5.3 Strategic Framework for the Manual


5.3 Strategic Framework for the Manual

5.3.1 Unified Approach—Integration of Enterprise Strategy with Quality Management

We support the Standard's imperative that the manual should integrate enterprise strategy with quality management. This unification of enterprise strategy with quality management is accomplished by top management when it establishes quality policies and quality objectives that include the total organization's functions, (e.g., executive, marketing and sales, research and development, engineering, manufacturing, after-sales service, and the complementary functions of finance, quality assurance, and management information systems). This holistic approach (i.e., where the sum is greater than its parts) is inherent in the ISO 9001:2000 requirements.

This initiative can be further enhanced to include other related Standards that form the total organizational management system. For example, The American Society for Quality (ASQ) and the American National Standards Institute (ANSI) have declared that the quality management theme for the twenty-first century is to be Management Systems Integration—the integration of a QMS with both an environmental management system (EMS) and an occupational safety and health management system (OSHMS) [10].

Because the manual, if properly structured, can be readily modified to include the requirements of other associated standards (e.g., the manual becomes the enterprise/quality integrator of this total organizational strategy because it serves as the fabric upon which is imprinted the vision of the organization). The prescriptive quality policy statements that are the central tenets of the manual drive the operational processes, which in turn form the basis for TQM. This process forces every author to think deeply about the organization's mission and purpose.

5.3.2 Unified Business and Quality Policy

For example, a way in which business strategy can be integrated within the Standard's quality policy requirements is demonstrated in Table 5.2. In this table we have given examples of the manual's opening responses to the Standard's Clause 4.1, entitled "Quality Management System." The several suggested paragraphs are presented as quality policy statements that incorporate a fully integrated business/quality management system approach. The examples are not meant to be a complete response to Element 4.1 but they do form a context that considers the interaction between the Excellent Corporation and its registrar.

Table 5.2: Unified Business and Quality Policy Format—Typical Quality Policy Statements Against the Requirements of the Standard That Also Considers the Registrar's Requirements

Manual's Paragraph Labels and Content

Typical Paragraph Content in the Form of Quality Policy Statements

Business and certification scope (requires registrar's review and acceptance) (usually placed prior to Section 4.0 in the manual)

Describes history, products, and locations of the business covered by the certification assessment.

Example: "The Excellent Corp. maintains an online documented and continually improving QMS that facilitates the sales and marketing, design, manufacture, and servicing of SMT assemblies worldwide. The corporate office is located in Boston, MA, and is supported by sales and manufacturing facilities in the United States, Europe, and the Far East."

Vision statement (usually placed prior to Section 4.0 in the manual)

Defines very-long-range business objective.

Example: "The Excellent Corp intends to maintain a dominant and globally recognized market position in the SMT industry."

Mission statement; can be corporate level and/or divisional/department level (usually placed prior to Section 4.0 in the manual)

Defines key objectives required during the next several years to achieve the vision.

Example: "To achieve dominance, the Excellent Corp. will continually improve the effectiveness of its processes based on the eight management principles inherent in the ISO 9001:2000 requirements."

Quality-policy statement (refer to Par. 5.3 of the manual for detail)

A relatively short thematic statement that embodies the basic quality principles that every employee can remember. A more complete quality policy statement is also prepared, signed by the top manager, and posted throughout the organization.

Example: "Quality within the Excellent Corp. means never being satisfied with anything less than a delighted customer."

Quality objectives/metrics (refer to Par. 5.4.1 of the manual for detail)

A list of key measurements that are used to define organizational success.

Example: "Continual improvement is measured through the trend analysis of (a) customer satisfaction and dissatisfaction (customer returns and complaints, reorders, overall market share); (b) internal improvement metrics (yields, scrap); (c) corrective and preventive actions; and (d) return on net worth."

Process-based QMS

Discusses the method used to describe the organization's processes and their interrelationships.

Example: "Business and quality are synonymous at the Excellent Corp. and are inexorably bound by means of critical process maps of the organization's core competencies (i.e., marketing and sales, engineering, manufacturing, service, and finance). An annual budget based on business/quality objectives is used as the means to supply the necessary resources to effectively control these processes."

Customer needs and expectations (refer to Par. 8.4 of the manual for detail)

Discusses how the organization obtains knowledge of customer requirements, satisfaction, and dissatisfaction.

Example: "The Excellent Corp. determines customer needs and expectations by means of its core competency in marketing and sales, which is defined as a critical process map, and interfaces rigorously with the engineering core competency, which is also define by a critical process map. Formal surveys of customer satisfaction and dissatisfaction levels are routinely collected quarterly."

Propagation of the quality policy (refer to Par. 5.1 of the manual for detail)

Discusses how the total quality policy is communicated to all employees and who is responsible for its implementation and maintenance.

