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Procedure binding even if not required by the standard - Where's the requirement?

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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#53
RCBeyette said:
At the end of the day, I think most of us would agree with the philosophy of "why write it if you're not going to do it", but unfortunately, a Note and its corresponding "should" are not auditable.
I agree the "should" is not auditable. However, in my view if the organization makes a procedure and places it in the QMS, the procedure is auditable--even if it (or everything within it) wasn't specifically required--not among the Needed Six.

This is why I advocate simplicity where possible--better not to make what I call an audit swamp. Don't make claims to a bunch of stuff that won't happen.
 

RoxaneB

Super Moderator
Super Moderator
#54
Jennifer Kirley said:
This is why I advocate simplicity where possible--better not to make what I call an audit swamp. Don't make claims to a bunch of stuff that won't happen.
I know what you mean. I used to refer to organizations which had lovely documented systems but didn't do a darn thing on them and then couldn't figure out why (a) their system didn't work and (b) they didn't get the piece of paper on the wall.

I say we tie this issue into 5.5.1 "Responsibility and authority" by stating 'The organization has not defined the responsibility of employees regarding the adherence to documented processes.'

Do we have a 'stirring-the-pot' emoticon? :)
 
#55
Interesting question and discussion. Time for a summary before we go on?

In the OP, mirrorcrax asked:

mirrorcrax said:
usually organizations have several procedures that exceed ól 9001's requirements with details related to their business, however, which clause do you think says that once a procedure is developed by the organizationit becomes binding even if not required by the standard, i think the closest is 4.1
As far as I can see, the following answers have come up: 4.1, 4.1f, 4.2.1d, 4.2.1 note1, 4.2.3, 5.5.1 and finally 8.2.2b. But wait: Let's go back to the original question: Exceeding the std requirements?

I feel like adding another twist to this discussion: 4.1d requires us to ensure the availability of resources and information necessary to support the operation and monitoring of our processes. If an organization has turned out a procedure, perhaps we can assume that they consider it necessary information... I suppose a procedure, written or not, must be considered to be such information and thereby have to be implemented? If so, how can we go beyond the requirements of the std? :naughty:

/Claes
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#57
Claes Gefvenberg said:
I feel like adding another twist to this discussion: 4.1d requires us to ensure the availability of resources and information necessary to support the operation and monitoring of our processes. If an organization has turned out a procedure, perhaps we can assume that they consider it necessary information... I suppose a procedure, written or not, must be considered to be such information and thereby have to be implemented? If so, how can we go beyond the requirements of the std? :naughty:/Claes
I think this comes close to what I was trying to say, but you said it better. :agree:
 
D

delawarebill

#58
I look at it this way...

If you have a procedure established and documented, essentially you are telling your customer that this is the way that you perform (insert procedure here). To do something different would be dishonest at least... probably criminal in some cases.

4.2.1 of AS9100B has the following note

"NOTE 1: Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained."
 
V

vanputten

#59
I think the following clauses may say that once a procedure is developed by the organization, it becomes binding.

4.1(a) – (f); 5.5.2(a); 5.6.3(a); 6.1(a); 4.2.1(d);
 
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