Unscheduled Maintenance - Product Impact when a machine goes down

[saratogasix]

I know I am a little late to the party and this is an old thread but i am writing an unscheduled maintenance procedure right now. The requirement for unscheduled maintenance is embedded in the validation element of the standard. If you have a validated process and something happens to the asset that is involved in that process then you need to evauate the impact and decide between verification or revalidation.

I don't believe that the NCMR process is the right area to capture this info because as of yet you have not had a non-conformity. If the unscheduled maintenance is the result of an NC then by all means use the NCMR to capture data.

We have processses that are running within conformance but require maintenance. A hose is leaking, a pressure gauge stops functioning, etc. In these cases I am employing an Excursion Report. This requires production and/or QE to assess the product that was produced on the machine prior to the UM for conformity. Failing product would revert to NCMR. If the product is good then after the repair they determine and evaluate the effectiveness of the repair. Then the initial product produced after a successful repair is again verified to be within compliance of the specifications.

We would then track the excursions on each asset and adjust our PM schedule to keep the UM down. This seperates the systems and allows us to trend and track true NC's seperately from maintenance issues and allows us to track machinery for replacement.

Hope this helps.

[gholland]

We recently had an internal audit conducted by an ex-FDA investigator. Her feedback was that unscheduled maintenance triggers an NCMR. The 'material' in 'non conforming material' includes not only the product but the process and tools that are used to make the product. I believe the ISO 13485 reference was to section 7.1 or 7.5.1... because the process does not conform to your requirements the material produced was made by a non-conforming process therefore a documented disposition needs to be made on the product.

This was new to us and we're reviewing the impact to our processes... anyone else hear of this interpretation?

[saratogasix]

Gholland,

I guess that it comes down to semantics. the information that is being captured both in an NCMR or in my Excursion Report both include all the requisite information. I am not sure how you can be forced to pigeon hole it into a "non-conformance" because by that definition all unscheduled maintenance on any machine would an NCMR. Is a light bulb out on a non-validated piece of equipment cause for an NCMR?

You begin down a slippery slope and you can overtax the NCMR process. I prefer to seperate them and to write a procedure that limits the scope and breadth of the issues that necessitate an Excursion Report being inititated.

[gholland]

I understand the trepidation... approaching it this way could overtax the NCMR system which is why I was wondering if anyone else has heard this feedback.

The auditor was in total support of writing all unscheduled maintenance related to producing product for sale in the NCMR system as an unscheduled maintenance occurence indicates something in the process didn't meet the requirements of the process to produce good product therefore it's a non-conformance under the ISO definition of 'non conformance'.

In her view you could do quick dispositions of these but it would allow you to use the data generated for tracking the effectiveness of your CA/PA process assuming that if you have repeated issues with a certain machine process you would do a PA. She also stated that FDA looks at 'excursions' on validated processes as not meeting a requirement of the process. Like I said, this was a much different way of looking at things focusing much more on the compliance side than the business side of the business.

We also asked why we couldn't use our PM system to track these but her opinion was that we should be establishing root cause, tracking the frequency of the non-conformance, and dispositioning the product so why not use the system that is already set up for this (NCMR)?

The non-validated equipment wouldn't be NCMR'd as it isn't involved in producing parts for sale.. at least I hope not... but using a light on a validated piece of equipment... her example would be to write it up as an NCMR and your QA person would disposition it 'Use As Is' with the non-conformance having no effect on the product. Then if you had a large number of these non-conformances you might open a PA and maybe it leads to something else wrong with the system.

gh

[RCW]

In Reply to Parent Post by DrM2u

Stonehouse, you are correct. There is no requirement in ISO9001 or ISO 13485 to keep records of impact of equipment failure on product quality. Is it good practice to do so?!? Depends ... There are a few considerations:

.......

An auditor will/should not document any findings against an inexistent requirement, regardless where in the world they are. Hope these thoughts help some.

I'm digging out from a brutal ISO 13485 / 9001 surveillance audit and had the following finding against me which sounds similar to what is being discussed here:

"Preventive Maintenance Procedure, XXXXX Rev X, does not clearly address corrective/demand maintenance and the possible impact on product quality as the result of performing such maintenance."

I re-read Clause 6.3 and I'm at a lost as how to derive the statement above out that clause. As stated here it is a good idea and a good practice to do such but how can I be written up for not meeting a requirement when it isn't an actual written requirement?

[Ronen E]

In Reply to Parent Post by RCW

I'm digging out from a brutal ISO 13485 / 9001 surveillance audit and had the following finding against me which sounds similar to what is being discussed here:

"Preventive Maintenance Procedure, XXXXX Rev X, does not clearly address corrective/demand maintenance and the possible impact on product quality as the result of performing such maintenance."

I re-read Clause 6.3 and I'm at a lost as how to derive the statement above out that clause. As stated here it is a good idea and a good practice to do such but how can I be written up for not meeting a requirement when it isn't an actual written requirement?

Hi,

Assuming you were referring to 13485,

...documented requirements for maintenance activities... when such activities or lack thereof can affect product quality.

This relates to "maintenance", not only "planned maintenance" (do you have another procedure for corrective/demand maintenance?)

Cheers,
Ronen.

[Big-R]

I agree with Ronen E. It sounds like the auditor was looking for an SOP which explains how your factory deals with unscheduled maintenance activities and how those activities are assessed.

Ryan

[RCW]

Yeah, upon review, that is definitely missing. This got missed when I converted from ISO 9001 to the ISO 9001 / 13485 combo.