ISO 13485 and IQ (Installation Qualification), OQ (Operational Qualification)

Bill Evans

Involved In Discussions
#21
On June 5th we are taking delivery of a Robotic Welder that TIG welds square tubing 11-18 ga. with welds no more than 3 inches in length. It has an indexing table with one arm. There are (2) two stations, A & B on the table.
We have PQR's and WPS's for that we currently use for existing equipment. We use control plans that define characteristics and frequencies of inspection.
We do not have a procedure that defines IQ,OQ, and PQ under the FDA guideline.
What I am was hoping to find was an example SOP with forms that I could use as a foundation to modify content.

Thanks

Bill
 
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Bill Evans

Involved In Discussions
#24
I am fairly certain I have this correct.

In ISO 13485 7.5.2.1 and /or CFR 820.75


The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

So if I am able to detect process change via. measuring the output of a process (ie. stamping press output = a part..thereby the dimensional inspection is the subsequent measuring and monitoring) or (molding process output = part..thereby the dimensional inspection is the subsequent measuring and monitoring),

Then according to the standard or regulation these process are exempt from Validation requirements.

Thoughts?
 

Ronen E

Problem Solver
Staff member
Moderator
#25
I am fairly certain I have this correct.

In ISO 13485 7.5.2.1 and /or CFR 820.75


The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

So if I am able to detect process change via. measuring the output of a process (ie. stamping press output = a part..thereby the dimensional inspection is the subsequent measuring and monitoring) or (molding process output = part..thereby the dimensional inspection is the subsequent measuring and monitoring),

Then according to the standard or regulation these process are exempt from Validation requirements.

Thoughts?

Almost. Ability is necessary but not sufficient. 100% verification (e.g. measurement) is required to actually take place, to relieve any process validation duties.

Cheers,
Ronen.
 

Bill Evans

Involved In Discussions
#26
We perform process capability studies with Cpk indices that determine sample size and inspection frequency. We do not have to perform 100% inspection based upon a stable and capable process.

As with most production processes, when an issue is identified , product segregation occurs, and the process is brought back into a state of control and a frequency based inspection ensues.

Again, supporting the rationale dimensional inspection is the subsequent measuring and monitoring
 

Ronen E

Problem Solver
Staff member
Moderator
#27
From a regulatory perspective, critical outputs are required to be 100% verified unless the process is validated. In some cases, less than 100% is acceptable, but the statistical rigor and confidence have to be high, for this to fly.

If your process capability studies were part of a formal Process Validation, that's acceptable. Otherwise, I'm not aware of a regulation stating that certain Cpk values exempt from the above. If you are relying on a guidance document, I'd appreciate a pointer.

Thanks,
Ronen.
 
#28
Do any of you have an example or template of a Regulatory or Quality Plan for moving medical device manufacturing from one facility to another?

Having trouble getting started. Thanks!
 

Bill Evans

Involved In Discussions
#29
Ronne

In reviewing ISO 13485 or even the 21 CFR 820 it again stats " where the resulting output cannot be verified".

Dependent upon the process (ie. machining, forming, grinding, laser cutting) all of these may be verified by subsequent monitoring OR measurement.

Processes that can not be verified ( Examples include welding, soldering, brazing, molding, painting and laminating. The resulting output cannot be partially or fully verified by a subsequent monitoring and measurement step.

Deficiencies (for example, cracks, peeling and corrosion) show up as defects after the product is in use.

So any process " where the resulting output can be verified" does not require validation. Proper use of statistical tools and analysis of data (13485; 8.4) will provide a rationale for using Cp, Cpk, Pp, Ppk indices.
 

Ronen E

Problem Solver
Staff member
Moderator
#30
Ronne

In reviewing ISO 13485 or even the 21 CFR 820 it again stats " where the resulting output cannot be verified".

Dependent upon the process (ie. machining, forming, grinding, laser cutting) all of these may be verified by subsequent monitoring OR measurement.

Processes that can not be verified ( Examples include welding, soldering, brazing, molding, painting and laminating. The resulting output cannot be partially or fully verified by a subsequent monitoring and measurement step.

Deficiencies (for example, cracks, peeling and corrosion) show up as defects after the product is in use.

So any process " where the resulting output can be verified" does not require validation. Proper use of statistical tools and analysis of data (13485; 8.4) will provide a rationale for using Cp, Cpk, Pp, Ppk indices.
So theoretically even 0% verification would suffice because the resulting output can be verified?... :)

Good luck taking that approach to the FDA. I'd love to hear back after they endorse it, and expand my knowledge base.

Please also note that I didn't say it's impossible:

In some cases, less than 100% is acceptable, but the statistical rigor and confidence have to be high, for this to fly.
The thing is that it's more the exception than the rule.

Cheers,
Ronen.
 
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