Need a Quality Plan?
For the past several months we’ve been reviewing ISO 9001 requirements for planning. If you read last month’s column closely ( “Planning for Product Realization,” November, 2007 ), you may have noted an absence of discussion about quality plans. Many ISO 9001 users may never encounter the quality-plan concept. Quality plans provide a means of relating specific requirements of the process, product, project, or contract to the organization’s quality management system (QMS). Although some plans focus almost entirely on QMS aspects related to product realization, in some cases they’re used to relate all of an organization’s QMS processes, activities, and resources to customers’ requirements. Most plans fall somewhere in between, covering topics such as customer communication during a project, monitoring and measurement, analysis and data submission to the customer, competence of personnel, as well as aspects of product realization.
Subclause 3.7.5 of ANSI/ISO/ASQ Q9000-2005 “Quality management systems--Fundamentals and vocabulary,” defines a quality plan as a “document specifying which procedures and associated resources shall be applied by whom and when to a specific project (3.4.3), product (3.4.2), process (3.4.1) or contract.” So, if you have only one type of service, one product or product line, or even several products and services but with similar customer requirements, you might not be familiar with the concept. On the other hand, quality plans are common in some industries and become a real necessity in cases where a single organization has widely varying product lines and customer requirements.
Sometimes the motivation for developing quality plans is internal. The organization simply wants to clarify for employees how the QMS is structured for its various products. Or perhaps a better internal reason might be to fully align the QMS product realization processes with the organization’s quality goals for its most important product line. A quality plan can also serve as a template for auditing the most important issues related to product realization for critical products or services.
Often, however, an organization’s first introduction to a quality plan concept comes as a requirement from a customer who may require an organization to include a quality plan along with a bid and a proposal on a potential contract.
If you suddenly need to work out a quality plan for a project, product, process, or contract, good guidance is available. Just get a copy of ANSI/ISO/ASQ Q10005-2005, “Quality management systems--guidelines for quality plans” from the American Society for Quality. The document describes why quality plans are useful and gives how-to guidance on their development.
The quality plan can be thought of as documenting how the organization will meet objectives for a specific process, product, project, or contract. ANSI/ISO/ASQ Q10005-2005 calls this the “special case” for which a plan is generated.
A quality plan normally consists of descriptions of how required activities are to be carried out. The descriptions are based on the appropriate procedures or documents that give the details. Thus, the quality plan can be thought of as a cross index of the requirements for the “special case” with the organization’s documentation that ensures that those requirements will be met during product realization.
ANSI/ISO/ASQ Q10005-2005 is similar to many standards: It offers a lot of guidance, and most of it might not apply to your case. Fortunately, among the guideline’s best features are its four suggested formats for quality plans. The user can, of course, choose any format that will meet requirements, but the four offered cover most situations. One is a textual format similar to a procedure. The other three are more innovative and useful. The table format lists each key requirement in a column or columns, and the adjacent columns give associated documents that meet each requirement. The flowchart model is formatted as a relationship diagram of the processes for the “special case,” along with annotations referring to the documentation relevant to each activity. The form model combines the flowchart and table, using a vertical flowchart of the process along one axis of the table and giving the key requirements and associated documentation in other columns. I’ve always preferred the flowchart version, but each has its merits. The point is that ANSI/ISO/ASQ Q10005-2005 makes it fairly easy to decide which is best for your case.
Why would a customer require a quality plan as part of a request for proposal? It relates to competence, communications, and confidence. The customer wants to begin at the earliest stages to gain confidence in its supplier’s competence to do the work. To do this, communication is required. The quality plan can be a key element in that conversation.
John E. (Jack) West is a consultant, business advisor, and author with more than 30 years of experience in a wide variety of industries. From 1997 through 2005 he was chair of the U.S. TAG to ISO/TC 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 series of quality management standards. He remains active in TC 176 and is chair of the ASQ Standards Group.
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