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1st November 2004, 01:59 PM
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AS9100 Para 7.5.1.3 Maintained according to documented procedures...
I had a customer audit who issued a finding because they said "Per AS9100, Para 7.5.1.3, production equipment, tools and programs shall be ….maintained and inspected periodically according to documented procedures. No objective evidence is available to verify such maintenance."
Does AS9100 state that records of preventive maintenance or repair actions be maintained? Our facility is RAB Registered to AS9100B.
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1st November 2004, 04:20 PM
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What's objective versus anecdotal?
So, - Do you have written procedures and work instructions (WI) for maintenance and inspection of your stuff?
- Does your organization follow those Procedures and WI?
- If auditor asks employees where the procedures and WI are, do they answer correctly?
- If auditor asks employees if they follow the procedures and WI, do they say yes?
If all the answers are yes, that seems pretty objective to me - I see no need to cut down forests to maintain records of routine checks if no anomalies are detected.
On the other hand, it does seem prudent from a business point of view to keep a record of calibrations, replacements, or repairs versus records of periodic cleaning or lubricating of devices.
We are, after all, not talking about documenting inspection and maintenance on aircraft which brings us into the realm of government regulation.
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4th November 2004, 06:18 PM
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Actually it's talking about maintenance of production equipment, not aircraft.
The standard doesn't specifically state that you're required to have records of the maintenance activities. If they have evidence that you have improperly maintained equipment, they could definitely write it up. Other than that, they might make a case that this falls under 7.1d, which states:
Quote:
In planning product realization, the organization shall determine the following, as appropriate:
d) records needed to provide evidence that the realization processes and resulting
product meet requirements
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Does it make sense for your business to have maintenance records?
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4th November 2004, 07:21 PM
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Quote:
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Originally Posted by howste
Actually it's talking about maintenance of production equipment, not aircraft. 
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Right! I wrote:
Quote:
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We are, after all, not talking about documenting inspection and maintenance on aircraft which brings us into the realm of government regulation.
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meaning if we were talking about aircraft, we would be dealing with government regulation which takes precedence over AS9100.
Without specific ruling or contract requirement to the contrary, 7.1d only talks about documenting that the processes and products meet requirements. It seems to me that objective evidence of continued throughput of "product" which meets requirements could also be used as objective evidence that the "process" meets requirements without further documentation.
The organization is, always, the final arbiter of whether additional record-keeping (beyond statutory minimums) is necessary to meet its business systems, not a third party auditor.
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4th November 2004, 07:51 PM
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Oops, you're right. I should really read your post before I respond. I agree with your other comments as well.
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28th January 2005, 03:25 PM
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I am no expert on this subject, but I just attended a seminar called "AS9100 What an Aerospace Auditor Expects" hosted by PRI a major registrar. They went over each AS9100 element and talked about what they expect to see and what the typical nonconformances are. These comments are word for word from the seminar, hope they help For 7.5.1.3 they said
-Requires a documented procedure to implement and tool storage requirement for accountability
-Most orgainzations rely on the First Article verification alone
-Auditors expect evidence of validation and procedure coverage for identification, control, and inventory accountability
-Generally poor/marginal compliance to this requirement
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28th January 2005, 03:31 PM
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Quote:
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Originally Posted by waterdog
I am no expert on this subject, but I just attended a seminar called "AS9100 What an Aerospace Auditor Expects" hosted by PRI a major registrar. They went over each AS9100 element and talked about what they expect to see and what the typical nonconformances are. These comments are word for word from the seminar, hope they help For 7.5.1.3 they said
-Requires a documented procedure to implement and tool storage requirement for accountability
-Most orgainzations rely on the First Article verification alone
-Auditors expect evidence of validation and procedure coverage for identification, control, and inventory accountability
-Generally poor/marginal compliance to this requirement
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There's a world of difference between a documented PROCEDURE for performing maintenance and (from the first post)
No objective evidence is available to verify such maintenance."
Does AS9100 state that records of preventive maintenance or repair actions be maintained? Our facility is RAB Registered to AS9100B.
which implied the auditor was looking for RECORDS that the PROCEDURE had been followed, which goes beyond the requirement.
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28th January 2005, 08:13 PM
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Clause 7.5.1.3 of AS9100 requires specifically that there be a documented procedure addressing control of production equipment, tools and NC Machine Programs. Additionally the clause contains requirements for validation actions, verification actions and periodic preservation and condition checks of the reference items in storage.
During audits it has become clear to me that organizations who implemented the standard do not understand that there are specific words with defined meanings that are auditable. Specific to this clause there are four key works that contain requirements as defined by ISO 9000. They are:
Documented procedure. Written procedure, there must be one addressing requirements of 7.5.1.3.
Validate/Validations. The organization must confirm through objective evidence that requirements of specific intended use or application have been fulfilled.
Verification. Again the organization must confirm through objective evidence that specific requirements have been meet.
and
Objective evidence. Is the data supporting the existence or verity of something. In this case would be related to the required validations, verifications and first articles required by 7.5.1.3 and NC program (AKA software) revision data/records.
Without being there my guess would be the auditor was looking for the supporting data that the required validations, verifications, first articles, and preservation checks were completed and you could not supply the this data to the auditor. Most companies would defaulted to the use of hard copy records to meet this requirement.
Jeff
Last edited by Jeff Frost; 28th January 2005 at 08:27 PM.
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