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We have now treated each element of QMS design in some detail and are in a position to summarize the set of design rules—that if applied by authors to the QMS creative process—should resolve all of the issues under consideration (see Table 21.1). The table is arranged in terms of the applied design rule and resultant benefits of the approach.
QMS Design Rules | Benefits of Approach |
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Integrate business strategy with quality management—by means of a total business and quality policy format | Forms the basis of a well-informed organization Supports the organization's information technology imperatives Caters to decision making |
Cleary define all of the organization's core competencies in terms of processes (e.g., marketing and sales, engineering, manufacturing, quality assurance, finance, and customer service) | Will be the framework for the process-oriented QMS design |
Comply exactly with the Standard's requirements Respond positively with a quality policy statement to each SHALL, and adhere to the spirit of the ISO 9001:2000 requirements and guidelines | Ensures compliance with the Standard Enhances the inherent continuous/continual improvement cycle Enhances the possibility of payback |
Utilize stewardship management with cross-functional teams Use experts to write sections | Ensures that top management is committed to the complete documentation, implementation, and demonstration of effectiveness of the program Partially satisfies the affective part of QMS design |
Analyze all processes of the organization prior to the specific design decision Use flow charting methods if possible—otherwise tables and charts | Greatly enhances the development of the quality manual and provide an outstanding base for the hub documents |
Formally declare the specific sequence pattern for the QMS layout (e.g., direct sequence with ISO 9001:2000 elements) and intensively train team members in the approach Select from four possible sequences: direct ISO 9001:2000, Shewhart cycle, operational cycle, and another standard's | Team members will work towards clear linkage to lower level documents Team members will concentrate on operational flow and the continuous/continual improvement cycle |
Formally declare the specific manual configuration (e.g., stand-alone), and intensively train team members in the approach Select from either stand-alone or integrated configurations Be consistent with the placement of quality policy statements |
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Evolve online in the shortest possible time Put level I and II documents online as early as possible Appeal directly to the customer/client's perspective | Leads to significant gains in document control and revision control Lowers distribution and maintenance costs Ensures clarity for all readers Caters to the new customer |
Clearly place all quality policy statements in the quality manual Avoid redundant statements in lower level documents State the quality policy statements once | Creates a fully compliant manual that is clear and precise with regard to the organization's rules, methods, and business strategies |
Include sufficient detail in the quality policy statements Allow the reader to understand how the organization actually works | Provides all readers, especially decision makers, with worthwhile pertinent organizational information Provides a highly effective document for the new customer |
Provide user-friendly navigation tools A four-tier structure Hub documents | Significantly increases the probability of effective implementation by all employees Tends to minimize the number of documents Clarifies linkage |
Avoid paraphrasing | Removes the trivialization of the Standard that is anathema to the quest for continuous/continual improvement where completeness and clarity are mandatory |
Use effective styles such as the following:
| Enhances information flow Increases rate of understanding Increases training retention time Increases rate to find documents |
Use the same design rules for sector-specific requirements | The exact same benefits apply |
Use as many words and charts as is needed to produce the organizational image that is desired | A little long May be too strong— But it ain't wrong Terse is worst! |
Utility—documents should be as follows:
| Enhanced communication A common training vocabulary Propagates the quality policy directive to all employees |
Online considerations:
| Employees tend to get confused immediately when asked to find a specific file unless they can quickly enter a master list of documents Lowers user anxiety through familiarity and is a quick entrance to a master documentation list A very easy and effective technique for QMS documentation navigation Removes user anxiety—a simple cheat sheet Especially important when flow charts are used Topics such as electronic signature control are to be included |
Summary of Global Mandatory Requirements As a memory jogger and very handy check-off list, the following global documentation has been shown to be mandatory (although there are requirements that are partially discretionary):
A QMS;
A quality manual (tier I);
Documented quality policy (tier I);
Documented quality objectives (tier I);
Identification of processes (tier I);
Sequence and interaction of the processes (tier I);
Management reviews (tier I);
Process plans (tier II);
Monitoring, measuring, analysis, and improvement plans (tier II);
Six documented procedures (tier II);
Work instructions as applicable (tier III);
Other documents needed to ensure the effective planning, operation, and control of its processes (all tiers);
Records as required (exist at all tier levels)—to indicate objective evidence of effective operation;
Documents that describe product characteristics (tier III);
Method of linkage between tiers;
Declaration of the ISO management representative;
Description of the organization to be certified;
Specific description of responsibility and authority of at least the top management;
Inter and intra organizational interfaces;
Demonstration of the effective implementation of the system;
The use of sensible levels of documentation;
The effective management of customer complaints;
Declaration of factored items (if applicable);
Master list of current Standards and codes.
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