First problem with an Auditor in over 20 years - Validation of 'passivation' process

hi everyone,
first of all, i know i do not post enough on here but everyones input is always valued and researched often, and i direct many people to this site. i have developed and implemented many systems over the years and have never had a problem. my problem now revolves around "process validation". it is a special process, "passivate". the company having the problem is certified to 9001:2008 but was audited the first time to ISO 13485 by their customer and got hit on process validation. the company happens to also be a vendor of mine so i went down to help them out and i put in place some simple tools to help in the validation of their processes. i used simple tools such as flow charts, capturing data throughout the processes, (temps, concentrations, times, etc,) using the basic thinking that if you monitor and maintain the same indicators each time you will achieve the same desired results everytime. of course i understand the rule that through data analysis, you have to "prove" that the data you are tracking is valid and pertinent and contributes to the final results but the only way to do this is by gathering the data and the final results (statistical analysis) and thus validating the process. this takes time and data needs collected to make sure you are collecting the proper data to achieve those results.

the auditor came in today again and disputed the data we are collecting and called our process "elementary". yes, it is elementary, meaning that it is the beginning of a longer and more detailed process. but, i do believe and i have proven over the years it to be an effective method of process validation. i have rambled on forever now being i am very frustrated, but i guess my question would be, do you view process validation the same as me, do you view it as a system in which it is up to you to create, so that you can achieve the same DESIRED results at the end everytime? to me that is the goal, if the product comes out the same by following the same procedure and achieving the same indicators everytime then you have met your goal. i have used this method to meet ISO 9001, ISO 13485 CFR820, GHTF, and others through the years but now all of a sudden, this young buck is telling me i am all wet, and that validation falls under the same requirements of sterilization. i am stunned. thanks in advance and sorry for the rambling, this is why i don't post much.

Re: first problem with an auditOR in over 20 years

The auditor is just there to verify conformance, effectiveness and improvement.

You do what you need to do in the way that is most effective for you while meeting whatever requirements or needs present themselves and at no time are requirements or needs tobe generated by the auditor.



Austin, Texas? Wahoo!

I'm a South Austin boy having attended Travis and Crockett. We just did our 40th reunion in October.

Re: First problem with an Auditor in over 20 years - validation of 'passivation' proc

Hey bgtom!

Well... it depends. There are some processes that passivation is more critical than others. Also, there may be more variables than others. Maybe your level of testing did not appear to provide the confidence needed, given the process risk level. Not sure, though.

Was there a testing plan that was signed off my upper management?

As far as validation, I guess the end goal is to assure you are meeting the passivation requirements for the process. If you are using accepted measures of adequate passivation (rinse samples; ra finish; whatever it is), I'm not sure I see where there is an issue.

Simply, I would ask the auditor for clarification.

Re: First problem with an Auditor in over 20 years - validation of 'passivation' proc

Do I understand the CUSTOMER sent an employee to audit its supplier [which happens to also be one of your suppliers] to a Standard (ISO13485 - medical devices) for which it is NOT currently registered?

The plain fact is it is most likely auditing the supplier to its own requirement. As I recall ISO 13485, there is no absolute criterion for validating passivation or sterilization within the Standard.

As a simple compromise, the point is NOT to satisfy an undocumented whim of an auditor, but to approach the top dogs at the customer for a specific written requirement for the passivation process and subsequent validation of that process and then to adhere to it.

On countless occasions, we counsel folks with disputes with an auditor to DEMAND, "Show me the shall!" My guess is there is no written "shall" and the auditor is acting beyond the scope of his authority. However, nothing is served by arguing with the auditor; the topic needs to be discussed at a level far beyond his pay grade.

Re: First problem with an Auditor in over 20 years - validation of 'passivation' proc

Wes Bucey said:

As I recall ISO 13485, there is no absolute criterion for validating passivation or sterilization within the Standard.

Click to expand...

Hi Wes - Merry Christmas.

Under 7.1, Planning for product realization, ISO 13485 requires an organization to determine the required validations specific to the product. In the case of medical devices, I believe sterilization requirements would need to be assessed.

Re: First problem with an Auditor in over 20 years - validation of 'passivation' proc

Hi bgtom. I read your post a couple of times to be sure, and I don't see anywhere in your text that shows you did anything to validate that your process achieved the desired results to begin with.

You said:

bgtom said:

i used simple tools such as flow charts, capturing data throughout the processes, (temps, concentrations, times, etc,) using the basic thinking that if you monitor and maintain the same indicators each time you will achieve the same desired results everytime.

Click to expand...

After you've proved that the process achieves the required results, then monitoring and maintaining the process characteristics is an acceptable way to show that the process will consistently deliver those same results. Can you please clarify what you did to show that the process you use achieves the desired result?

Re: First problem with an Auditor in over 20 years - Validation of 'passivation' proc

bgtom,
Here is a link to the FDA web site for process validation.

http //www. fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122439.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

I hope this helps.

Phil

Re: First problem with an Auditor in over 20 years - Validation of 'passivation' proc

I'm not sure that pasivation is a special process. From what I understand it is essentially a cleaning process. What is there about pasivation that cannot be verified?

If it is a special process, then I agree with Howste that you have not established that the process controls you are monitoring will establish validation.

Are you following a published specification (aka "recipe")? If you are, that is the basis for showing that the end results will be satisfactory. If you are, then that specification becomes the basis for what you need to include in your process controls and should help you understand what needs to be recorded.

I have a feeling that your auditor has something in mind. It may or may not fit your application. You should ask him what he has in mind.

Re: First problem with an Auditor in over 20 years - validation of 'passivation' proc

Doug Tropf said:

Hi Wes - Merry Christmas.

Under 7.1, Planning for product realization, ISO 13485 requires an organization to determine the required validations specific to the product. In the case of medical devices, I believe sterilization requirements would need to be assessed.

Click to expand...

Yes! The process is up to the organization - not spelled out in ISO 13485 as an absolute criterion or formula for every registered organization tofollow.

The idea of jointly agreeing on the FDA validation process would be a good addition to the contract between customer and supplier, but in its absence, definitely beyond the scope of an auditor to make up rules as he goes.

Re: First problem with an Auditor in over 20 years - validation of 'passivation' proc

Indeed it is a process that requires to be validated and your view points are logical. I would look to see the standard to which your passivation is to meet and for your conclusion and fixing of the various processing parameters, what evidence of tests on this passivation per your standard is made ..?
There are laboratories which can conduct test on the specimen after passivation and provide results and based on this the validation outputs can be documented as the SOP for the passivation. A periodic test on random samples can be made as a part of the SOP to demonstrate continued suitability of the process and can also be termed as periodic re-validation.