)

Process(es) scope,exclusion

1.2

7.1(b), 7.5.2, 7.6, 8.1, 8.2.2, 8.2.3

7

4.1(b) General requirements-QMS (4.2.1)

Process interact

4.2.2(c)

1

4.1(c) General requirements-QMS (4.2.1)

Effectiveness

5.6.1, 6.1(a), 8.4, 8.5.1

4

4.1(d) General requirements-QMS (4.2.1)

Resources

6.1

1

4.1(e) General requirements-QMS (4.2.1)

Monitor and measurement

8.2

1

4.1(f) General requirements-QMS (4.2.1)

Continuous improvement

8.5.1

9

4.2.1(a) General doc. requirements (4.2.2)

Q policy, Q objectives

5.3, 5.4.1, 5.1(c), 5.6.1, 6.2.2(d), 7.1(a)

6

4.2.1(b) General doc. requirements (4.2.2)

Q manual

4.2.2

1

4.2.1(c) General doc. requirements (4.2.2)

Documented procedures

4.2.3, 4.2.4, 8.5.2, 8.5.3, 8.3, 8.2.2

6

4.2.1(d) General doc. requirements (4.2.2)

Other docs.

7.5.1(b)

1

4.2.1(e) General doc. requirements (4.2.2)

Records

4.2.4

4.2.3

2

4.2.2(a) Quality manual (4.2.1)

Scope, exclusion

1.2

4.1(a)

2

4.2.2(b) Quality manual (4.2.1)

Documented procedures

4.2.1(c)

6

4.2.2(c) Quality manual (4.2.1)

Process interact

1.2

4.1(b)

2

4.2.3 Control of documents (4.5)

Records

4.2.4

4.2.1(e)

2

5.0 Management responsibility

5.1 Management commitment (4.1.1)

Continual improvement

8.5.1

9

5.1(a) Management commitment (4.1.1)

Regulatory

7.2.1(c), 7.3.2(b)

2

5.1(b) Management commitment (4.1.1)

Quality policy

4.2.1(a)

6

5.1(c) Management commitment (4.1.1)

Quality objectives

4.2.1(a)

6

5.1(d) Management commitment (4.1.1)

Management reviews

5.6

1

5.1(e) Management commitment (4.1.1)

Resources

6.1, 6.2

2

5.2 Customer focus (4.3.2)

Customer satisfaction

7.2.1, 8.2.1

6.1(b)

4

5.4.1 Quality objectives (4.1.1)

Quality objectives

7.1(a)

4.2.1(a)

5

5.4.2 QMS planning (4.2.3)

Customer requirements

4.1

4.2.1(a)

6

5.6.1 Management review (4.1.3)

Quality policy, quality objectives

4.2.4

5.4.1(a)

6

5.6.2 Management review (4.1.3)

Audits/CAPA/customer satisfaction

5.2, 7.2.3, 8.2.2, 8.5.2, 8.5.3

5

5.6.3 Management review (4.1.3)

Resources

5.1(e)

2

6.0 Resource management

6.1(b) Provision of resources (4.1.2.2)

Customer satisfaction

5.2

4

6.2.1 Human resources (4.1.2.2)

Training/resources

5.1(e), 5.6.3(c), 6.1, 7.4.2, 7.5.2(b)

5

6.2.2(d) Human resources (4.18, 4.1.2.2)

Quality objectives

4.2.1(a)

5

6.2.2(e) Human resources (4.18, 4.1.2.2)

Records

4.2.4

1

7.0 Product realization

7.1 Planning of product realization (4.2.3)

General requirements

4.1

1

7.1(a) Planing of product realization (4.2.3)

Quality objectives

5.4.1

5

7.1(d) Planing of product realization (4.2.3)

Records

4.2.4

1

7.2.2 Review of requirements related to product (4.3)

Records

4.2.4

1

7.2.3 Customer communication (4.3)

Customer complaints

8.5.2(a)

1

7.3.2 Design and development(4.4)

Records/reg.