Example: "The President of the Excellent Corp. holds an integrated business/quality quarterly meeting with the entire staff to review the organization's quality progress and status against its business/quality objectives."

The blending of quantitative marketing objectives and financial metrics into the business/quality objectives creates a manual that unifies business and quality strategies into one. In this manner the manual becomes the organization's repository of operational knowledge that can form the basis of a learning organization.

Quality management systems based on the 1994 version of the International Standard tended to ignore such key enterprise protocols as the manner in which price lists are created and approved, and the manner in that all marketing channels are a source of customer complaint inputs [11].

The powerful roles played by marketing and finance are no longer conjectural in the Standard but are to be expressed through the requirement to identify QMS processes and to define interprocess sequence and interaction. For example, although cost of quality has always required an explicit contribution from finance, the finance departments were usually considered outside of the "quality" requirements and finance personnel were treated as second-class ISO citizens. However, a few moments of introspection always produced the manner in which finance played a key role in the ISO process (e.g., cost-of-nonconformance estimates, engineering cost workups, pay-back calculations for new capital equipment, and scrap analysis). This obviously exclusive rationale should no longer be tolerated based on the Standard's all-inclusive requirements [12]. Indeed, the finance department has been rediscovered in ISO 9001:2000!

Furthermore, the manual, when installed on an intranet, can also be used as the basis for the organization's information technology (IT) imperative that supports process development—the cornerstone of enterprise reinvention that can result in customer delight. As such, the manual can provide the channel that ties together the global operations of an organization.

The use of electronic media and intranets has produced an impressive array of documented systems that support outstanding databases used to analyze QMS effectiveness. There is now sophisticated software to cover security, enterprise resource planning (ERP), payment systems, fulfillment, customer relationship management (CRM), direct procurement, indirect procurement, supply chain management (SCM), Web-based computer-aided design, web-based product development, partner relationship management, and the blossoming of wireless network technology [13].

5.3.3 Proprietary Information

Top executives are often concerned about the visibility of business metrics such as profit and loss statements and balance sheets. Such proprietary information need not be detailed within the manual. For example, marketing strategies, cash flow, and profit and loss information are readily placed in a separate business plan that is then referenced in the manual. Our concern is with process so what is most important is that there exists an effective protocol that stipulates how marketing strategies are to be developed, how cash flow is to be measured and controlled, and how profit and loss information is to be used to improve the operation's corrective and preventive action programs.

Any situation in which proprietary information could become an issue should be discussed ahead of time with the registrar (i.e., the organization you have hired to certify you). Usually, third-party lead assessors are very cautious about reviewing either proprietary business information or personal employee data. It is not uncommon for third-party assessors to be refused entrance to a specific operational area but to treat the area as a black box through the examination of what product or service goes in, what transformation occurs to those inputs, and what product or service comes out of the black box. This is readily achieved through audits of the pertinent documentation, records established in the restricted area, employee qualifications, and interviews with the local area managers held outside of the restricted area.

In a proprietary situation, there is always a way to review documents, test out implementation, and determine system effectiveness. For example, restriction from an area can occur in audits of laboratory-bred animals. I have held a number of audits speaking through a glass window to operators who held up records for me to look at in those areas that required more than a "bunny suit" due to contamination issues.

Thus, in the thoroughness of my work, I often come across specific information that the client does not wish to disclose. This is never a problem because my primary purpose is to analyze processes, and so as long as the process is properly documented in some way, is implemented according to some plan, and there is some way to determine effectiveness, it is unnecessary to report the proprietary details—only the verification and validation of the process.

As a result, a manual that stresses this unified perspective indicates that the supplier has considered ISO 9000 in terms of their overall strategic enterprise directions and has carefully determined how the QMS serves to support these directives.

In fact, we have observed a number of organizations that have chosen this unified approach as the starting point for their manual. In our opinion, it has resulted in a very effective document in terms of its value to decision-making readers. Such suppliers have received very high marks on their manual from both customers and registrars. Years later, even after several recertifications, the basic unified structure has so reinforced the QMS that it readily withstands major organizational changes including executive reorganizations, acquisitions, and the fluidity of the global markets.

5.3.4 The Design of Quality Policy Statements

The creation of effective quality policy statements required a decision with regard to the degree of responsiveness required in response to a given ISO 9001:2000 requirement (SHALL). It is necessary to agree on what is appropriate for our purposes.

The highest level of response is the manual, often termed tier I or level I, in that our response to the specific SHALLS is to be given in terms of quality policy statements (i.e., written declarative statements that explain how the organization conforms to the Standard's requirements) [14].

