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.

Social Media

I am wondering how our use of social media relates to the better mousetrap theory. Build it and they will come - (the customers of course). Yesterday, I have been working with the web designer, newsletter designer, twitter, etc, and I am on social media overload. Yesterday I checked my competitors key words to see what they are using and they all seem to be clueless, which is strange because their sites rank sometimes better than mine.

Linked in
My favorite media so far is linked in, my only gripe about that is when marketing types add discussions which are basically SPAM. So instead of SPAM in my e-mail I get SPAM in my groups. So I am ready for someone to design a SPAM filter for social media. Linked In Spammers have no clue on building a reputation or networking. I quit my local linked in group because a realter would spam me everytime he had a listing. Am I missing anything when I left? I am not sure. All I know is that I am NOT missing any real estate listings.

So what are your thoughts? Are we relying on Social Media too much? Or is it another tool to communicate and establish relationships with potential customers.

Somestimes fixing the problem is more important that what you label it

Somestimes fixing the problem is more important that what you label it

I received a call from a client today having trouble with root cause analysis for a non-conformance I wrote regarding "No defined frequency for Product Audits". To satisfy that requirement in TS 16949 I would expect to see a schedule or a paragraph in the procedure which talks about how often/when/etc.

Because TS breaks out Product Audits separately, the procedure referring QMS audits are done at least once per year didn't cover the topic Product Audits so a NC was issued during the audit. Not a major deal; something that can be address easily.

You say Tomato - I say To-Mat-O

After talking to my client we decided to call it an opportunity for improvement, clearing the way to get passed the root cause analysis and fix the issue.

It was a simple problem which can be corrected easily. We skipped the root cause analysis for this, and sometimes that is ok. Not for the big stuff though.

I call it: Common Sense Auditing. What are you thoughts?