Procedure for Validating Laser Marking & Electropolishing of Orthopedic Implants
- Thread starter mpfizer
- Start date
J
jscholen
This is a copy , paste and edit from a similar post I made:
This is based on an IQ/OQ/PQ validation methodology.
IQ: Ensure you have installed the equipment to the manufacturers specification by documenting the installation and verification of the equipment. If the manufacturer installed it for you, their is probably a installation sign-off from them which would suffice for this, just included it in your validation documentation.
OQ: The primary focus in an OQ is testing the limits of your manufacturing process. In the case of the Laser marking or ElectroPolishing, you want to establish the range of variable parameters that can be set on the machine, ie, feeds, speeds, Voltage rates, etc. You will want to establish which combination of variable parameter work well together and what the range is for each parameter to produce product to specification. Your in essence trying to find the right and wrong combination of parameters to ensure you are always confident you will produce good results. Once you establish a range of values that produce good results, then you will execute a PQ.
In PQ, you want to establish that your process can maintain the middle of the range of each combination of parameter you tested over the long haul...current Good Manufacturing Processes dictate 3 separate manufacturing orders....This is where you want to ensure that you can maintain good results and good product between separate operations, ie, shift changes, weekend shutdowns, Operators, etc.
Primary focus of a Validation is ensure that there is a plan, procedures are in place for the equipment, and people are trained AND everyone involved in the validation is aware and trained in the validation plan. Keep training records.
Also, have a provision for deviations in your initial validation plan, because stuff always happens that you didn't expect, so you want to be sure you provide for a way to address deviations...but you address them in a logical manner and the corrective actions makes sense or you will need to do it all over again.
Hope this helps, and I'm sure I have missed some aspect of validation because there is also the factor of risk management and how to ensure you are addressing potential risk in manufacturing that could affect the device at the point of use(human body)...this is best done with risk analysis tools such as FTA and FMEA.
Jeff
This is based on an IQ/OQ/PQ validation methodology.
IQ: Ensure you have installed the equipment to the manufacturers specification by documenting the installation and verification of the equipment. If the manufacturer installed it for you, their is probably a installation sign-off from them which would suffice for this, just included it in your validation documentation.
OQ: The primary focus in an OQ is testing the limits of your manufacturing process. In the case of the Laser marking or ElectroPolishing, you want to establish the range of variable parameters that can be set on the machine, ie, feeds, speeds, Voltage rates, etc. You will want to establish which combination of variable parameter work well together and what the range is for each parameter to produce product to specification. Your in essence trying to find the right and wrong combination of parameters to ensure you are always confident you will produce good results. Once you establish a range of values that produce good results, then you will execute a PQ.
In PQ, you want to establish that your process can maintain the middle of the range of each combination of parameter you tested over the long haul...current Good Manufacturing Processes dictate 3 separate manufacturing orders....This is where you want to ensure that you can maintain good results and good product between separate operations, ie, shift changes, weekend shutdowns, Operators, etc.
Primary focus of a Validation is ensure that there is a plan, procedures are in place for the equipment, and people are trained AND everyone involved in the validation is aware and trained in the validation plan. Keep training records.
Also, have a provision for deviations in your initial validation plan, because stuff always happens that you didn't expect, so you want to be sure you provide for a way to address deviations...but you address them in a logical manner and the corrective actions makes sense or you will need to do it all over again.
Hope this helps, and I'm sure I have missed some aspect of validation because there is also the factor of risk management and how to ensure you are addressing potential risk in manufacturing that could affect the device at the point of use(human body)...this is best done with risk analysis tools such as FTA and FMEA.
Jeff
J
jkonholm
Any example doc.?
J
jscholen
Global Harmonization Task Force has a sample Validation in the appendix of their guideline: Look for "Quality Management Systems-Process Validation Guidance" on their website.
R
RaymondB
Looking for a copy of a Procedure for Validation of Laser Marking and required protocols.
Does anyone have a copy with Protocols they could share?
Wanted to check in and find out if there was one that could be shared?
Does anyone have a copy with Protocols they could share?
Wanted to check in and find out if there was one that could be shared?
B
barkranch
It strikes me as very odd that every Google search I have done for validating machines or processes does not produce any good examples. Sure, the GHTF document has one or two validation examples but you would think there would be more machine or process specific examples to learn from? I guess people do not want to share their business specific protocols but they can cut out the specifics and replace the text with more generic statements. At least the generic documents would provide some insight or examples of what they should contain. Why re-invent the wheel, right?
C
cosmobenz
Any luck on this? I need the same thing.
B
barkranch
No one has offered an example yet. I am working on developing a template. When I finish it, I will post it in the thread.
C
cosmobenz
Great, please pass it on. Anything else you need? I may be able to help.
And why exactly would they want to invest work in that? For all they know they might be helping their competitors.
It's called proprietary information and most employees would be breaching their employment contracts if they shared such information without getting the employer's consent.
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