A closer look at Quality Records

Control of Quality Records is probably one of the least glamourous sections of the ISO 9001 standard.

What the ISO 9001 standard requires: 4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
Automotive, Medical and Aerospace may have additional requirements as well.


For the typical company adhering to ISO 9001 requirements there are a variety of Quality Records which must be kept to provide evidence that the company is complying with the requirements of the standard

Electronic Record Retention
During my audits I am finding that Quality Records Tables or Master Lists of Records do not account for the electronic side of record retention. Typially sales inquiries are kept on e-mail, but we don't mention sales orders, inquiries, etc on the Quality Records Table. Or the quality records table will say that these records are kept for 2 years. Well a quick comparison to what the IT folks are regulating turns up a different story. E-mails quickly deleted after six months. Well happens as evidence of conformity if we are only keeping our records for six months.

A quick way to ensure that your Quality Records Table contains everything that the QMS standard requires is to go through the standard for each requirement and keep track of each reference that requires "records". Then double check that against your quality records table.

Confidentiality
The Quality Records Process should also include how we are going to keep information confidential. If we dispose of a computer, reformatting the hard drive - is that enough to ensure that any customer specifications or personnel records are protected? Does your organization understand that erased data on an old computer drive may still be retrievable? A report "Skeletons on your Hard Drive" by Matt Hines for CNET News.com shows that just because a hard drive was reformatted - the information can still be found. Something to consider when making computers obsolete.