ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence

Ninja

Looking for Reality
Trusted Information Resource
weekly equipment preventive maintenance (PM) required by the organization
A period of weeks with no downtime on a press, for example, for equipment failure may mean it was maintained well enough to keep running.

Still missing each other...
"Maintained well enough" and "weekly equipment preventive maintenance (PM) required" are not the same...
 

Ninja

Looking for Reality
Trusted Information Resource
Well now,

In response specifically to Jim Wynne:
I just received a copy of the ISO 9001:2105 standard at home from {source).

You are correct. There is no requirement for the organization to actually follow through with it's requirements as it pertains to this thread...how odd.
7.1.3.b. requires the org. to determine the equipment, provide the equipment and maintain the equipment...but it does NOT require the org. to maintain it they way they have determined it should be maintained...

What a crock. Glad I'm not ISO anymore...what a waste of time and money.
 

Sidney Vianna

Post Responsibly
Leader
Admin
but it does NOT require the org. to maintain it they way they have determined it should be maintained...
Not sure I follow your logic. The standard stipulates that MAINTENANCE is required. The organization decides, based on the type of equipment and infrastructure the extent, frequency, type, etc... of the maintenance to be performed. So, the organization must MAINTAIN the equipment. Did you mean to say RECORDS to be maintained are not required?
 

Ninja

Looking for Reality
Trusted Information Resource
Please define "maintenance" according to the standard...specifically outside of of what the org. has determined maintenance should be...
 

Big Jim

Admin
Please define "maintenance" according to the standard...specifically outside of of what the org. has determined maintenance should be...

The standard requires that you determine, provide, and maintain the infrastructure.

ISO 9000:2015 doesn't define maintenance.

ISO 9002:2016 isn't much help either. It doesn't provide insight about maintenance other than you need to do it.

An on-line dictionary might help.

the process of maintaining or preserving someone or something, or the state of being maintained.
"crucial conditions for the maintenance of democratic government"
synonyms:
preservation · conservation · continuation · continuance · continuity · keeping up · carrying on · prolongation · perpetuation
  • the process of keeping something in good condition.
    "car maintenance" ·

    synonyms:
    upkeep · service · servicing · repair(s) · improvement · care · aftercare


 

tony s

Information Seeker
Trusted Information Resource
If in performing a weekly maintenance requires the operator/technician to perform some tasks (e.g. replenish the oil, change the filter, remove accumulated dirt, etc.), and there was no record to show that they were done, then I will need to check whether the oil level is within the acceptable level, check whether the old filter was recently replaced and check whether dirt was removed. An audit trail with the supplies issued to the operator/technician by the material custodian can support the replenishment of oil and filter change. These can serve as verifiable objective evidences for me that the weekly maintenance tasks were done.
 

Sidney Vianna

Post Responsibly
Leader
Admin
If in performing a weekly maintenance requires the operator/technician to perform some tasks (e.g. replenish the oil, change the filter, remove accumulated dirt, etc.), and there was no record to show that they were done, then I will need to check whether the oil level is within the acceptable level, check whether the old filter was recently replaced and check whether dirt was removed. An audit trail with the supplies issued to the operator/technician by the material custodian can support the replenishment of oil and filter change. These can serve as verifiable objective evidences for me that the weekly maintenance tasks were done.
:applause:well said, @tony s

Only an incompetent and lazy auditor think that evidence has to be documented somewhere via a record.
 

Danyboy32

Starting to get Involved
Don't forget 7.5.1 a & b, particularly b.

"The organization's quality management system shall include:

a) documented information required by this International Standard:

b) documented information determined by the organization as being necessary for the effectiveness of the quality management system."

So according to b, if the organization has determined that records for a particular activity is needed then it is needed and it is fair game for an auditor to go after.

In other words if the organization says in their procedures or even orally that records for maintenance including preventive maintenance are needed auditor can and do write nonconformances for it.
So if I understand correctly, you would write a nonconformity against 7.5.1 b, even if there is no evidence of lack of maintenance (according to the OP)?
 

Big Jim

Admin
So if I understand correctly, you would write a nonconformity against 7.5.1 b, even if there is no evidence of lack of maintenance (according to the OP)?

You are correct. It would not be written for the lack of maintenance, it would be written for the lack of a maintenance record. It is the old do what you say you are going to do. If you say that you are going to keep a record and don't keep a record, it's a nonconformance against your own procedure.
 

Danyboy32

Starting to get Involved
You are correct. It would not be written for the lack of maintenance, it would be written for the lack of a maintenance record. It is the old do what you say you are going to do. If you say that you are going to keep a record and don't keep a record, it's a nonconformance against your own procedure.
One hypothetical situation. This is an external third party audit and you are the Quality Manager. The audit finishes with only one nonconformance (the one that was found in the previous post, against 7.5.1 b). The external auditor writes this nonconformance. Two questions:

1. If you are the owner of the document control process, and after the root cause analysis you find that only the people in maintenance are responsible for this kind of events, who would you include in your corrective action, the entire staff or only the people in maintenance?

2. Would you consider this a good finding made by the external auditor, one that really gives value to your company?
 
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