SOP - Unforeseen Circumstances (Waiver) Procedure

M

MichelleH

#1
Hi all,

Does anyone have the experience with procedure called "Unforeseen circumstances"?
This procedure should cover every case when we have to do something outside the procedures of the QMS- there is a danger that it can be done unsafely.

This procedure was recomented by the auditor : "You need an SOP to cover how you deal with every case where the QMS does not make a provision. It needs a record document that specifies the “unforeseen circumstance” and the action that is to be taken to ensure the situation is handled safely."

Can you please provide the example for this kind of procedure?

Thank you
 
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S

SteveK

#2
Re: SOP - Unforeseen Circumstances

Hi Michelle,

Is this not a CAPA procedure or covered in one - which you should have as part of e.g. ISO 9001? The scope of my CAPA procedure states:

"This procedure applies to identified product, process, system nonconformities and problematic performance with respect to internal quality, manufacturing, customer complaints, work safety issues and discrepancies cited during internal audits and external audits (e.g., ISO, MDD, Supplier) at the company’s facilities."

i.e. Unforeseen Circumstances.
:2cents:

Steve
 

sagai

Quite Involved in Discussions
#3
Re: SOP - Unforeseen Circumstances

It needs a record document that specifies the “unforeseen circumstance”
:lmao: what a heck is that? ROFL :lol:

It shall be the CAPA procedure, I guess.

br.
Sz.
 

Pancho

wikineer
Super Moderator
#5
Re: SOP - Unforeseen Circumstances Procedure

Hi all,

Does anyone have the experience with procedure called "Unforeseen circumstances"?
This procedure should cover every case when we have to do something outside the procedures of the QMS- there is a danger that it can be done unsafely.

This procedure was recomented by the auditor : "You need an SOP to cover how you deal with every case where the QMS does not make a provision. It needs a record document that specifies the “unforeseen circumstance” and the action that is to be taken to ensure the situation is handled safely."

Can you please provide the example for this kind of procedure?

Thank you
As others, most of our "unforseen circumstances" are handled through NC and CAPA, but we also have a simple procedure called "Waiver of internal requirement" which allows senior management to waive a requirement of our QMS if it conflicts with a client requirement.

The procedure is seldom used. In one case a client decided to formally forgo review of our drawings. Our QMS does not allow manufacturing to proceed without client's signed approval on the drawings. The "Waiver of internal requirement" procedure and associated record allows us to proceed with the manufacture in this unusual circumstance.

We could, of course, modify the approval procedure itself, but then we would have a much more complex procedure that would only help cases that are extremely rare.
 
M

MichelleH

#6
Re: SOP - Unforeseen Circumstances Procedure

As others, most of our "unforseen circumstances" are handled through NC and CAPA, but we also have a simple procedure called "Waiver of internal requirement" which allows senior management to waive a requirement of our QMS if it conflicts with a client requirement.
Thank you this is exactly what I´m looking for.

Sometimes our customer want us to do something which is in conflict with QMS - not approved product to be shipped, different packaging (than approved) to be used etc.
Last time our production followed customer "special" requirement (extra parts in the box) but nobody think about the risk of crushing some pieces or how to label not standard packaging (labeling based on standard box qty is done through barcodes generated automaticaly from our system).

Do you have the example of such a procedure?
 

Pancho

wikineer
Super Moderator
#7
Re: SOP - Unforeseen Circumstances Procedure

Here's an excerpt from our procedure:

1. Request for Waiver.
If a member of the Management Committee sees the need to excuse our product from any of the requirements of the QMS because of internal conflict between that requirement and other applicable requirements, he or she may request an exemption from the internal requirement using [FO: Request for Waiver of Internal Requirement]. The waiver request must be completed and approved prior to bypassing the subject internal requirement.

2. Approval / Rejection.
Before proceeding with the waiver, the request shall be approved by a second member of the Management Committee:
2a. for the engineering process: If the waiver request involves the engineering process, or exemption in other processes from engineering requirements, only the (named executives/posts) may approve it.
2b. for (other critical processes): the waiver may be approved only by (named executives/posts).

3. Implementation.
If the exemption is
3a. Approved, the internal requirement need not be met.
3b. Rejected, the internal requirement shall be met.

4. Filing.
The approved or denied request is filed in the internal project wiki indexed on a page titled [Exemptions from QMS requirements].


The [FO: Request for Waiver of Internal Requirement] form has the following fields:

  • Project
  • QMS document
  • Waiver required
  • Why is a waiver required
  • Conditions of waiver
  • Consequence of waiver
  • Requested By, date
  • Approved By, date
 

sagai

Quite Involved in Discussions
#8
Re: SOP - Unforeseen Circumstances Procedure

Have never seen such, but it is time to learn. :)
In medical devices, as long as I saw Michelle is in that industry, I would take special care that the waiver itself not to be a documented proof of non conformance with the hell of a lot standards we have here and in its approval route the QM should be involved.
br
Sz.
 
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