Out of specification procedure for Medical device manufacturing

[Disadolly]

HI
I was tasked to implement an Out of specification procedure for medical device manufacturing based on the FDA Guidance For Industry Investigating Out-of-specification (OOS) test results for Pharmaceutical Production October 2006. Has anyone implemented something similar and have you perhaps found a more suitable guideline to use?

 

[yodon]

I'm a bit lost. Are you a device manufacturer or a pharmaceutical manufacturer? What, specifically, was the test that failed?

 

[Zero_yield]

https://www.fda.gov/media/71001/download

I think this might be the guidance document Disadolly is referencing.

The big two medical device QMS regulations are 21CFR Part 820 for the FDA and ISO 13485.

Are you trying to implement a new procedure for OOS incidents?

 

[blackholequasar]

What do you currently have in place for containment regarding this kind of thing? I would assume that looking at the risk of occurrence, there may be a process that you have started that could be extrapolated on?

 

[Disadolly]

Yes, we are a medical device manufacturer. We apply a sampling procedure to final batches for QC routine destructive testing. In the past we would have rejected a batch if one of the samples failed, but now we need to implement a OOS procedure where we need to investigate the cause, test more samples, and if the additional samples pass, pass the batch. I understand the pharmaceutical guideline given to me to implement, to be based on resampling from a larger volume sample to test and is a check to see if the lab testing procedure was correct. Implementing this pharmaceutical guideline for single unit medical devices does not make sense to me

 

[Disadolly]

I think this might be the guidance document Disadolly is referencing.

The big two medical device QMS regulations are 21CFR Part 820 for the FDA and ISO 13485.

Are you trying to implement a new procedure for OOS incidents?

Hi, your reference is spot-on. We are CE certified and have FDA approval for the devices. This is a new procedure for OOS that I need to implement, as we do not have such a procedure. In the past, if the sample devices failed at final QC testing, the entire batch was rejected.

 

[Disadolly]

I'm a bit lost. Are you a device manufacturer or a pharmaceutical manufacturer? What, specifically, was the test that failed?

We are a medical device manufacturer. The tests referred to are the final QC routine mechanical destructive testing of the device performed on a sampling plan of the batch.

 

[Zero_yield]

I'm in med device manufacturing. I'll try to explain what I know about sampling, but statics are not my specialty

For each type of in-process sampling we do, we have a documented sampling plan based on ISO 2859-1. Sampling is based on severity of the issue being checked (i.e. patient risk), detectability, and the level of validation of the relevant product / processes. For some (not all) processes where we sample, we have a documented second/double sample plan.

So for example, we have a process where we sample a dozen or so parts out of a batch of >1000 parts. This is based on ISO 2859-1, Level 2-4, AQL=1.0, single sampling. There's some variability in the process - the beginning of the batch could be slightly different from the end of the batch, and there's different positions that each see slightly different processing. The sampling specifies picking samples from the beginning and end of the batch, as well as each of the different positions to make sure the samples are representative of the batch.

When we have a failure, it usually applies to the entire batch (it's not that much variation), so we do often reject the batch even after investigation. Sometimes, the failure applies to one specific location within the batch. So let's say there was an issue at the beginning of the run - we could determine where the issue was resolved, reject all product to that point, and retest to confirm our correction was accurate.

The real value doesn't come from saving a batch here or a part of a batch there, though. It's doing the investigations, finding the root causes, coming up with appropriate corrective and preventative actions, and incrementally improving the process. I've seen plenty of issues that had a risk of a patient receiving a substandard product or were costing us big money every year go away completely because of good deviation management and good CAPAs.