Documentation of Quality Management System

A quality system is the method used to ensure that the quality level of a product or service is maintained. The system documentation can be viewed as as hierarchy containing four tiers, as shown in the following illustrations:

All documentation moves from one level to the next in a descending order. If the system is properly structured, changes at one level will seldom affect the level above it, but may affect those below.

Policy

The first tier of documentation is the policy manual. This is the document that defines what will be done and why. A quality policy manual should be written so it is clear, precise and practical, and easy to understand. The why can be stated just once as a quality policy statement. This statement should be a short, simple definition of the organization’s quality intentions. For example:

Quality is the responsibility of each Tempest employee. We pledge to continuously provide products and services that meet or exceed customer expectations.

TEMPEST INC., ST. LOUIS, MO.

The remainder of the policy manual addresses that will be done to comply with the standard being used. Another way looking at the policy manual is to think of it as the commandments of the system. Each element of the standard is addressed individually and usually requires one page of less.

Procedures

The second tier of documentation is quality procedures. These procedures describe the methods that will be used to implement and perform the stated policies. The procedures define who should perform the specific tasks, when the task should be done, and where the documentation will be made showing that task was performed.

They indicate the strategies that will be used to ensure the quality of the system. Procedures are more detailed than policies; whoever, they, too, should be written in a manner that will allow for easy understanding. It should be noted that procedures are not required for all elements. Many organizations combine the policy and procedures into one document. A procedure is needed if its absence would adversely affect the activity.

Work Instructions

Work instructions are usually department, machine, task, or product oriented an spell how a job will be done. The instructions are the most detailed of the documentation hierarchy. A work instruction may be in the form of a detailed drawing, recipe, routing sheet, specific job function ( for example, turn nut four turns clockwise), photograph, video, or simply a sample for comparison or conformity.

The writing of work instruction is best carried out by the employee who performs the task. This person knows the process and problems encountered in that process. However, a documentation specialist may needed to do actually writing. This method also creates a pride of ownership in the document, making it more likely to be carried out. Additionally, employee participation helps to ensure that future improvements will be suggested. Not every task requires a work instruction. For example, you don’t need to tell a computer specialist to turn on the PC.

Records

Records are a way of documenting that the policies, procedures, and work instructions have been followed. Records may be forms that are filled out, a stamp of approval on a product, or a signature and date on some type of document, such as routing sheet. Records are used to provide traceability of actions taken on a specific product or batch of products. They provide data for corrective actions and a way of recalling products, if necessary.

Source: Total Quality Management by Dale H. Besterfield