About Quality Plan

For the organizations which are implementing their ISO 9000 series Quality System, they may always feel uncertain about what should be included in the Quality Plan. Actually, they do not know what is the meaning of the Quality Plan that ISO 9000 talking. In the real life, I have seen some organizations included almost all materials such as drawings, flowcharts, memo, specifications, bill of materials, shipping instructions, engineering instructions, parts list and some photos of the products in the Quality Plans. On the other hand, some organizations can still got their ISO 9000 series certifcates even without a single Quality Plan. So that, what ISO 9000 series standards actually want ?

Ref. to ISO 9004-1: 1994, clause 5.3.3,

"Quality plans should define:

  1. the quality objectives to be attained (e.g. characteristics or specifications, uniformity, effectiveness, aesthetics, cycle time, cost, natural resources, utilization, yield and dependability);
  2. the steps in the processes that constitute the operating practice of the organization (a flowchart or similiar diagram can be used to demonstrate the elements of the process);
  3. the specific allocation of responsibilities, authority and resources during the different phases of the project;
  4. the specific documented procedures and instructions to be applied;
  5. suitable testing, inspection, examination and audit programme at appropriate stages (e.g. design and development);
  6. a documented procedure for changes and modifications in a quality plan as projects proceed;
  7. a method for measuring the achievement of the quality objectives;
  8. other actions necessary to meet the objectives."

With the points (a) and (g), it is clear that a Quality Assurance Specification which includes all the acceptance criteria during different production stages is a must. Also, the final drawings of the product and the critical parts are necessary (the whole set of drawings can be kept in the design file so that it is not necessary for the Quality Plan). With point (b), it is definitely pointing to a production process flowchart. From this flowchart, we can provide similiar flowcharts which show the introduction of manpower, machines/equipment and materials by similiar means so that point (c) can be done. With point (e), a Quality Control Specification which clearly defines the inspections required in different stages of production is a must. It is clear that the specification should clearly defines the sampling size and acceptance criteria of the inspections. Details of the inspections can be shown in the form of Working Instructions or Technical Instructions, so that it is not necessary to be included in the Quality Plan. Finally, a standard Quality Procedure namely "How to Modify Quality Plan" may be the best way for point (f). Therefore, it is not necessary to write a page in each Quality Plan to define the procedure of Quality Plan modifications.

Therefore, we can have a extremely short list for the Quality Plan:

  1. Quality Assurance Specification
  2. Final Product Drawing and Drawings for Critical Parts
  3. Processes Flowchart, Manpower Flowchart, Material Flowchart and Equipment Flowchart
  4. Quality Control Specification (Only List of Inspections, no Details required)

By William Wong, 18-Nov-95
Back to Quality Plaza