Preventive Maintenance Requirements - ISO 9001

[ganglai]

Our next audit on quality system is coming this June or July. It is a triennial reassessment. Not quite clear what are they going to audit on the preventive maintenance.

In our current system procedure- level 2 docs, there is a procedure for preventive maintenance. And last internal audit noted that corrective action is required to update the procedure with current practice. Non-conformances are “maintained on basis of knowledge of processes / past experience”, not based on “review of records, with specific attention being directed towards the most frequency failure mode and the most frequency process / equipment failure type” as cited on the procedure; “have been minor rectification/update of existing equipment - no plans demonstrating rectification and improvement programs”.

The procedure was written a few years before, and I believe it is based on the QS 9000. What should we do for this ISO 9001 audit? Change the procedure? We are certified to ISO 9001 not QS 9000, but we make product for automotive industry. What are they going to audit on preventive maintenance activities?

Anyone has any advice. Thanks.

 

[Viki N.]

What are they going to audit on preventive maintenance activities?

In my experience with auditors, they typically note equipment in use as they are auditing and then ask for the preventive maintenance schedules for that equipment. They then will ask to see evidence that the PM was completed as scheduled. There is no required documented procedure.

So basically you have to:

• Identify equipment (process/building/utilities/support services) that need PM to achieve conformity to product requirements
• Determine and define the methods of PM (usually detailed by manufacturer of equip. in user manuals)
• Determine & define frequencies of PM (usually detailed by manufacturer of equip. in user manuals)
• Provide evidence (records) that PM's were done per schedule & method

Hope this helps somewhat.
Viki

 

[Justin]

In my experience with auditors, they typically note equipment in use as they are auditing and then ask for the preventive maintenance schedules for that equipment. They then will ask to see evidence that the PM was completed as scheduled. There is no required documented procedure.

Viki

The "Shall" is in 4.2 Documentation Requirements: Documentation shall include (d) Documents needed by the organization to ensure the effective planning, operation and control of its processes and 6.3 Infrastructure: Organization shall provide and maintain.... and 6.4 Work Environment: Organization shall determine and manage work environment...

which will then lead you to do the following

So basically you have to:

• Identify equipment (process/building/utilities/support services) that need PM to achieve conformity to product requirements
• Determine and define the methods of PM (usually detailed by manufacturer of equip. in user manuals)
• Determine & define frequencies of PM (usually detailed by manufacturer of equip. in user manuals)
• Provide evidence (records) that PM's were done per schedule & method

Hope this helps somewhat.
Viki

Which will then lead into a documented procedure with evidence(records) of compliance. PM is often overlooked and most often the cause of production downtime due to a lack thereof.

Seems to me the standard clearly calls out for a documented procedure for preventive maintenance. I have found that using process manuals, which contain all the needed procedures and forms, ie work instructions, daily records, preventive maintenance schedule, etc.. lends to keeping things nice and tidy and readily available for employees, management and auditors especially.

Looks like your on the right track.

 

[ganglai]

Thanks Viki and Justin. I have got a quite clear ideal of what are the auditors going to look at the PM.

The above are done expect “PM was completed as scheduled”. Last internal audit showing some months are overloaded.

For the requirements in QS 9000, such as predictive maintenance, evaluating and improving maintenance objectives. At least the auditees were not successful in interpreting that anything was done to improve PM. Is there any benefit if we leave them in the procedure to be as a goal for later on?

 

[Viki N.]

Hi Justin,

I agree that in most cases a procedure is established for PM and many other areas of the Standard, but they are not required. In fact, our organization has many including PM. However, the Standard clearly states the need for documented procedures in certain clauses only (a documented procedure shall be established...) e.g. 4.2.3 and 4.2.4. It does seem easier though to create a general procedure for guidance and compliance to the Standard.

Ganglai,

As to your question about leaving goals in the PM procedure for later....
I am not familiar with QS 9000, but there is never anything wrong with having goals or objectives for improvement of processes. The only thing is that the auditors will look for some type of activity, and records of, if you state it in your procedure. This activity could be moved and included in several other areas of the Standard if you won't be actually "doing what you say" for awhile. For instance: 5.4.1 Quality Objectives, 8.5.1 Continual Improvement, 8.4 Analysis of Data, etc.

Have a good weekend, both of you.
Viki

 

[michelle8075]

Non-conformances are “maintained on basis of knowledge of processes / past experience”, not based on “review of records, with specific attention being directed towards the most frequency failure mode and the most frequency process / equipment failure type” as cited on the procedure; “have been minor rectification/update of existing equipment - no plans demonstrating rectification and improvement programs”.

The procedure was written a few years before, and I believe it is based on the QS 9000. What should we do for this ISO 9001 audit? Change the procedure? We are certified to ISO 9001 not QS 9000, but we make product for automotive industry. What are they going to audit on preventive maintenance activities?

Anyone has any advice. Thanks.

Hi There!
First off, let me say I agree with Vicki's post above. I would also say yes, update the procedure to ensure that what you are doing is what you say in your procedure. However, do not miss out on any requirements of the standard by omitting things that you should not.

I too went from QS-9000 TE to 9K2K. I did keep the preventive/predictive maintenance procedure as it was, but made it a work instruction. Per 9K2K you still have to assure the use of suitable equipment (7.5.1 c) under controlled conditions. How your company wants to meet this criteria is up to you. But be careful as a result of not performing preventive/predictive maintenance on machinery may produce nonconforming material. Which can lead to a number of other noncoformities both minor and major. Another reason we stayed with the same procedure was that we were already used to doing it, and it's provided us with suitable equipment to produce our product.

From what I understand, your internal audit found that preventative maintenance activities were basically "memories" from your maintenance staff, rather than having records of preventative maintenance happening? If that was the case... you do need records as it's fundamental to any quality system. I would confidently say that no auditor would be happy and create a minor if you said such important records were just recollections.

Good luck with your upcoming re-assessment!

 

[Helmut Jilling]

However, the Standard clearly states the need for documented procedures in certain clauses only (a documented procedure shall be established...) e.g. 4.2.3 and 4.2.4. It does seem easier though to create a general procedure for guidance and compliance to the Standard.

I strongly disagree. The standard spells out 6 procedures which are required by the standard(cl 4.2.1.c), PLUS, any additional documents you decide you need to control your processes (cl 4.2.1.d).

There is a comma between item C and D. Few companies would ahve adequate controls with only the 6, and it is a distortion of the standard to suggest that is the requirement. I think we should stop stating it as such. However, the standard does grant flexibility as to whether those documents be procedures, work instructions, or whatever.

It would be foolish to contend that a procedure for doc control is more important to effective operations than documents which define and control our production processes.

The intent was flexibility, not elimination.

 

[ganglai]

Hi There!

I too went from QS-9000 TE to 9K2K. I did keep the preventive/predictive maintenance procedure as it was, but made it a work instruction. Per 9K2K you still have to assure the use of suitable equipment (7.5.1 c) under controlled conditions. How your company wants to meet this criteria is up to you. But be careful as a result of not performing preventive/predictive maintenance on machinery may produce nonconforming material. Which can lead to a number of other noncoformities both minor and major. Another reason we stayed with the same procedure was that we were already used to doing it, and it's provided us with suitable equipment to produce our product.

From what I understand, your internal audit found that preventative maintenance activities were basically "memories" from your maintenance staff, rather than having records of preventative maintenance happening? If that was the case... you do need records as it's fundamental to any quality system. I would confidently say that no auditor would be happy and create a minor if you said such important records were just recollections.

Good luck with your upcoming re-assessment!

Thanks. I think I will do the same- make it as a work instruction.

We do some prentive maitenance and keep the records. But all of them from whate have been scheduled.

Today, I had a talk with our process tech. And I put my question in a very specific way. "Are you doing records review?..." And I found out we are somehow doing what is been asked from the procedure. So I think it very much depends on how the auditee interprets what he is doing.

 

[Viki N.]

I strongly disagree. The standard spells out 6 procedures which are required by the standard(cl 4.2.1.c), PLUS, any additional documents you decide you need to control your processes (cl 4.2.1.d).

There is a comma between item C and D. Few companies would ahve adequate controls with only the 6, and it is a distortion of the standard to suggest that is the requirement. I think we should stop stating it as such. However, the standard does grant flexibility as to whether those documents be procedures, work instructions, or whatever.

It would be foolish to contend that a procedure for doc control is more important to effective operations than documents which define and control our production processes.

The intent was flexibility, not elimination.

I must not have made myself very clear. Sorry.

I do agree whole-heartedly with you about "needed documents" to define and control of all processes. I was just stating, as you did, the need for "certain (six) documented procedures required by the standard." My reference to "doc control procedures" were just an example of how the requirement is stated within the Standard. How an organization decides what other documents are needed, would certainly be up to them (flexibility). And by no means, I didn't intend my response to suggest that the required procedures were the only ones an organization needed to have.

In our company, we have many documented procedures, work instructions, worksheets, forms, etc. which control our processes, as well as statements and document references in our Quality Manual for each clause.

Hope this helps clear up any misunderstandings of my last post.
Thanks for pointing it out.

Viki

 

[Ettore]

Re: Seek advice on preventive maintenance under ISO 9001

The "Shall" is in 4.2 Documentation Requirements: Documentation shall include (d) Documents needed by the organization to ensure the effective planning, operation and control of its processes and 6.3 Infrastructure: Organization shall provide and maintain.... and 6.4 Work Environment: Organization shall determine and manage work environment...

Our quality system is in compliance with ISO TS 16949 but we are only ISO 9001 certificated.
If in internal Audit we have a non conformity on maintenance we should address it to process 6.3 or 7.5 (7.5.1.4/5)?