ISO 9001 Clause 6.3 Infrastructure - Preventive Maintenance Requirements

[Sam4Quality]

Originally Posted by Big Jim

Just for fun, let me toss in this TC 176 interpretation. The standard requires that you determine, provide, and maintain the infrastructure . . .

How you do that is really up to you. The standard is silent. How many of you believe that maintenance records are required?

http://www.tc176.org/pdf/rfi003_final6_3.pdf

I think this topic should already be part of the following discussion thread 'What should be changed in ISO 9001:2014 standard':
http://elsmar.com/Forums/showthread.php?t=30496

Because, I firmly believe that records of maintenance need to be maintained, whether required by the standards or not! This gives a history of the actions taken on that 'infrastructure' (building, EVM, IT, etc) thus enabling to construe the future course of action.

Precisely, the same reason all of us have to maintain our medical history.
Good health maintenance!

Ciao.

_________________________
Sincerely, SAM

"""To achieve the impossible, it is precisely the unthinkable that must be thought!"""

 

[machrk]

An alternative view would be that you don't have to have a documented procedure/instruction for preventive maintenance - just have control over the process.

we are finding that we need to have more detail on preventative maintenance in our systems because of Factory Production Control (FPC) requirements in EU's CE Marking - Construction Products Directive 89/106/EEC and Singapore's Building Construction Authority's BC 1: 2008 - hence it just makes sense to build them into our original ISO 9001 QMS documentation - 1 system to cover the 3 certifications

also it will help with our EU Reach requirements

 

[bobbelden]

the TC176 web site is down does anybody have a copy of the interpretation?

 

[Crusader]

How many of you believe that maintenance records are required?

go here:
http://www.iso9001erklaert.de/ISO90.../Interpretations-Approved_Interpretations.pdf

 

[roneljdsilva]

Hey guys,
As some of you know, I am from a small machine shop manufacturing units for the oil and gas industry. In the last audit we faced, we received a finding wherein our PM procedure did not define controls. I'm new to QA (just graduated a while ago) so can any one of you shed some light on this and explain to me exactly how can we control this process?
We have checklists. But maintaining them as record isn't documented in our procedure. Will documenting it kinda close this finding? And also are these records considered quality records? API Q1 states that all quality records must be retained for a minimum period of 5 years unless otherwise specified by legal or external standards. So must my records for PM schedule and the checklists be retained for five years?

Appreciate any advice

 

[Helmut Jilling]

Hey guys,
As some of you know, I am from a small machine shop manufacturing units for the oil and gas industry. In the last audit we faced, we received a finding wherein our PM procedure did not define controls. I'm new to QA (just graduated a while ago) so can any one of you shed some light on this and explain to me exactly how can we control this process?
We have checklists. But maintaining them as record isn't documented in our procedure. Will documenting it kinda close this finding? And also are these records considered quality records? API Q1 states that all quality records must be retained for a minimum period of 5 years unless otherwise specified by legal or external standards. So must my records for PM schedule and the checklists be retained for five years?

Appreciate any advice

Please post the actual words from the finding, and the objective evidence the auditor cited. Then, perhaps we can help. This does not sound quite right.

 

[roneljdsilva]

Please post the actual words from the finding, and the objective evidence the auditor cited. Then, perhaps we can help. This does not sound quite right.

Okay here it is,
Description: A list of all equipment requiring PM that contains equipment type, ID, locations, PM frequency, and PM tasks is established and is maintained as record. The procedure for maintenance process of the machine tools and equipment does not provide adequate controls to maintain the program. The procedure only specifies that the PM is carried out and actions are taken accordingly. The current arrangement and check list does not provide adequate level on PM and in most part provides for machine appearance, rather than based on technical program. The organization shall evaluate the effectiveness of the preventive maintenance program.


Okay so I spoke with my shop supervisor and we revised the form to be a wee bit more technical but I still am in the grey about the procedure cos from what I see, it was written poorly but before revising that too, I'd like to know how exactly to control this process or in general, how does one control a process? Just by maintaining and reviewing records?

 

[Helmut Jilling]

As I suspected, it sounds like the auditor was over-reaching significantly, based perhaps on his personal views as to what maintenace should look like. Here are a few comments to consider:

ISO 9001 does not say much about maintenance. I think it would be better if it did, because it is a very important process, and TS-16949 takes it a little further, ...but the fact is ISO 9001 only says that you must have a "suitable maintenance" process or program. Obviously, that is a much lower bar, a more generic requirement.

If your maintenance process was not effective, it might open the door to an auditor writing a finding, based on the evidence that it was not effective. Examples might include high downtime, waiting for spare parts, missing delivery due to downtime. Maybe missing a lot of planned maintenance events. In those cases, the auditor should write a finding that the maintenance process was not effective and show the evidence. Otherwise, it would be much more difficult for an auditor to make the case that the process is not effective, and he should leave it alone.

If you have a list of equipment, some kind of maintenance schedule, your maintenance guys have suitable skills, and downtime is not unusually high...then your process would probably be pretty decent. Then the finding would not be fair, and should be appealed to the registrar.

It is certainly not required that you have a lot of documented procedures and documented controls and whatnot... I am not even clear what was intended by some of therms he used...too abstract.

 

[roneljdsilva]

Okay, got it! So he had no hard evidence that the PM process was ineffective but he wasn't overly impressed with the checklist we maintained and that probably did not provide a lot of control over PM, but I revised the checklist to get a lil more technical. Hopefully that should solve the problem and as for changing the procedure ( I hate doing so without a strong cause) should I add that PM is being controlled by maintaining check lists as records? That bit isn't mentioned in the procedure but I think with that being said, he can't say that we are not controlling the process.

Thanks!

 

[somashekar]

All that the standard expects you to do is to:
Determine
Provide
Maintain
The needed infrastructure.
The standard here has been so lenient that it does not ask for any requirements of records.
If there are evidences that the QMS performance is adversely effected due to lack of Maintenance of provided infrastructure, such can be audit evidences for a NC. The rest like the checklist, PM, b/d M, records, any maintenance procedures, critical parts inventory holding, etc etc ... are all your own inclusions. If you have brought them into the QMS, then please respect the same. There is no need also to document how you will perform the maintenance process either.
Post #18, says it all so well ...