How to cope with the validation of processes - Services

[sszymanski]

Hi all,
I have been working on implementation 9k:2k in facilities management company. Our services are technical maintenance , cleaning and receptions.

My question is how to cope with the validation of processes.
We do technical maintenance in accordance with Standard Operating Procedure for each system/instalation in the builiding. This instructions are mainly prepared in accordance with producer's manuals and instructions.

What is your opinion on that matter ?
regards
s.szymanski

 

[Al Rosen]

Hi all,
I have been working on implementation 9k:2k in facilities management company. Our services are technical maintenance , cleaning and receptions.

My question is how to cope with the validation of processes.
We do technical maintenance in accordance with Standard Operating Procedure for each system/instalation in the builiding. This instructions are mainly prepared in accordance with producer's manuals and instructions.

What is your opinion on that matter ?
regards
s.szymanski

I may be wrong, but I always interpreted this as validation of processes that could not be verified through normal inspection and verification of the end product, or required destructive testing. Of course this is within the context of a manufacturing process. I'm not sure what specific proceses would be similar in your application. When you refer to technical maintenance, what is a specific process. Is it like changing the oil or spark plugs periodically on an automobile? Could you show that this increased the life of the engine or improved its performance?

 

[sszymanski]

Our technical maintenance consists of two subprocesses : Preventative Maintenance and Reactive maintenance.
Preventative maintenance is done in accordance with annual plan and operating manuals. Reactive maintenance includes all repairs on request.

I can't check the results of preventative maintenance. It is done in accordance with manual, standards, or law regulations. My question is if I can exclude validation in such case ?

For reactive maintenance, the situation is clear, because after repair it is clearly seen if the problem was eliminated or not.
s.szymanski

 

[Al Rosen]

I can't check the results of preventative maintenance. It is done in accordance with manual, standards, or law regulations. My question is if I can exclude validation in such case ? s.szymanski

You could argue that the PM being performed was recommended or mandated by the manufacturers manual, standards or regulation and that the validation was done by those bodies. I'm sorry, but I haven't had experience with this, maybe someone else has and can offer another suggestion.

 

[Al Dyer]

For validation you might want to look at customer visits or recallsAl...

 

[howste]

I don't believe you have to prove that the preventive maintenance increases life or performance. If the customer specified the maintenance to be done, all you have to do is show that you did what you had planned. If you can do that through inspection (visual or other), then you don't need to validate the process.

 

[Govind]

s.szymanski,
I was not hesitant to offer a 4 star rating for this thread. This thread brings up an interesting spin on interpretation of Validation of processes for production and services.(7.5.2).

I was mainly sucked in because of couple of points:
s.szymanski said:
I can't check the results of preventative maintenance. It is done in accordance with manual, standards, or law regulations. My question is if I can exclude validation in such case ?

Here are my thoughts:
For processes like heat treatment, painting, coating, epoxy bonding the characteristics like Hardness, adhesiveness or bonding strength can only be checked by destructive testing. This is where meeting the requirements 7.5.2 a to e ensures that the variables that affect process quality is adequately controlled and monitored.

s.szymanski has a very valid argument based on preventive maintenance. If the maintenance process includes examples of special processes mentioned above, then Yes, items a to e is very much applicable. If it is a replacement of parts, lubrication, balancing,etc where the output quality can be verified by smooth functioning of the equipment in the Test Rig, I don't think, we should apply the special process clause.

For Howste reply:
"I don't believe you have to prove that the preventive maintenance increases life or performance.".
He is correct.
He is taking me back to my ASQ CRE Exam body of knowledge- Reliability Centered Maintenance. s.szymanski, try to review books, web references on this topic.
If the preventative maintenance is not conducted at the appropriate stage of the equipment life cycle, PM will not have any effect on the life of the equipment.It will just increase the maintenance cost.
You may find this link interesting:
(broken link removed)
Regards,
Govind.