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View Full Version : ISO 9001 and Controlled Forms


somerqc
9th November 2005, 03:38 PM
Hi all,

I am currently developing an ISO 9001 system for my employer. Since we are a custom facility, we are constantly having to obtain approval from our various clients.

We currently have an "Approved Sample" label that is used for internal sample control (i.e. have authorized personnel sign off on 1st offs, prototype samples, etc.).

I would like to expand this sample to the client approval process (Pre-ISO, this was usually done verbally....:mg: )

Since we will be requiring written approval from the client, I was wondering if I would need to control a 2nd form (i.e. a standard fax form that is identical to the current label) or if I could just control the one form but acknowledge that the same form may be in fax form where we do not have face-to-face interaction with the client

D.Scott
9th November 2005, 04:07 PM
You can define what needs to be controlled in your system and the extent of control you have. If you already have a controlled form, I see no need for another. Just add the fax allowance to suit what works for you.

In developing your forms and QMS, think about what works best for your company. Be careful you don't "over-control" yourself and end up painting yourself into a corner. Be very careful with absolutes. If you require written approval from the customer, what happens to the "rush order" that eventually will turn up? How about the phone call from the customer to your president asking for an exception? What happens if the fax isn't working?

My point is, I understand you want to cover yourself on approvals but you have gone for years accepting verbal approval. There is no requirement that approval must be written (other than your own requirement). If your procedure says "ALL" and one is found without written approval, you have a N/C. Why not make it so it works for you and accept either written or verbal with written being the preferred method. You could state that when written approval cannot be obtained, verbal approval is acceptable as long as the approving persons name and title were noted on the form and signed by your employee who got the approval. When it comes to meeting the requirements, meet them in the way that best fits your company and by all means, keep it simple.

Dave

pilchard
9th November 2005, 04:16 PM
Usually if you control a form as a document the form usually ends up as a record so you have controlled it twice.

somerqc
9th November 2005, 04:40 PM
We actually allow the salesperson to approve a sample in c/o the client in cases where either a verbal approval, e-mail approval, or off-site meeting with client resulted in approval.

Thanks - I was hoping I could get away with just allowing for the current form to be used in fax form as well.

ARGH - my last system had a 4-page quality manual with references to all the other procedures/work instructions on within the 4 page manual. This one is 40 pages due to the culture (i.e. It isn't written, so I don't have to do it)

Oh well - at least in this case I can save part of a tree.

Crusader
27th March 2006, 01:07 PM
Usually if you control a form as a document the form usually ends up as a record so you have controlled it twice.

We were written up in an audit because the document(informal form) that was being used to capture warranty returns analysis information was not a controlled form. So, we had to assign a control number and put it under doc control. I have seen this go both ways in audits and it's frustrating! :frust: