Problems with process equipment

#1
Hello everyone.

Some time ago external audit discovered problems with process equipment - no validation protocols, no supervision, and so on. Now I have to do the audit of this equipment and part of process acc. to ISO 9001, 13485, MDD 93/42/EEC. Could you give me some advice how to do it in a comprehensive manner?
I think I should check:
- if this part of process is included on the production process chart (ISO 9001, p. 4.4.1 b)
- if there are documented requirements for the maintanence activities, including the interval of performing the maintanance activities + records from that activity (ISO 13485, p. 6.3)
- if the work environment is documented and monitored acc. to adequate procedure + records from monitoring (ISO 13485, p. 6.4.1) + records from checking the measuring equipment - f.ex. termometer, hygrometer (ISO 3485, p. 7.6)
- if the personnel performing work is competent - records from trainings (ISO 13485, p. 6.2, 6.4.1; ) and have assigned responsibilites (ISO 9001, p. 4.4.1 e)
- records from validation of the equipment: IQ, OQ, PQ (ISO 13485, p. 7.5.6)
- instruction how to operate the equipment to produce the device in conformity to requirements (ISO 13485, p. 7.5.1a)
- if the traceability of product is maintained in this process (ISO 13485, p. 7.5.9)

What do you think?
 
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Tidge

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#2
Is this process equipment the direct responsibility of a medical device manufacturer, or is it in use at a supplier?

I feel as if there is a layer missing from the consideration. The standard authorities mentioned (13485, etc.) don't provide necessary details for specific processes, but instead establish the necessary requirements for entire (quality) systems. Presumably the root cause of the issue with 'no validation of equipment' was that there was no process for guaranteeing that a validation was done. The audit (e.g. against 13485) presumably reveals the defect to be that the (medical device manufacturer) has insufficient procedures for process validation internally or at suppliers (where necessary). If a procedure exists and is sufficient, you should be auditing (the process) against the established procedure. The established procedure (if sufficient) will cover the necessary areas of the relevant standards.

If the effort is to plan a remediation of a specific production process, the effort is to identify the necessary information that is missing as prescribed by the governing quality system process. If the governing quality system process is deficient, start with remediating that part of the QMS (if possible, if supply chain and lead times allow... presumably containment measure will have to be implemented) because otherwise you will end up looking at the specific manufacturing process multiple times. You will do it (at least) once in the ad hoc manner described, and then it will be revisited to assure compliance with the (revised) QMS.
 
#3
Is this process equipment the direct responsibility of a medical device manufacturer, or is it in use at a supplier?
the direct responsibility is manufacturer

Presumably the root cause of the issue with 'no validation of equipment' was that there was no process for guaranteeing that a validation was done. The audit (e.g. against 13485) presumably reveals the defect to be that the (medical device manufacturer) has insufficient procedures for process validation internally or at suppliers (where necessary). If a procedure exists and is sufficient, you should be auditing (the process) against the established procedure. The established procedure (if sufficient) will cover the necessary areas of the relevant standard.
You are right, there is no procedure. Sorry, there is a procedure which is written on the paper but this procedure is no implemented. I have some problems with the top management to accept, sign procedure and to use it (CEO is responsible for described area). So the problem is bigger, I know but I try little steps, and the situation like this, where external audit discovered the problem causes that I can say: "I said so" and "We need to get it done"...
 

Tidge

Quite Involved in Discussions
#4
Thanks for the clarification. This sounds like this is more like a CYA exercise where the 'audit' is intended to expose elements of 'little q' quality that may be lacking (in a specific process) as opposed to 'Big Q'. I've been in the next step of this specific situation (with regards to process validation) and I have found it very frustrating for a variety of reasons, the ultimate source of frustration is (eventually) going to be that no matter how complete and thorough the process validation ends up being, the lack of a master validation plan and a governing process will mean that the entire effort will be re-remediated ...and possibly "threemediated" when management injects an 'interim' gap assessment.

You sound like you are on the right path by listing the examples of things you would expect to find (e.g. IQ/OQ/PQ) but your roles as an auditor should be to identify elements (from the applicable authorities/standards) that are necessary first, and then list the examples of sorts of things that would be evidence that those elements are met. For example, within 13485:2016 the germ of the mandate for process validation in production is probably in 7.3.8 (Design Transfer) and 7.5.1 (Control of Production and Service Provision) but you can probably just jump to 7.5.6 (Validation of Processes for Production and Service Provision) with a healthy dose of 7.6 (Control of Monitoring an Measuring Equipment). Sections 7.3.8 and 7.5.1 are bigger cans of worms such as risk management and derivation of process parameters in the realization of design outputs that (I am guessing) this company isn't that good at either (or the production process in question would have been validated).

There is a "practical guide" published for 13486:2016 put together by TC 210, but the guidances for 7.5.6 aren't radically different than 'open source' information that could be found via IMDRF (see the older GHTF documents for Medical Device manufacture for instance).
 
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