90 Day Limit Imposed by NB to complete NCs raised at audit

#1
An EU auditor has given my client 90 days to complete NCs raised at audit.

Does anyone know where the NB got their 90 day rule from?

I am guessing it's one of their internal procedures?
Although I can't see how it can be possible to apply.

For example if a manufacturer needed a new injection moulding machine it's likely to take a lot longer than 90 days. In this example the manufacturer will have to close the business as the NB is threatening to withdraw certification if the machine hasn't arrived and actions aren't completed in 90 days!
 

Jean_B

Involved In Discussions
#2
If I recall correctly it is their internal policy based on non- binding external guidance and agreed upon with you in contract/report.
Waivers may be issued under exceptional conditions if you can make the case.
You only state a solution and not the NC so there's not really much more that can be said.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Jean_B is correct. If you need more time due to infrastructure, discuss with your Lead Auditor; the registrar's procedures may allow for closure based on actions taken (correction) and further actions planned (corrective action).
 
#4
You didn't say is it a minor or a major NC? A major indeed needs to be (partly) resolved in 90 days, while for a minor you have 1 year.
The purpose of those 90 days is to come up with a solution and execute it if that's feasible. If not, partial correction and having a plan in place should be enough to reduce it to a minor NC.

In your example of the injection moulding machine, having a proof that the machine was purchased/ordered together with all the validation (IQ/OQ/PQ) protocols and calibration schedule, would suffice in reducing the finding from a major to a minor.
 

Sidney Vianna

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Staff member
Admin
#5
In your example of the injection moulding machine, having a proof that the machine was purchased/ordered together with all the validation (IQ/OQ/PQ) protocols and calibration schedule, would suffice in reducing the finding from a major to a minor.
Major/minor based on what criteria? If a corrective action requires capital expenditure which, typically, is a longer term resolution, the auditor representing the NB (or CB) should be looking for interim containment. If an equipment is producing a "high" number of nonconforming product (why else would we buy a new machine?) it is CRITICAL for the organization to increase product inspections to ensure all of nonconforming plastic injected parts are sorted out.

Obviously, a CAB (Conformity Assessment Body) can not impose artificial deadlines that are impossible for any organization to comply with, be it for commercial reasons or long lead times for CAPEX acquisition. But, they have to "impose" robust containment actions to ensure nonconforming product does not reach the market.
 
#6
Major/minor based on what criteria? If a corrective action requires capital expenditure which, typically, is a longer term resolution, the auditor representing the NB (or CB) should be looking for interim containment. If an equipment is producing a "high" number of nonconforming product (why else would we buy a new machine?) it is CRITICAL for the organization to increase product inspections to ensure all of nonconforming plastic injected parts are sorted out.

Obviously, a CAB (Conformity Assessment Body) can not impose artificial deadlines that are impossible for any organization to comply with, be it for commercial reasons or long lead times for CAPEX acquisition. But, they have to "impose" robust containment actions to ensure nonconforming product does not reach the market.
Non-conformity raised by the NB can either be a major or a minor NC, depends on whether they see it as a systemic or an isolated deviation. According to their internal procedures (I'm talking about EU NBs), as far as I know, the major has a deadline of 90 days to be (partially) resolved and a minor has 1 year.
The example of the new machine is made up for the illustration purposes, I believe.
 

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