Tuesday, March 31, 2009

Document Records, and Data Control

Document and Data Control (SOP 42-02) establishes a standard procedure for controlling documents and data and to assure that only valid information is available for use. Documents and data applies to all information manually or electronically recorded that describe attributes of the quality system. Form 42-1, Master Document List is a documentation aid to help a company keep track of documents currently available.

Change Control (SOP 42-03) is intended to establish a standard method for initiating and changing documents affecting the quality system. Use Form 42-2, Change Control Record for initiating and changing quality system documentation.

Proper Documentation Practices (SOP 42-04) is intended to establish a standard procedure for properly documenting information. Good record keeping practices are necessary since records are usually the only means to assure compliance to ISO.

Control of Quality Records (SOP 42-05) establishes a standard method for identification, collection, and storing quality records. Quality records absolutely must be accurate, legible, and stored in a permanent medium. Also, when asked for a given quality record, you should be able to produce the record within 5 - 30 minutes. Unwarranted delays cast doubt on the document retrieval process. No form is provided for this section.

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