How to do Equipment Validation - Establishing our ISO 13485 QMS procedures

[Aristo]

This is my first post, wish somebody can give me some ideas on this:
we are establishing our 13485 QMS procedures, is it necessary to indicate the validation of equipments(such as injection machine) in the procedure which is suggested by our consultant, but actually we do not and don't know how to do the validation for the equipment.
many thanks

 

[Ajit Basrur]

Re: equipment validation

This is my first post, wish somebody can give me some ideas on this:
we are establishing our 13485 QMS procedures, is it necessary to indicate the validation of equipments(such as injection machine) in the procedure which is suggested by our consultant, but actually we do not and don't know how to do the validation for the equipment.
many thanks

Welcome to the Cove.

I suggest that you include a procedure on Equipment Qualification as Level 2 document and could have a template for doing equipment qualification as Level 3.

I recommend to do equipment qualification for all major equipment like injection molding machine, material dryer, robots, mold temp controller etc.

 

[Gert Sorensen]

Re: equipment validation

This is my first post, wish somebody can give me some ideas on this:
we are establishing our 13485 QMS procedures, is it necessary to indicate the validation of equipments(such as injection machine) in the procedure which is suggested by our consultant, but actually we do not and don't know how to do the validation for the equipment.many thanks

A good starting point would be to read (and understand) the FDA guideline on process validation

http: // www .fda.gov/Cder/guidance/pv.htm - DEAD LINK FROM 2007

and also get a good grip of GAMP IV.

Second, you need to qualify personel to perform process validation. This includes management (IMO), otherwise you will never perform a single useful validation.

Third, you need to generate a Master Validation Plan, to prioritize your validation effort. This validation plan should take the guideline on whether or not to validate into consideration. Basically the guideline states that if you can securely verify the result of your process then you do not need to validate, but if you cannot, or have other reasons, e.g. financial, then you should. Since the task of validation is a burdensome one, and the amount of validation that may need to be done if your company is new to the requirements in 13485 is staggering, then I strongly suggest that you consider which of the validations will provide the most value to your company, and which are the easiest ones to perform so you start with some successes.

 

[Alex Kobzar]

Re: equipment validation

... validation of equipments(such as injection machine) ... we do not and don't know how to do the validation for the equipment.

Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.

Validation is only required where "routine end-product testing" is not sufficient to assure "product quality".

I would strongly recommend to avoid "straight-forward" approach like "here is the mold machine producing MD's; let's go to validate it".
In my experience (with production of rubber catheters) a mold machine shall rarely be a subject of a validation because the features of a molded product may mostly be inspected with an acceptably-high degree of confidence.

Then, for example, if a Product FMEA says that all deviations from the requirements of the "pre-determined specifications and quality characteristics" are having low RPN's (usually due to, e.g. the features being 100% automatically tested; when such testing is likely to be established for critical/safety features of an MD) then the subject of a validation shall be the test equipment and probably not the mold machine.

 

[Gert Sorensen]

Re: equipment validation

Validation is only required where "routine end-product testing" is not sufficient to assure "product quality".


I would strongly recommend to avoid "straight-forward" approach like "here is the mold machine producing MD's; let's go to validate it".
In my experience (with production of rubber catheters) a mold machine shall rarely be a subject of a validation because the features of a molded product may mostly be inspected with an acceptably-high degree of confidence.
Then, for example, if a Product FMEA says that all deviations from the requirements of the "pre-determined specifications and quality characteristics" are having low RPN's (usually due to, e.g. the features being 100% automatically tested; when such testing is likely to be established for critical/safety features of an MD) then the subject of a validation shall be the test equipment and probably not the mold machine.

In my experience, in medical devices, the absolute sinner in a company is the plastics department. The components they produce are usually very cheap, and the attitude behind the production reflects the price. Unfortunately the quality that is the result of this attitude is a varying, to put it mildly, resulting in an output that creates trouble for the rest of the company, since these parts is critical for the products and the processes.

If I were to put a financial view on my validation efforts, then I would always prioritize validation of plastics before any thing else (excluding sterilization of course )

 

[gszekely]

Check out this attachment
DEAD LINK REMOVED
posted in this thread by Qualityalways
Validation of Processes - Plastic Injection Moulding - ISO 9001 Clause 7.5.2
and other threads on the subject, for example the results of a search for GHTF (Global harmonization Task force):
GHTF is no longer in operation
Good luck
György

 

[maxwell]

Aristo
Attached you will find a IQ/OQ (Installation Qualification/Operational Qualification) validation protocal. This plan is based on plastic injection molding machines, You will need to tweak for use on your machines. Use the operations manual received with your machine to tweak validation procedure. As previously stated as long as you can measure the results of the device manufactured you will not have to do process qualification.

 

[Aristo]

it's very helpful!!

 

[Gert Sorensen]

Aristo
Attached you will find a IQ/OQ (Installation Qualification/Operational Qualification) validation protocal. This plan is based on plastic injection molding machines, You will need to tweak for use on your machines. Use the operations manual received with your machine to tweak validation procedure. As previously stated as long as you can measure the results of the device manufactured you will not have to do process qualification.

Seems like a good starting point, but I fail to see things like qualification of materials, qualification of surroundings, air, humidity, training of personell, cooling water, worst case scenario and establishing of process control...

I strongly oppose to not performing PQ on an injection moulding machine, just as I strongly oppose to not defining the worst case scenario or identifying the properties of the material needed for the process. It will greatly diminish the effect of the validation to the point of rendering it useless.

 

[RCW]

we are establishing our 13485 QMS procedures, is it necessary to indicate the validation of equipments(such as injection machine) in the procedure which is suggested by our consultant, but actually we do not and don't know how to do the validation for the equipment.

My questions/confusions start off similar to Aristo's but veer off in another direction. I am updating from ISO9001:2000 to ISO 13485. As long as my company has held an ISO9001 cert, we have always claimed an exemption to 7.5.2 Validation. The reason behind the exemption is that we feel we can verify our product through inspection and test.

A few years ago, one of our customers was in here performing an audit for production of medical devices. They jumped all over me for not having installation qualifications in place for our surface mount line which includes a solder paste stencil machine, pick&place machine, and solder oven. I told them we verified product through inspection and test but they would have nothing of it. I asked several times to show me their requirement but they could produce nothing. Management wanted to pacify the customer so installation validations were done along with validation of software. (The software validated was written internally to control purchasing parts and inventory control. IMHO this didn't need to be done either.)

We recently bought replacement surface mount equipment and validations were performed again. I asked the operator why he was performing the validation. He said he didn't know why. Only that it was done before.

Continuing on...
ISO 13485 calls out for the validation of computer software used for the production/service process. We use software with a continuity test box (used to check wiring on medical devices) so I am assuming that requires validation. From my previous example, I am assuming an inventory control program does not require validation.

So where am I going with this?
1) If I can truly verify product through inspection and test, do I need to perform installation qualification / validation?
2) I can no longer claim exemption to 7.5.2 under ISO 13485 because I have to validate the test box software?
3) Were the requirements placed upon my company by the customer right or wrong?

As I am suppose to be the expert on all this quality stuff, talking to others here has led me to even greater confusion. (One person told me, you're the expert, go look in the mirror and ask the question.)