Chapter 5: Quality Manual Design


5.1 A Quality Manual Is a Mandatory Document

A quality manual is a document that specifies an organization's QMS [1]. The Standard further specifies that the quality manual is to include the following [2]:

  1. The scope of the QMS and details and justification for exclusions;

  2. The documented procedures or reference to them;

  3. A description of the interaction between the processes.

And that's it—a broad umbrella requirement and only three specific conditions. Exclusions refers to a statement of nonapplicability for a particular clause. The most common exclusion is Clause 7.3 Design and Development (e.g., a machine shop that manufactures parts based on the customer's design would exclude Section 7.3).

The manual stands as a colossus above the ISO 9000 documentation hierarchy and sources the flow of the QMS. Accordingly, this chapter describes the design of a fully compliant ISO 9001:2000 Manual. However, although it is always best to keep the sections of documentation as small as possible, because of the approximately 40 specific areas of interrogation (i.e., distinct portions in the Standard with specific requirements), this is not possible. For example, Section 7 of the Standard has approximately 12 such distinct categories (i.e., 7.1, 7.2.1, 7.2.2, 7.2.3, 7.3, 7.4, 7.5.1, 7.5.2, 7.5.3, 7.5.4, 7.5.5, and 7.6).

As a result, we require an increased level of complexity beyond what we would normally consider. In fact, this book's longest text concerns the design of the manual. Such complexity requires increased employee training in documentation structure and usage. We will assume that the organization is committed to this relatively high level of employee training and has either already mastered or plans to master this art.

Unfortunately, the manual's dominant position in the QMS structure has not been supplemented by explanations that permit the rapid development of effective manuals. It is important that we first deal with the quality manual controversy as a way to understand how to resolve the issue.

5.1.1 The Manual Should Be User Friendly

As a result, the manual should tell the reader at least the following structural information [3]:

  • The number of tiers chosen, their contents, and the method of labeling (see Figure 4.1);

  • The method of document-to-document reference, or linkage (e.g., by either reference numbers in the text or a documentation tree);

  • Whether the system is hard copy, on electronic media, or a mixture;

  • The type of documents to be found (e.g., found either in manuals, in online documentation, by individual copies distributed among employees and/or locations, or on wall reference charts in which the work instruction is posted on or near the work station;

  • How quality management documents (e.g., the manual) are differentiated from engineering documents (e.g., drawings and schematics);

  • The identification of processes and the way that they interact, complemented by a description of their interaction.

Furthermore, we are required to specify a QMS, but the word specify is not defined. We are required to include the scope of the QMS, but the word scope is defined only in a guideline as "the range or extent of action, main purpose, intention"—that leaves much to the imagination [4]. Hence the need for guidance in terms of hierarchal structure and the need for concepts such as prescriptive quality policy statements. In this regard, we recommend that the quality manual should also include the following:

  1. The documented quality policy and its mandatory requirements (refer to Par. 5.3 of the Standard);

  2. The quality objectives and its mandatory requirements (refer to Par. 5.4.1 of the Standard);

  3. The mandatory identification of the core competencies (processes) and how they are applied (refer to Par. 4.1a of the Standard);

  4. The mandatory description of the interaction between the core competencies (processes) (refer to Par. 4.2.2 of the Standard).

5.1.2 A Quality Policy Statement Is a Mandatory Document

We recommend that the quality policy statement be placed within the quality manual. This approach considers the need for ease of distribution and overall visibility. However, the quality policy could just as readily be a separate document. In fact, many organizations place the quality policy statement within the quality manual and then extract it for purposes of display and ready availability.

Either way, the document is to be controlled, usually by signature and date of the top manager, but it could also be signed off by the entire executive team and/or the entire set of employees. The Quality Policy Statement must contain all of the Standard's requirements in Par. 5.3. See the boxed text below for an example of such a statement entitled, "Excellent's Quality Policy Statement."

5.1.3 Statements of Quality Objectives Are Mandatory Documents

We also recommend that the quality objectives, along with their metrics, be placed within the quality manual for the same ease of distribution and overall visibility. By metric, we mean the specific method of measurement (e.g., the ratio of awarded contracts to contracts awarded to competitors, first pass yields in test, or the percentage of shipments made to schedule divided by total shipments). We do not mean by this that the actual data should be placed in the manual, only the metric. For proprietary purposes, the reader should be directed to a separate document in which actual data exists, if and only if they are required to view such data. Targets and goals are included in the data.

Table 5.1 illustrates the kinds of metrics that can be generated to support various quality objectives. An example of a possible quality objective related to that table is discussed in Section 5.1.4.

