Ask A Quality Professional

1.  Determining Disposition of Non Conforming Product

Posted 12 days ago
​​Hello,

We are a small medical device company located in the Midwest.  I am wanting to improve our NCR process and am leaning towards forming a cross functional team to review NCRs for final disposition.

Our current process usually comes down to an argument between Quality and Operations/Production.

I am very interested in how other companies process their non conformities.

thank you,

Jill



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Jill Trebil
Quality Manager
De Smet SD
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2.  RE: Determining Disposition of Non Conforming Product

Posted 11 days ago

For those of you that may be a bit stressed this morning, I offer a bit of Quality v. Production humor.

QA motto: When in doubt, throw it out.

Production motto: When in doubt, ship it out.

 

All the Quality people chuckle and the Production folks groan..

 

On the serious side.. I am not familiar with medical device regulations, but it would seem that if there are arguments, then perhaps the requirements are not as clearly defined as they could be.

Allowed dispositions are clearly defined in  the various standards..

  1. Rework/ repair to bring into compliance
  2. Scrap
  3. Use-as-is with Customer approval where needed
  4. Re-grade the product to a classification it complies to.

 

A form of waste is to 'over specify' a product.  This is where a well defined set of technical, regulatory and customer requirements and needs is essential.

It will give all parties a clear set of standards against which to make dispositions. I don't think the 'who' is nearly as important as the 'why' in identifying disposition.

 

When considering disposition, typically, Quality clearly identifies the nonconformity and provides pertinent information regarding it.

Production and/or Manufacturing Engineering determine if it can be brought into compliance and at what cost.

Product Engineering typically determines if use-as-is is acceptable.

Quality and/or Sales/Customer Service typically perform the customer notification/ approval process.

 

With a medical device, someone from legal may need to give input depending on the product risk.

 

Hope this helps..

 

Audrey Ehrman

Sr. Quality Technician, III

ASQ CMQ/OE, ASQ CQE

https://prdweb.asq.org/certification/resource/images/2012CertManQ_OrgEx.jpg

 

725 E University Dr

McKinney, TX 75069

Phone: 972.547.6020 : Ext 1262

FAX: 972.542.0097

 

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3.  RE: Determining Disposition of Non Conforming Product

Posted 10 days ago
Hi Audrey and Jill,

I've worked in medical devices & the MRB / NCMR process for quite awhile.  The basic NCMR process is the same, the differences are whether the product needs to be reworked in order to be brought into conformance and whether we're talking about components and materials, sub-assemblies, or finished goods.

Recording the non-conformance, its evaluation, and disposition is essential to the process.

A cross functional team is a good idea, at least for reviewing and approving the material disposition (but don't get carried away here, more approvers means that the process could be slower).  The NCMR is primarily a technical assessment of an item vs. its specification or drawing, therefore the evaluation and recommendation needs to be done by someone with appropriate technical education, training, or experience- therefore knowledge of the product and how it works is important.

Some key points are:
1. Is the nonconforming material produced by a validated process?  If yes, in addition to dispositioning the material, the process may need to be revalidated.
2. If the nonconforming material will be sorted, what is the method for sorting or inspection, could sorting / re-inspection miss nonconformities (how will this be prevented?), and could the additional handling introduce other problems or non-conformities.
3. If the nonconforming material will be reworked or repaired, there needs to be written instructions for how this will be done, how will the reworked/repaired material be brought into conformance, and will doing this introduce a new problem or non-conformity.

For medical devices, the key is to determine whether the item conforms to its Device Master Record (i.e. specification or drawing), can it be sorted or reworked to conform to the DMR, are we deviating from a validated process, do we need to repeat qualifications (in addition to process validation consider that design verification might need to be repeated or a rationale for why this isn't necessary).  And, are the required records being kept for the Device History Record (DHR).  The NCMR is a required record for the DHR.

MRB always seems to be a contentious process, so try to keep everyone focused on the facts.  What is the nonconformity and how might it affect the device's function?  Does this impact the patient and/or the users?

--
-Joe Wojniak





4.  RE: Determining Disposition of Non Conforming Product

Posted 8 days ago
Current Device Master Record (DMR) drives medical device manufacturing and servicing acceptance criteria to ensure compliance with regulations and  regulatory submissions (intended use) for manufacturing safe and effective medical device. Device History Record provides objective evidence for any nonconformity acceptance and final tests to manufacure a safe and effective device for intended purposes.