Priorizing Non-conformances - What is the best way?

S

Stormy

#1
Good Day,

I am wondering if anyone has suggestions on how to priorize non-conformances? I have looked in the other forums at this site, but I haven't found anything about priorizing ncr's.
My goal is to minimize the amount of corrective actions that are dealt with. At this time we use a single form for NCR/corrective actions and we address almost every ncr with a corrective action. This method allowed us to pinpoint where our repeatable processes were, and to pinpoint any missing instructions that would deal with regular non-conformances. But we are now at the point that we feel we should streamline the system, and concentrate on the larger issues.

I hope I haven't confused everyone with this description.

So if anyone has any suggestions, they would be appreciated.

Thanks. :bigwave:
 
Elsmar Forum Sponsor

Mike S.

Happy to be Alive
Trusted Information Resource
#2
Stormy,

Your problem is a common one -- one that most companies have had to deal with already, or soon will have to deal with. In fact, this issue has been discussed several times here in the last year. Use the search function to look for threads with the words "corrective action" or "CAR", etc. and I know you will find tens of posts with many opinions. If memory serves (not a given!), I think the consensus was that not every NC requires a formal CA; that sometimes "human error" is an acceptable cause; and that prioritization is usually based on risk of recurrance and potential impact.

If you can't find what you're looking for in a search, write back and ask some specific questions and you'll get answers.
 
T

Tim Douty

#3
Prioritizing Nonconformances

Stormy,
I am sure you take on the major nonconformances before the minors. My rule of thumb is this - each nonconformance is prioritized by the importance to the end product, I work backwards from there. I base alot of priority on our Lead Auditors preferences as well. I tackle the Lead Auditor's "hot buttons" first! I may be different than most, but I write a corrective action for each nonconformance. I feel it may be more cumbersome up-front, but later, it helps track the entire process - sort of "cradle to grave". I hope this aids to your inquiry.
Tim
 
S

Stormy

#4
Good Day,

Ted, thank you for responding.

This is my problem: we haven’t yet defined what constitutes a major vs. a minor. You said prioritize by the importance to the end product, but what is your definition of what is important to the end product? What are the criteria that you use, and how did you choose what was the most important factors?

In a different thread in this category a guy by the name of Ken Madder wrote “They were treating every cause as a Special Cause when in fact, most were Common Cause”. I would love to know how he defines Special vs. Common.

I am beginning to prioritize some of our NCR’s, by defining non-conformances that are repeatable up to a certain quantity, and recording those on a data excel sheet. The data is then evaluated monthly. This is where I have trouble. I can use total footage & the amount of the occurrences to decide which repeatable is causing the most non-conformances, and begin a non-conformance report on the highest footage and/or highest occurrence. But in doing this am I missing the non-conformances that are important to the customer? And it isn’t clear how I can carry this type of prioritizing into the non-conformance process?

So I am still searching for clarity, I guess.

But thanks again for replying.:bigwave:
 
M

M Greenaway

#7
Stormy

The process is quite simple (well simple to outline).

Log every complaint in some form of database, and assign a code either to the reported complaint, or to the root cause if you wish to spend time at this point investigating every root cause (I would suggest you do personally).

Take the data from a suitable period of time that gives you a sufficient chunk of information, maybe 3 months. Count the fault or cause codes, arrange the counts in descending order, then simply prioritise your action on the most common occuring reported fault or cause.

This approach is OK, but slightly flawed if different complaints or products have different costs associated with them. Arguably a better approach would be to establish the cost of the complaints, and then target actions to the most costly.
 
Thread starter Similar threads Forum Replies Date
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
D IATF 16949 SI 10, External non-accredited lab IATF 16949 - Automotive Quality Systems Standard 4
M Selling non-CE marked devices for evaluation EU Medical Device Regulations 4
T Non API products need to comply to API Q1? Oil and Gas Industry Standards and Regulations 3
L "Shelf-Life" Class I Non-Sterile Products Expiration Date? CE Marking (Conformité Européene) / CB Scheme 3
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
N How to find column number for the last non-empty column? Using Minitab Software 0
A Need to calculate tolerance Intervals with a set of non-normal data and 3-Parameter Weibull distribution Using Minitab Software 0
3 Non-conformance Register vs Corrective Action Register ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
G Competent Authority non-EU Manufacturer EU Medical Device Regulations 7
F Non conforming locked? Manufacturing and Related Processes 13
M Changing Investigational Device from Non-Sterile to Sterile - what are the implications? Other Medical Device and Orthopedic Related Topics 3
K Is Calibration Required for Non-Adjustable Commercial Inspection Devices? General Measurement Device and Calibration Topics 11
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
G Not accepting a non conformity during an audit General Auditing Discussions 11
J In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply? UK Medical Device Regulations 6
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
A Brexit Mandate for EU Authorised Representative for non medical devices CE Marking (Conformité Européene) / CB Scheme 7
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 4
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
B Procedure packs with non-medical devices EU Medical Device Regulations 1
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
S Advice on how to reduce overhead of handling non-conforming material Nonconformance and Corrective Action 7
G Team to analyze a non conformance Customer Complaints 26
J Promoting and marketing of a non approved device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
G 0 non conformities in registrar audits over 4 years Management Review Meetings and related Processes 12
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
P Ppk results shown as asterisk after the transformation of Non-normal data Using Minitab Software 4
I When is necessary to have RoHS declaration on non-electrical parts? REACH and RoHS Conversations 1
Johnnymo62 Non Aerospace topics - Anything for military trucks, trailers, Humvee type vehicles? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 1
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Non-Conformances Found After 3rd Party Sorting Supplier Quality Assurance and other Supplier Issues 12
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
N Competent Authority notification for non-EU manufacturer EU Medical Device Regulations 4

Similar threads

Top Bottom