Ideally, a quality policy statement is in the form of prescriptive language that directly addresses the descriptive language of the Standard. For example, if the requirement mandates that a company's top management establish quality objectives that are measurable, the prescriptive response would be of the following type:

Wolf TL, Inc., measures its total business/quality performance by means of seven key metrics:

  1. New product introduction time;

  2. Bid wins versus loss ratio;

  3. Surveyed customer satisfaction versus dissatisfaction;

  4. First pass yield;

  5. On-time versus late deliveries;

  6. Rate of return of product;

  7. Economic value added.

Such prescriptive quality policy statements drive the structure of the entire documentation system, the implementation of that system, and the manner in which the effectiveness of that system is demonstrated. Effectiveness is often seen as a reduction of variance throughout the enterprise's operating systems, which is reflected in increased productivity and profitability [15].

5.3.5 Manual's Value Within the QMS

We maintain the following:

  • A QMS that is based upon a manual that is fully responsive to the Standard results in a strategic declaration of the organization's quality and technical competence as stated in the manual in the form of prescriptive quality policy statements. To be fully responsive means that the QMS has integrated business strategy with quality management in full compliance with the Standard's SHALLS;

  • In opposition to a fully responsive QMS, we maintain that a paraphrased set of quality policy statements results in a less than effective QMS—by paraphrased, we mean a playback of the Standard's descriptive requirements in the manual—as opposed to prescriptive statements that indicate the methods used to actually conform to the Standard.

  • Paraphrased manuals lack so much useful information about the organization that they are often simply ignored as a key document to review during internal quality audits.

5.3.6 Prescriptive Versus Paraphrased Methods

The QMS process and our thesis is illustrated in Figure 5.2. The diagram illustrates how the requirements of any Standard are heavily influenced by the organization's interpretive scheme to produce either a fully responsive QMS based upon prescriptive quality policy statements (QPS) in the manual or one based upon ineffectual, paraphrased statements in the manual.

click to expand
Figure 5.2: The QMS manual thesis.

The use of prescriptive quality policy statements explicitly drives the lower level process, procedure, and formatted QMS documents and produces a balanced set of hierarchal documents. The QMS is then dynamically balanced in terms of its documentation system, the implementation of those documents, and the degree to which one can demonstrate the effectiveness of the system to achieve its quality objectives.

By contrast, the use of descriptive, paraphrased statements produces a system that is narrow at the top and heavy at the bottom from a hierarchal standpoint. There is no assurance in this case that the lower level documents accurately reflect an organization's strategic policies that are vaguely described in the paraphrased manual.

[10]See, for example, Harwood, David, "Integrating Quality, Health, Safety, and Environmental (QHS&E) Management Systems with Central Document Control," Proc. Eighth Annual International Conference on ISO 9000, February 7–8, 2000, Orlando, Florida.

[11]Although there is a plethora of books on these subjects, Chapter 25 of Kotler, Philip, Marketing Management, Sixth Edition, Englewood Cliffs, NJ: Prentice Hall, 1988, provides a excellent and surprisingly up-to-date summary of the role of finance and marketing in the corrective and preventive action process.

[12]See, for example, Campanella, Jack (ed.), Principles of Quality Costs, Second Edition, Milwaukee, WI: ASQ Quality Press, 1990.

[13]See for example: Crist, Roger, "E-Documenting for Better Control," Quality Digest, March 2001, p. 41 (http://www.qualitydigest.com). Also, monthly publication Managing Automation, Thomas Publishing Co., New York (http://www.managingautomation.com), is a cornucopia of information related to the diverse methods in use today to automate enterprises (e.g., Neil, Stephanie, "The Untethered Terrain of Wireless," Managing Automation, April 2001, p. 26, and Rice, Valerie, "Success with Web Customer Service Depends on More than Technology," p. 34. The June 2001 issue of Managing Automation lists 96 companies that sell manufacturing software.

[14]There is a difference of opinion on whether the quality manual requires quality policy statements for each SHALL of the Standard. This remains a fundamental issue in manual structure. Our interpretation is based upon Annex C of the ISO 10013:1995 Guidelines for Developing Quality Manuals. In this annex, the example given is the set of quality policy statements that form a response to Element 4.17: Internal Quality Audits of the 1994 Standard. The ISO "Guidance on the Terminology Used in ISO 9001:2000 and ISO 9004:2000" defines "Shall (Shall not): Used to indicate a requirement strictly to be followed in order to conform to the standard and from that no deviation is permitted. Do not use 'may' or 'may not' as alternatives." (http://www.iso.ch).

[15]Edward P. Link publishes a pocket-sized booklet that stresses the value of reduced variation as it relates to ISO 9001:2000 [i.e., An Audit of the System, Not of the People, Quality Pursuit, Inc., Rochester, NY, tel: (716) 586–2680].




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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