Table 5.1: An Example of Metrics for Hickory Electromechanical Engineering

Metric

Objective

Metrics and Goals

Responsibility

Databases

1

Maximize contracts awarded (by product)

Contracts awarded to us divided by contacts awarded to competitors (by product); goal is to achieve 100% of awards

Program manager

Data table ..\Reports\COc

2

Minimize returned goods (RGAs)

Products returned over products shipped; goal is to be at 1% or less of shipments

Sales support

Data table ..\Reports\ RmaMetRpt.xls

3

Minimize customer complaints

All complaints analyzed; goal is to maximize positives and minimize complaints and the response time for resolution

All who have customer contacts; business management tallies

Data table ..\Reports\Cus

4

Minimize customer correction actions (CARs)

Corrective action metric; goal is to reduce over time the number of CARs received and to close CARs by due date

ISO management representative

..\NCR's\CAR]s

5

Minimize vendor nonconformance reports

Nonconformance metric; goal is to maintain resolution with vendor at 100% to avoid escalation to a CAR

Purchasing

..\NCR's\NCMs

6

Minimize audit correction actions (ACARs)

Audit corrective action metric; goal is to reduce over time the number of ACARs generated and to close ACAR's by due date

Quality assurance

..\Audits\ACAIs

7

Maximize control of monthly financials

President's report; goal is to achieve budget levels or greater

Finance

..\Reports\XBt.doc

8

Maximize actual sales

Meet or exceed projected sales; goal is to achieve budget levels or greater

Sales manager

..\Reports\ BudvActvF.xls

9

Project budget

Actual project cost; goal is to achieve project budget levels or better

Engineering

Data ..\Reports\XB.doc

10

Minimize actual delivery times/dates

Contract delivery time/dates; goal is zero days or fewer.

Operations

Data ..\Reports\XB.doc

11

Minimize factory acceptance test (FAT) deficiencies

Maximize yields; goal is 0% of FAT deficiencies

Production supervisor

Data table ..\Reports\FAc

5.1.4 Example

Here, the metric will be the percentage of returned product (in warranty). This is the calculation based on the total number of units shipped that remain in a 12-month warranty. The associated quality objective for manufacturing in flow-down is "The manufacturing department is committed to minimizing the number of returned parallel processor boards by means of a vigorous joint program with purchasing to improve overall first pass yield." The metric, percentage of returned product (in warranty) out of the total population of warranty boards, will be used to define the overall quality of the manufacturing/purchasing cross-functional team.

start sidebar
Excellent's Quality Policy Statement The Business of Quality

The Excellent Corporation is committed, at all levels of the company, to total customer satisfaction. To meet this commitment, we provide products and services that fulfill customer expectations, and provide quality at levels greater than that available from any of our competitors.

Our quality management system is based on the International Standard ISO 9001:2000, and we are fully committed to continually improve the effectiveness of our system by means of constant top management review and oversight. This level of attention is complemented by formal management reviews, internal audits, extensive training, and an aggressive corrective and preventive action program that includes crossfunctional teams for root-cause analysis and problem resolution.

To ensure the integrity of our system, quantitative quality objectives based on operational metrics are established, monitored, measured, and reviewed by managers who are held accountable for their results. In addition, all of our employees are thoroughly trained in quality management methods and are supplied with the resources required to ensure that such methods are effective.

At Excellent, business objectives and quality objectives are synonymous.

Signed: John J. Dewolf

Dated: January 1, 2002

President & CEO

The Excellent Corporation

end sidebar

In addition, manufacturing will also use first pass yield as the internal metric and purchasing will use the percentage of acceptance of supplier parts at incoming inspection to monitor supplier performance as its metric. First pass yield is based on the multiplicative yields through incoming inspection yield multiplied by subassembly functional test yield, multiplied by systems validation testing yield (customer supplied test fixture).

The goals for the minimization of returned product are as follows:

  • Percentage of returned product (in warranty) is less than 1%/month;

  • First pass yield is greater than 85%;

  • Percentage of acceptance of supplier parts is greater than 97%.

The goals/targets are best kept in a separate document that is referenced in the quality manual. The reason for this is that the goals could change a number of times during the year as field data is obtained. Such data could cause revisions to the controlled quality manual. In addition, you would want to include the analytical details for the metric calculations in a separate document (e.g., a document entitled "Statistical Analysis Procedures").

5.1.5 Performance Rate

By the use of quality objectives and clearly defined metrics to measure each objective, a key tactic of our integrated QMS is to set the organization's performance improvement rate such that it achieves the organization's business/quality objectives and is attainable from a marketing sense.

We wish to drive the organization's performance at some continuous rate of improvement by means of a clearly defined QMS that is subject to our market imperatives.

[1]Par. 3.7.4 of ISO 9000:2000.

[2]Par. 4.2.2 of ISO 9001:2000.

[3]ISO 9001:2000, Clause 4.2.2.

[4]"ISO Guidance on the Terminology Used in ISO 9001:2000 and ISO 9004:2000," Quality Systems Update, Vol. 11, No. 2, February 2001.




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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