ISO 9001 Clause 6.3 Infrastructure

Haddad9921

Starting to get Involved
#1
Hi,
I am looking to simplify what we do and the records we keep
Do we have to keep records of preventive maintenance? Preventive maintenanceis not a required records by ISO 9001 but the auditor said that we have to keeprecords of PM to show that we did them.
Any thoughts?

Thank you
 
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PaulJSmith

#2
First, you only need to keep such records if you have a procedure which says you need to keep records. As for your auditor, you might ask them to "show you the shall" which states that.

As for whether or not you should keep those records, that's another matter entirely.
 

Haddad9921

Starting to get Involved
#3
So if I don't have an internal procedure for preventive maintenance, then I don't have to keep records or a PM log at all? I like the idea of asking the auditor to show me the Shall".
 

John Broomfield

Staff member
Super Moderator
#4
Haddad,

Your organization is investing in PM so machines do not unexpectedly breakdown. The consequences of an unexpected breakdown may cause your organization to not to fulfill your customer's requirements.

If so, your organization needs to monitor the PM processes but only to maintain documented information to the extent necessary for effective planning, operation, control and improvement.

John
 

Big Jim

Super Moderator
#5
More specifically, record keeping is not attached to clause 6.3. It is easy to see an example of a clause that does have record keeping attacked by looking right above it in 6.2.2.

Further, TC-176, the committee that wrote and governs the interpretation of the standard specifically says that records are not required.

Do a google search for TC-176 and look it up for yourself, and present it to your terribly uninformed auditor.

What's really frustrating is that some certification body executive committee members are not aware of this and consider maintenance records as a requirement until the are confronted the the TC-176 ruling.

The auditor is WRONG and best of luck with getting him straightened out.
 
Last edited:
P

pldey42

#6
I think this may be an example of trying to shoot yourself in the foot by only doing the bare minimum required to meet the requirements of the standard.

4.2.1.d requires "documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes."

Such records will surely include preventive maintenance records.

If a machine needs regular PM and you don't record the date it was done, how do you know when it's next due?

If software needs patches or updates (which it always does) and you don't record them, how do you know that current patch status on all relevant machines is as it should be?

If there are returns from the field and root cause analysis indicates a manufacturing fault, and you don't have the relevant preventive maintenance records, how do you eliminate lack of PM as a possible root cause?

No, they're not mandatory. But why not ask which PM records would be helpful?

Why not engage the auditor in a conversation of mutual respect and ask what he or she is looking for? Sure, they're not supposed to give advice. (Did the auditor actually say, "keep PM records," or just ask if you had considered them? If the latter, it's not advice, it's a question that's designed to help you reflect.)

But suppose the auditor has been looking at nonconforming product and its data, and wondered about preventive maintenance of critical machines, and couldn't find any? Why wait until his or her next visit to discover that you haven't met 4.2.1.d with regard to ineffective root cause analysis of manufacturing faults due to lack of preventive maintenance records?

Hope this helps
Pat
 
#7
Another way of looking at this is to say go right ahead. Simplify an already simple task and stop keeping records. Then, sit back and wait, basking in the knowledge that you, alone, have saved possibly 5 minutes per pm.

Now, once the lack of effective record keeping then starts to lead to breakdowns and lost time, which far exceed the time to complete the records, feel free to come back and ask who agreed to this simplification of the wrong task...:popcorn::rolleyes:
 
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