Validation of existing equipment - I have been asked to write a quality assessment for equipment

duff999

Quite Involved in Discussions
Can I run a scenario by you as to my plan.
1. Create an overall master validation plan - then create my validation/qualification of equipment into a validation plan
2. Use a risk based approach to qualify the equipment that is already installed - does a high, medium, low risk level work?
3. List all equipment and assign the level to each
4. Since all the equipment is already installed I will IQ based on the equipment was installed per mfg spec, in the proper manner, and is placed in a suitable environment.
5. use the rationale that all end product produced is 100% QC per work instruction
6. Rationalize that the last 3 lots of the DHR were reviewed and no failures observed
7. write 1 final report stating the equipment was installed properly, and using 100% inspection, and the inspection of the last 3 lots showed no defects, and it is verified this way.

Anything else I should consider?
Thanks
 
My opinion, I would not write one report for all equipment. Qualifying equipment is not a one-time thing. Each equipment may have its own requirements for re-qualification. The activities you will do to qualify your equipment and validate your processes need to fit into your ongoing quality system processes.
 

yodon

Leader
Super Moderator
Completely agree with @indubioush. And process validation isn't necessarily a one-time thing, either.

One thing to be aware of is the 3-lot approach. Historically, that has been an acceptable approach but inspectors / auditors are starting to ask for the statistical rationale for the approach.
 
Maybe this also will help.
Your master validation plan could include: all manufacturing processes, statement of whether process output is verifiable, associated equipment, associated process parameters (e.g., time, temp, etc.), risk level, determination of whether IQ is required, OQ is required, and PQ is required.

Examples:
Cut tubing, 100% verifiable, ruler, 10 +/- inches, low risk, IQ not required, OQ, not required, PQ not required
Bond tubing to flush port, not verifiable, 6 drops loctite and heat cure at 50 C 30 seconds, med risk, IQ required, OQ required, PQ required

In the first example, simple calibrated equipment is used and the results of the process are able to be verified. In the second example, more complex equipment that requires electricity and settings is used. Also, the bond is not able the be verified. Therefore, IQ, OQ, and PQ are required.

So, what do you do for the IQ, OQ for equipment? Let's say you need to qualify your hot box that you use in the bonding process. IQ will include things like, is it plugged in to the correct energy source, does it turn on, does it provide the temperatures promised by the manufacturer. You will actually have to show that equipment was installed according to the manufacturer specifications. You can't make a blanket statement. The OQ will include things like is the bond adequate at 5 drops with 20 second heat cure.

Rather than trying to hurry up and show that all of your equipment is qualified, focus on your quality system and outline the ongoing process for equipment and process validation. In the meantime, write up a validation plan and determine what equipment needs IQ and do that first. Then continue onto OQ for each equipment and process. As long as you have a quality process and show that you are working toward qualification, you will be fine.
 
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