Audit Readiness/Sillyness

[Sean Kelley]

Perfectly acceptable as long as the paper copies are not being used without first checking against the current controlled copy. Easy for an auditor do determine whether employees do this or not by asking a few. If it is not common practice it will be evident.

 

[db]

Perfectly acceptable as long as the paper copies are not being used without first checking against the current controlled copy. Easy for an auditor do determine whether employees do this or not by asking a few. If it is not common practice it will be evident.

And then they would not be "for reference only". They would be documents used in a controlled manner.

 

[Randy Stewart]

Wallyowally,
Our system has been operating with the "All Printed Copies are Uncontrolled" for 3 years now. We have not received a NC on our doc control for that to date. We started with CAD is Master for prints 5 years ago and rolled that into our procedures and work instructions.
Most of your doc ctrl software is a big waste of money, you can control it with a simple database (we use Access) and most work processing programs.
It all comes down to how you have defined your system. Remember that Document Control is to prohibit INADVERTANT use of outdated procedures, etc. So that is what needs to be focused on. There are numerous ways to do that and it doesn't have to be in controlling distribution. Most documents don't have TOP SECRET stamped on them or are of national security measures. You just don't want people to use old versions. That can be as easy as "I ask my supervisor" before use.

 

[RoxaneB]

Wallyowally,
Our system has been operating with the "All Printed Copies are Uncontrolled" for 3 years now. We have not received a NC on our doc control for that to date. We started with CAD is Master for prints 5 years ago and rolled that into our procedures and work instructions.

Randy, you're my hero! Our system is similar to yours and we, too, have had no problems with it. Where the breakdown can potential occur with companies pursuing this route is in discipline/training. It's all fine and dandy to say that printed copies are uncontrolled but the employees have to believe in that process *and* follow it.

Humans are, by nature, a lazy species. Yours Truly will even prefer to lean over and grab the hard copy I printed off two weeks ago versus going into the computer system to find it...and this is the process that I'm responsible for maintaining!

Time, training, and adherence to the process are needed to ensure that all employees get onboard with the idea that only electronic copies are controlled...but it *is* doable.

 

[CINDY]

We too control all documents electronically. It works great. We state that all printed documents are uncontrolled. When the document is printed the footer indicates "uncontrolled copy". I have one printed reference that is attached to the form we use for authorization signatures and then it is filed away.

The database is used to track all documents. We made our own database and included all items we wanted to track including CAR's, CI's, Audits, etc. This is also used on an annual basis for trends. I have years of history stored.

The quality policy means nothing if its meaning is only in reference to repeated words. How each individual contributes to the policy and goals is much more useful.

Cindy

 

[Randy Stewart]

Randy, you're my hero!

Thanks for the compliment, but it's just that great minds think alike! Right CINDY????

It took us awhile to come to this type of control but as a system matures you can see things that will help streamline. This was one of the big ones for us.

With all of the standards you MUST look at what is the intent. Ask your auditor or someone "What are they trying to do". Look at the definitions, compare the 2 and see what fits for you and your system.

 

[Aaron Lupo]

Hi all,

I'm new here. What a great place, the information abounds!

I haven't been audited for several years so I have a question if certain practices still exist. I considered these some of the silly parts of ISO 9000.

1. Quality Policies: Is is still required/preferred for all employees to memorize the policy? I just can't do the little plastic card thing as it seems too fake/hokey for me.

2. "For reference only". If the QMS is online, is it still necessary to write "For reference only" on all printed documents? At my last company this was a little exercise we did before each audit and it made the auditor happy.

Thanks,

Wally

#1 I do not find it fake or hokey in anyway, in fact when I do audits if they do not have a card with the QP on it it darn well better be tattoed on their form if not I become very angry and irrate and beging throwing chairs or whatever I can get my hands on at the moment.

#2 If your QMS is on-line you need to be able to show restricted access, I would also expect to see "For reference only" written in blood on every hard copy anything less and I start throwing things again!

I hope you know I am just kidding of course! If any auditor asks an employee to tell them the QP word for word they really need to have additional training. Do auditors still ask people to tell it to them word for word???

As far as your system being on-line and the whole for reference only if you state it in your Doc Control procedure that printed copies are for ref only you should be covered.