Please clarify the difference between quality assurance manual and quality assurance plan and if there is any hierarchy or relationship.
Thank you very much for your question. There is a relationship between the two, though they serve slightly different purposes:
A Quality Manual…
…is the collective set of documentation that defines and describes an organization’s Quality Management System. It typically includes:
Quality Policy Statement – The organization’s commitment to quality.
Quality Policies - High level documentation that address “WHAT” the organization is going to do. (Establish, document and maintain a system…commit responsibility from top management…dedicate resources…design and produce products or services…monitor and measure activities…etc.).
Standard Operating Procedures - More specific documentation that details “WHO” will carry out activities, and “WHEN” they will be carried out.
Work Instructions – These are the very specific procedures that describe exactly “HOW” different activities will be carried out. These are often not included in the Quality Manual itself, but are referenced in the Standard Operating Procedures and maintained as a separate but related set of documentation.
All together, this collection of documentation defines and describes the organization’s Quality Management System, from a description of the overall system, through related processes and down into the procedures and work instructions. These documents are not related to a specific product (or category of products) but are more general in the sense that they describe how you run your business/organization. A Quality Manual is required by the ISO 9001:2008 standard (and many others).
A Quality Plan…
…on the other hand, is the collective effort put into identifying all of the activities and requirements that need to be in place in order for the organization to produce the product or service as it is designed. This includes customer requirements, quality criteria and standards, and all of the day-to-day Quality Assurance and Quality Control activities that will need to be in place.
Quality Assurance involves proactive efforts made before production begins, with a focus on improving processes so that fewer defects are produced. This includes process checklists, the development of methodologies and standards, and other similar efforts.
Quality Control refers to the more reactive efforts that take place after a product is built, focused on identifying defective products or services. This includes, for example, the inspection, monitoring and measurement of completed products.
A Quality Plan is specific to a particular product or service, and details how you will meet the requirements of the customer or contract. Some organizations do a great deal of project work, and so in addition to the organization’s general Quality Management System and Quality Manual, they may also produce a Quality Plan for each project. The same could be true for a manufacturing company that produces different parts with unique applications and design/manufacturing requirements.
- Ted Annis, President, The Business Resource Centre