Does overdue preventive maintenance require an evaluation on product quality?

[senna miller]

ISO 13485 6.3 states 'The organization shall establish documented requirements for maintenance activities, including
their frequency, when such activities or lack thereof can affect product quality.'

The guideline also states that 'Maintenance should be carried out on schedule.'

So does this mean that if you have developed preventive maintenance schedules, and they are not carried out per that schedule (i.e. they are overdue) you should assess whether there has been a possible impact on product quality?

 

[Sidney Vianna]

Re: Does overdue preventive maintenance require an evluation on propduct quality?

So does this mean that if you have developed preventive maintenance schedules, and they are not carried out per that schedule (i.e. they are overdue) you should assess whether there has been a possible impact on product quality?

If your product was verified for conformity, downstream of the equipment in question, it seems unnecessary to have this assessment done, in my opinion.

From a common sense perspective, the only justification for this assessment would be in cases where the process is so automated and, due to extreme high process capability, no human verification of product conformity exists. So, you could have effectively shipped non-conforming products, unknowingly. But I doubt that would be the case here.

 

[Qualqueen]

Re: Does overdue preventive maintenance require an evluation on product quality?

ISO 13485 6.3 states 'The organization shall establish documented requirements for maintenance activities, including
their frequency, when such activities or lack thereof can affect product quality.'

The guideline also states that 'Maintenance should be carried out on schedule.'

So does this mean that if you have developed preventive maintenance schedules, and they are not carried out per that schedule (i.e. they are overdue) you should assess whether there has been a possible impact on product quality?

IMO it's not a requirement but I believe it should be done. It also depends on what equipment and how it reflects on the final product. We're 13485 also and one of our customers always has me add to a SCAR that there was no adverse affect on final product due to any changes or whatever was done.
What you do need to do is a Corrective action. Root cause..Corrective action taken...verification of effectiveness..I'm sure you know the drill

 

[yodon]

Re: Does overdue preventive maintenance require an evluation on product quality?

Concur with all the replies so far. I would add that, as part of your CA activities, assess the potential for quality impact on the product. That shows you considered the potential and provides justification for taking no action (presuming that's the case).

 

[arios]

I agree with the other folks. It will depend on the type of equipment and potential impact for not doing the PM on time.

This scenario would be a good item to consider in your risk assessment (like an in a process FMEA), and determine in advance how significant would it be to miss a PM date and the necessary follow-up actions if they are relevant which may include an assessment for quality or may be just a more detailed equipment check on the next PM routine.

On the other hand, make sure your PM program prevents this situation from happening. Prevention is always better.

 

[gholland]

Arios is on the right track. Your pFMEA may have some risk control measures that are related to the missing PMs. If your pFMEA isn't done or doesn't consider PMs you might wish to document a technical review with the appropriate engineers and discuss what impact missing the PMs may cause. If the decision is 'no impact' then you should document that decision with your rationale so if someone with regulatory authority asks you how you know the product is good you can point to this review.