5.13 Manual Configurations


5.13 Manual Configurations

5.13.1 Two Unique Configurations

We will now demonstrate that regardless of which format is chosen for the manual's sections—direct sequence, Shewhart cycle, operational cycle, or use of another standard's sequence—there are effectively only two unique ways to design the manual's configuration:

  1. Model I—stand-alone document that deals only with policy, scope, justified exclusions, the interaction between processes, and references to procedures;

  2. Model II—integrated document that contains both policy, justified exclusions, the interaction between processes, and the procedures.

We maintain that any other form of documentation is a variation of one of these two basic forms. In addition, we will treat the manner in which linkage from the manual to lower-level documentation can be performed effectively.

The configuration decision is paramount in the choice of just where to place the quality policy statements. We have found it to be the primary source of conflict in manual design.

5.13.2 The Stand-Alone Configuration—Model I

In the case of a stand-alone manual—if the writer meticulously follows the criteria stated in the previous sections for the structure of quality policy statements—there will be no policy statements in the lower tier documents, because it will be unnecessary. Thus, we avoid redundancy, which is a night-mare in the maintenance of QMS documentation.

The stand-alone manual clearly references each lower tier document that it directly effects (e.g., the manual's Section 8.5.2: Corrective Action would send the reader to an SOP entitled "Corrective Action Procedure." This requirement for a referenced procedure is based upon both Par. 4.2.1(c) Documentation Requirements—General of the Standard and Par. 4.2.2(b) Quality Manual of the Standard.

5.13.2.1 Section References

This is normally done by inserting a reference document in each section of the Standard. Such an approach can produce a very complex and difficult navigational problem if there are many tier II documents. A typical example of this complex case would be in Section 7.5: Production and Service Provision, which might look like this: "The Excellent Corporation documents related to Production and Service Provision are to be found under the following:

1.

Doc# 2-075-012, Production Control Procedures;

2.

Doc# 2-075-011, Materials Control Procedures;

3.

Doc# 2-075-004, Use of the Traveler Procedure;

12.

Doc# 2-075-008, Release of Capital Equipment."

A way to avoid this difficulty is to create a process-related hub document that acts as a documentation flow center (refer to Table 11.1). When a hub document is used, the manual sends the reader to a handy universal bucket (hub) document (e.g., realization processes), and the hub document sends the reader to all of the documentation shown above.

5.13.2.2 Direct Sequence Stand-Alone Manuals

The exact form of the manual:1994 stand-alone manual has been almost entirely based on the direct ISO 9000 sequence, as described previously (i.e., a one-to-one correspondence to the numbering system of the Standard). This practice, to date, has held true for a manual:2000.

5.13.2.3 Quality Policy Statement Imperative

By definition, as defined in ISO 9000:2000, Par. 3.7.4, quality manual, we see that the manual is to specify the QMS in such as way as to direct and control the organization's quality imperatives. We also learn that the quality policy, as expressed by top management, is the way in which the organization receives the overall intentions and direction in relation to quality.

We conclude, therefore, that once the supplier has entitled a stand-alone document as the "Quality Manual"—regardless of the way a supplier chooses to label the contents of that manual—one thing we believe is clear is that all quality policy statements, to whatever level of detail is required, should be contained in the manual.

5.13.2.4 Primary Source of Inconsistency

The stand-alone manual configuration is the primary source of inconsistency in manual design because of the tendency to place policy statements not only in the manual but in lower tier documents as well.

5.13.2.5 Application to Third-Party Assessments

It is important to keep in mind that third-party assessors tend to go SHALL by SHALL through the manual on each clause, and each SHALL must be addressed. This exercise is prevalent at the document review, and it is far easier to accomplish this task when every SHALL is clearly addressed. If not, the result is a number of nonconformances.

Although many of the quality manual nonconformances at the document review are minors, they still require nonconformance reports (NCRs) and time to respond. The NCR could be a major finding if the process does not clearly exist.

In some cases (e.g., for a rewrite of 8.2: Monitoring and Measurement), the amount of rewrite could be so extensive that it would probably have to be done through the mail. This is certainly not the end of the world, but it could delay the certification by some number of weeks.

5.13.2.6 Corrective Actions for Dislocated Quality Policy Statements

If, as is often the case, the quality policy statements are located in lower tier documents, any one of the following corrective actions have been found to be acceptable:

  • Cut and paste the statements into the quality manual (this minimizes redundancy);

  • Copy the statements into the quality manual (this action does create redundancy but is not a nonconformance unless the lower tier document statements disagree);

  • Include the lower tier document as part of the quality manual (this makes for a very heavy quality manual but is acceptable).

From an operational standpoint, although the placement of quality policy statements into lower tier documents instead of in the quality manual is commonplace, the fact that they are in a lower tier document that is not part of the quality manual is ineffective for the following reasons:

  • Decision makers who require quality policy information would seldom (if ever) have the whole set of lower tier documents at their disposal;

  • Lower tier documents generally contain proprietary information and are restricted in their distribution.

  • The search for quality policy statements during a certification audit can lead to considerable waste of time and effort for all concerned.