4.2.4

5.1(a)

2

7.3.4 Design and development(4.4)

Planning records

4.2.4, 7.3.1

2

7.3.5 Design and development(4.4)

Planning records

4.2.4, 7.3.1

2

7.3.6 Design and development (4.4)

Planning records

4.2.4, 7.3.1

2

7.3.7 Design and development (4.4)

Records

4.2.4

1

7.4.1 Purchasing (4.6)

Records

4.2.4

1

7.4.2 Purchasing (4.6)

Training

6.2.1

1

7.5.1(f) Control of production and servicing provision (4.9, 4.15.6, 4.19)

Work instructions

4.2.1(d)

1

7.5.2(d)Val. of processes production and servicing provision (4.9)

Records

4.2.4

1

7.5.3 Identification and traceability (4.8, 4.10.5, 4.12)

Records

4.2.4

1

7.5.4 Customer property (4.7)

Records

4.2.4

1

7.6 Control of monitoring and measuring devices (4.11)

Records/ customer requirements

4.2.4 7.2.1

Guidelines note 1—ISO 10012-1, -2

2

7.6(a) Control of monitoring and measuring devices (4.11)

Records

4.2.4

1

8.0 Measurement, analysis and improvement

8.1(c) M,A,&I—General (4.10.1, 4.20.1, 4.20.2)

Continual improvement

8.5.1

9

8.2.1 Customer satisfaction (new)

Customer satisfaction

5.2

4

8.2.2 Internal audit (4.17)

Records/CAPA

4.2.4, 8.5.2

Guidelines note 2—ISO 10011-1, -2, -3

2

8.2.2(a) Internal audit (4.17)

Production planning

7.1

1

8.2.3 Monitoring and measurement of processes (4.17,4.20)

CAPA

8.5.2, 8.5.3

2

8.2.4 Monitoring and measurement of product (4.10, 4.20)

Production planning Records

4.2.4, 7.1

2

8.3 Control of nonconforming product (4.13)

Records

4.2.4

1

8.4(a) Analysis of data (4.20)

Customer satisfaction

8.2.1

5.2

4

8.4(b) Analysis of data (4.20)

Product requests

7.2.1

1

8.4(c) Analysis of Data (4.20)

Preventive action

8.5.3

1

8.5.1 Continual improvement (4.1.3)

Continual improvement

4.1(f), 5.1, 5.3, 5.6, 5.4.1, 8.1(c), 8.2.2, 8.4, 8.5.2, 8.5.3

10

8.5.2 Corrective action (4.14.1, 4.14.2)

Records

4.2.4

1

8.5.2(a) Corrective action (4.14.1, 4.14.2)

Customer complaints

7.2.3

1

8.5.3 Preventive action (4.14.1, 4.14.3)

Records

4.2.4

1

The table also alerts the reader to specifically referenced ISO 9000 guidelines that are provided as notes within the Standard.

5.7.3 Application

The concomitance table is used when we create the manual or prepare an audit. In these two cases, we wish to know how interactive each clause is as we write text or prepare an audit and make references to other documentation. The number of links becomes a clue as to just how to cross reference our work. As we might anticipate, continual improvement has the most links, followed by several other topics that include processes and objectives.

For example, in carrying out an audit of management responsibility, it is necessary to not only audit all the SHALLS of Section 5.0, but also the requirements in Par. 6.1 and Part 8.5.1.

As demonstrated in the table, implicit requirements are a common thread throughout the Standard. As a result, it is relatively ease for interpretations to vary considerably among practitioners. In fact, each issue of the monthly publication Quality Systems Update (<qsunews@aol.com>) devotes a several-page discussion of interpretations by highly qualified practitioners. The International Automotive Sector Group periodically releases interpretations for the QS-9000:1998 Automotive Standard interpretations that also appear in Quality Systems Update. You will undoubtedly find more concomitance as you begin to work the process of conformance. Suffice it to say that the Standard's web of requirements is most complex and one should not take such implications lightly if the desire is to have a completely responsive QMS.

As a result, to ensure total system concomitance, we maintain that it is necessary to respond to every SHALL in a given Standard's element and to present this information in the manual.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

flylib.com © 2008-2017.
If you may any questions please contact us: flylib@qtcs.net