Validation of Special Processes - N/A of ISO 13485 Clause 7.5.2

#1
Hello friends,

I've had a Major non conformity in last audit by Notified Body regarding the non application of 7.5.2 clause that says that "organization must validate those production processes where the resulting products can't be verified"

OK, we manufacture medical devices assembling different parts from different suppliers. Every finished device is tested before sending it to customer.

But auditor said: You must applicate this clause because there are special processes.
One of or supplier is a electrical wiring supplier and we assembly them into the device. They say that there's not special process validation like the crimping of purchased wiring.

If we make a verification of the resulting product, why do we have to apply this clause in this case?
Do you think we have to appeal this non conformity?

Any comment is welcome
Regards,
 
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G

Gert Sorensen

#2
Re: N/A of 7.5.2 clause

How do you attach the wires and to what? Tell us a bit more about the process, please.
 
S

SteveK

#3
Re: N/A of 7.5.2 clause

We produce class IIa/IIb devices via a fairly simple hand assembly process. As such we have excluded 7.5.2 - and this is indicated in the Quality Manual which states:

This section requires the organization to validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
Acme’s products involve basic hand assembly operations; all the resulting assemblies and sub-assemblies are monitored or measured throughout the process. Operators test products 100% at the assembly stage. They are further sampled and tested at the quality inspection stage. As such the resulting output can be verified with respect to the requirements of this section of BS EN ISO 9001:2008 and BS EN ISO 13485:2003, as such there are no processes to validate (see clause 1.2 in both BS EN ISO 9001:2008 and BS EN ISO 13485:2003 relating to exclusions in clause 7).

This was not questioned during my last 2 audits - the last one being a level 3.

I think you should challenge the NB on this matter IMO.

Steve
 
#4
Re: N/A of 7.5.2 clause

Some of the wires are screwed into other parts(clocks), some of the are simply attached (crimped wires attached to parts with faston connection, or to a PCB with quick connector) and a few ot them are welded to eg. main supply connector or fuses.

In the final verification we make also "electric circuit verification"

Thanks
 
G

Gert Sorensen

#5
I believe that your NB could have a point here. You have a variety of wire-application methods and one of them is considered a special process. If I were you I would not challenge the observation, I would validate my welding process, and try to close the observation by doing so.
:bigwave:
 

somashekar

Staff member
Super Moderator
#6
Hello friends,

I've had a Major non conformity in last audit by Notified Body regarding the non application of 7.5.2 clause that says that "organization must validate those production processes where the resulting products can't be verified"

OK, we manufacture medical devices assembling different parts from different suppliers. Every finished device is tested before sending it to customer.

But auditor said: You must applicate this clause because there are special processes.
One of or supplier is a electrical wiring supplier and we assembly them into the device. They say that there's not special process validation like the crimping of purchased wiring.

If we make a verification of the resulting product, why do we have to apply this clause in this case?
Do you think we have to appeal this non conformity?

Any comment is welcome
Regards,
Hello sir, go soft on your appeal things please.
Validation is a requirement, this you will agree, and as long as you have studied all your processes and decided that there are no processes requiring validation with apt rationale you are ok. However please note that validation also goes beyond your controlled processes to out sourced processes and here you have to establish necessary controls including proper validation either by you or by your outsourced vendor.
In your case crimping is a process which requires validation. So you have to map this in your validation plan. Since you are outsourcing this, you have to show evidence of control exercised and establish how validation is being done on this process at your outsourced vendor.
Any soldering done inhouse or at outsourced vendor... ? this also needs a validation and must be in your validation plan.
Please relook at all your processes and make a plan where validation applies.
 
M

MIREGMGR

#7
There is extensive history of crimping as a wire-to-termination process being functional during final verification because physical point contact exists, even though the crimp was not performed or was performed incorrectly. Then at a later time, the point contact oxidizes, is contaminated or is mechanically displaced.

Among other things, validation of a crimp termination process might include establishment of a means for proving that each crimp was done within specs, combined with analysis to show that every crimp done within specs will be functional and reliable.
 
#8
Thanks to all.
By the way, wich could be an acceptable validation for a wire-to-connector soldering?
Would be enough with the qualification of the operator and a continuity test?

Thanks
 
M

MIREGMGR

#9
Would "qualification" of the operator be to a standard that defines classes of workmanship reliability and self-inspection, i.e. USA mil-specs, ANSI/IPC, or some other formal standard system?

As to continuity testing...I don't think one-time continuity testing is ever sufficient to verify a connection's quality, unless the process is physically impossible without establishing an electrically reliable mechanical connection and the test also verifies that the mechanical connection does exist. Simple continuity testing does not reliably detect cold joints and incipient failures that later will manifest due to vibration or pull.
 
M

mogluk

#10
I like validation but I feel in this regard I am going to have to come down on the side of the company I think that there is some merit to to debate this finding, if nothing else to bring down to a minor.

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement.

Now it seems that the process your referring to is a crimping of wire. My first question is why is the auditor looking at this? is this an output of your field surveilance (service records or complaint system) if so then I would look at an engineering change to alter the defect as much as possible. If not that would be the first place I would point to for justification of no validation. I would point out that the strength of the crimp is tested by the assembler and the functionality of the device is tested prior to release, combine those with no resultant field reports of failure and I would definitely argue that finding.

I would say through my experience that major findings should be applied in the event of systemic issues or willful nonconformation to the standard....or perhaps gross resources gaps (knowledge and personnel).​
 
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