I choose the stand-alone format. The desire to provide an adequate, consolidated statement of the organization's quality imperatives in one easily accessible and serviceable document is why essentially all suppliers have chosen the stand-alone form of the quality manual, and this is our recommendation. (Guidance on this subject is found in ISO 10013, "Guidelines for Developing Quality Manuals.")

5.13.3 The Integrated Manual Configuration—Model II

In an integrated manual, the quality policy statements and the lower tier documents—especially tier II—all appear in the same document. This is an approach that was commonly used some 30-plus years ago and can still be found in Mil-Q-9858A and FDA/CGMP-oriented manufacturing operations, as well as in the automotive industry.

In practice, in smaller companies, the manual and the set of SOPs are often distributed together in response to the Standard's Element 4.2.3(d): Control of Documents requirement to ensure that documentation is available where it is to be used. Let us consider the implications of the integrated manual approach [32].

Specifically, let us assume that we have chosen the integrated quality manual configuration. The manual will contain all of the quality policy statements required by the Standard in either of the following forms:

  • Case I—process/SOP documents (tier II) that begin with a policy statement and are immediately followed by the process/procedural information (a joint document);

  • Case II—abbreviated quality policy statements that reference an attachment that contains pertinent tier II as well as the rest of the required quality policy statements.

Figure 5.9 illustrates the form that such manuals could take.

click to expand
Figure 5.9: Schematic representation of possible integrated manuals.

As we noted earlier, such an approach is in full compliance with the Standard [i.e., Clause 4.2.2(b), which requires that the quality manual either includes procedures or refers to them].

5.13.3.1 Implementation

However, the implementation of such a decision is far from trivial, and we want to outline some of the more obvious issues:

  1. When the assessors ask for the manual, they will expect to see the complete manual [i.e., either the full joint policy and tier II documented manual (case I) or all of the front-end text and the tier II appendix (case II). The appendix must include the full set of tier II documents that provide the rest of the required quality policy statements].

  2. In the case of an appendix, they will expect to see the tier II attachment fully noted as part of the manual.

  3. All attachments will need to be under document control; however, the list of tier II documents in the appendix need not show the revision dates because they will not expect you to keep more than one master list of documents. But they will need to know the full contents of any appendixes, either up front in the table of contents or as a part of the attachment.

  4. When they check the distribution of controlled manuals, they will expect to see a complete document in the auditee's area. The "complete document" is the same as defined earlier (i.e., either the full jointly documented manual or the policy/appendix tier II manual).

  5. When a specific quality policy statement is searched for—in response to a SHALL in the Standard—they can accept its presence anywhere in the integrated manual (i.e., front-end text or attachments).

  6. They will expect to see a defining statement in Section 4: Quality Management System of the manual to the effect that the manual does consist of a set of either jointly documented tier I/tier II text or of abbreviated quality policy statements and associated tier II documents contained in an appendix.

Figure 5.10 offers a qualitative comparison of the stand-alone versus the integrated manual approach. The comparative analysis is indicated in an associated Table 5.17.

Table 5.17: Comparative Analysis of Configurations

Attributes

Stand-Alone Manual

Integrated Manual

Size scales with original size and complexity

Typically 30 to 75 pages without appendixes

Only quality policy statements

Hub approach—200-plus pages without appendixes and forms.

Can be considerably larger without a hub approach or for multisite manuals; only tier I/II documents for a single division or site

Redundancy

Usually has some with tier II and even tier III documents

Low probability

Linkage

By reference—somewhat difficult to learn

Direct linkage

As a teaching tool

Powerful with a big picture viewpoint

Somewhat limited because of narrower viewpoint

As a marketing tool

Outstanding—can clearly define organization's personality and image

Not really viable for marketing purposes—an issue of proprietary information and big-picture focus

Ease of auditing

Readily available information

Quality policy statements readily found.

Readily available information

Quality policy statements could be obscured

Ease of distribution

Can distribute manuals and tier II documents to custom fit the area

Each tier II area requires the entire manual to find its pertinent documentation

Overall

Most common in use

Not commonly found to date in ISO 9000 certifications

click to expand
Figure 5.10: Graphic comparative analysis of configurations.

5.13.3.2 Discussion

As a result, the true difficulties with the integrated manual approach are with regard to the following:

  • Large size;

  • Diluted marketing orientation;

  • Overkill in distribution.

It could get even more cumbersome in a multidivisional operation where it might happen that one manual was to be used in all divisions so that not only the corporate-level procedures but also the divisional-level procedures would be combined in one binder.

We have observed organizations' attempts to use an integrated manual approach by modifying their present Mil-Q-9858A or FDA/CGMP 820 documentations, but have eventually changed to the stand-alone model for ease of use and distribution. However, this approach has been used successfully in those cases where the supplier had little concern about the proprietary nature of the tier II documents and thus was not concerned about its distribution as part of a manual. We strongly recommend the use of a stand-alone quality manual for ease of use and flexibility.

[32]We do not wish to imply a dislike of the integrated manual. This is not the case because in my own practice I have designed integrated manual systems when it was required. However, as noted, this form of manual requires considerable thought with regard to ease of use, distribution, and maintenance.




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

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