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Customer Audit Finding ISO13485:2016 7.6

Deli88

Starting to get Involved
#1
Hi Cove,

I'm struggling to close out an audit finding with a customer.

The finding was against Magnehelic gauges on a brand new cleanroom we completed recently. The gauges had not been properly calibrated or verified at the time of the audit Our procedure states that we must calibrate equipment before it is put into use, and we do normally with all our equipment.

The reason the gauges weren't calibrated or verified was because it was believed that the commissioning company had carried out verification during the validation of the cleanrooms, however, they had not verified the gauges only the room pressures.

The gauges have since been verified and are included in our schedule for calibration.

How do you root cause an accidental omission of a single piece of equipment?
 

JoshuaFroud

Involved In Discussions
#2
There are a couple of ways you could approach this;

Prior to use, was the installation report reviewed? If so this should have picked up the gauges had not been calibrated - There is a potential gap in your hand over procedure stating what must be verified prior to production use, or if it is in the procedure a training issue with the operator conducting the review.

You've stated that the gauges are not included on your calibration schedule, were they not before the lack of calibration was detected? If not, that is another gap as a new device requiring calibration was introduced to the manufacturing stream without being added to the appropriate schedules. It is probably covered in a procedure who is responsible for ensuring new equipment is added to the required registers, if so the root cause could lie here.

When I have worked with Gauges of this nature in the past they have had a calibration sticker on them, in our SOP is asked the operator to verify (and sign for) the gauge being within calibration before conducting manufacture - if this check was in place the error would have been detected prior to the first production run starting. Again, this is either a procedural or training weakness.

If you want to take it back even further, does the contract with the installer of the clean room state they should have calibrated the gauges and provided evidence as such prior to job completion. If not, adding this requirement into further contracts (in addition to production hand over verification) would help to prevent re-occurrence.

Depending on your internal procedures, there are multiple points at which this could have been detected prior to material being produced in an environment controlled by an uncalibrated gauge. I would pick one (or more) of these are the root cause and work to address them.
 

Al Rosen

Staff member
Super Moderator
#3
Hi Cove,

I'm struggling to close out an audit finding with a customer.

The finding was against Magnehelic gauges on a brand new cleanroom we completed recently. The gauges had not been properly calibrated or verified at the time of the audit Our procedure states that we must calibrate equipment before it is put into use, and we do normally with all our equipment.

The reason the gauges weren't calibrated or verified was because it was believed that the commissioning company had carried out verification during the validation of the cleanrooms, however, they had not verified the gauges only the room pressures.

The gauges have since been verified and are included in our schedule for calibration.

How do you root cause an accidental omission of a single piece of equipment?
The Root Cause was the procurement process and the failure to perform Installation Qualification.
 
#4
The problem being your not in the business of procuring cleanrooms. How many more are you going to do? Like others have said, there is a miss in your procurement/handoff/verification processes. To me, this is a correction -- you got the gages verified. Full root cause/corrective action probably won't get you anywhere. You'll need to tap dance around it to get your CA "approved." Good luck.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
I mostly agree with @Golfman25. Not every glitch requires a CA. Here it's more of a customer-relations issue - soft-manage to maintain customer satisfaction (real Quality) and, as already done, ensure correction.

Before a root cause is sought, a clear definition of the problen/failure is necessary. If it's the cleanroom gauges not being calibrated, see Golfman's post. However, this can be generalised and then the root cause determination may be different. But I would first ask: Is this a real recurring / major issue? Has anything similar occured with other manufacturing equipment? How may times? How often?

Being efficient is not about dealing with everything. It's about identifying what matters and focusing resources allocation there.
 

Tagin

Involved In Discussions
#6
Hi Cove,

I'm struggling to close out an audit finding with a customer.

The finding was against Magnehelic gauges on a brand new cleanroom we completed recently. The gauges had not been properly calibrated or verified at the time of the audit Our procedure states that we must calibrate equipment before it is put into use, and we do normally with all our equipment.

The reason the gauges weren't calibrated or verified was because it was believed that the commissioning company had carried out verification during the validation of the cleanrooms, however, they had not verified the gauges only the room pressures.

The gauges have since been verified and are included in our schedule for calibration.

How do you root cause an accidental omission of a single piece of equipment?
1) It is unclear from this text whether the lack of verification violated your procedure: were the gauges put into use before verification or not? If they were put into use before verification, then there is an issue with following procedure.

2) Even if it was expected that the commissioning company had carried out verification on your behalf, that verification result should have been recorded in your calibration records. This would indicate a calibration record-keeping failure.

It might be that a simple installation checklist could have prevented this, and that the corrective action is to implement such checklists for any future installations of equipment/facilities.

If a checklist was used, but this gauge verification was not on it, then maybe it indicates the need to have a predefined template for such checklists, which includes all important areas (such as calibration), as a way to provoke thinking about such things that can occur with an installation and so making sure they happen.
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#8
Assuming you added this supplier to your approved supplier list you could add a check item on the supplier review that references "Are calibrated items a consideration for this purchase?"
 
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