Audit Scenario – Control of Documents
By Lynn Clyde, BRC Quality Consultant
The following is a typical auditing scenario that might be found when auditing an ISO 9001:2008 quality management system for clause 4.2.3 Control of documents. Read the scenario to determine if you think it would be conforming or nonconforming, then read the answer and explanation.
Support Information – ISO 9001:2008 Clause 4.2.3
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed:
a) To approve documents for adequacy prior to issue,
b) To review and update as necessary and re-approve documents,
c) To ensure that changes and the current revision status of documents are identified,
d) To ensure that relevant versions of applicable documents are available at points of use,
e) To ensure that documents remain legible and readily identifiable,
f) To ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the Quality Management System are identified and their distribution controlled, and
g) To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
A production employee was being audited and the auditor noticed a work instruction on the employee’s bench. The auditor looked up the latest version of the work instruction and found out that the copy on the bench was not the most current version. The employee said that she did not use that work instruction and it belonged in another area, and so it did not matter that it was out of date.
Nonconforming to clause 4.2.3 Control of Documents.
Clause d) states “that relevant versions of applicable documents are available at points of use”. All controlled documents (work instructions or procedures) that are used to perform work must be the most current version and must be available in the location (point of use) where the work is being done. Note: If it had been the most current version and belonged to another area, it would not have been considered a non-conformance, as long as the workers in the other area had access to the instruction.