ABSTRACT
A whole group of documents tell how things occur on a regular basis. It’s safe to say, however, that each company may have a different setup for its master “how to” documents. Many companies have a flat document structure, with every “how to” document a standard operating procedure (SOP). Many other companies tier their documents with a quality policy at the top that tells of the firm’s adherence to quality standards overall. Then, in the next tier, they put SOPs in place to delineate systems and processes that drive the business. Such systems and processes are “big picture” documents that define overall activities such as metrology of instruments and equipment. Next in line are instructions for carrying out specific procedures — activities that one or two people can perform, such as calibrating a scale or verifying temperature in a freezer or refrigerator. On a par with instructions are laboratory methods — documents that tell how certain regularly conducted experimental activities occur. At the base of the tier structure are support documents that result from the defined activities. Forms working in tandem with SOPs and instructions, for instance, capture data as systems and processes occur. Data collection in turn feeds into process reports and ultimately summary reports. This tier structure has been adopted by many companies complying with the regulations for medical devices, 21 CFR Part 820, and the International Organisation for Standardization (ISO). The reasoning is that the Food and Drug Administration (FDA) inspectors conduct inspections by a “top-down” method structured as the Quality System Inspection Technique (QSIT), so the top documents should present the “big picture.” Companies then need only produce those documents that are required for the inspection; they don’t need to make every document available unless asked. Companies that are ISO compliant also adhere to a top-
down document organization, since ISO requires a quality policy to be in place.
