How to handle operator involvement in the non conformance

GoSpeedRacer

GoSpeedRacer

Registered
#1
#1
Hello fellow med. device makers.

I am looking for input and ideas regarding how to incorporate operators in the WIP, non-conformance process.

So as it goes right now, if our QC inspector finds a non-conformance he will write up a Non conforming Material Report (NCMR) and the case goes to MRB. If the MRB dispositions it to Rework, the part or assembly is (usually) giving to the operator to fix their work.
But for cases where it is Use As Is, (or scrap) or the guy that messed up is out of the office), the offending operator might not find out that they messed up.

Management wants to tighten this up by having every NCMR go to the perpetrator for signature. Also every error needs to be written up. (i.e forgot to inital and date an entry overwrite on a product log. This way they are made aware of their error and by signing the NCMR form, the operator feels a tad more "sting".

Our QC inspector feels this will make him out to be a "bad cop" as he will have to kind of "rub the offending operators nose" in every misdeed, making for more of an strained relationship. (folks may be less likely to communicate freely). He thinks it should be handled more informally so that minor issues can just be talked over, while significant quality lapses could be written up.
I think that some of the "bad cop" persona is part of the job of a QC inspector but also, one does not have to belittle of harass folks in order to do the QC job.

I also think that collecting data even on minor issues is important as it offers a chance to talk to folks before a big issues crops up. However, if we get too persnickety, some NCMR's will not be written up because the QC inspector will just fix the paperwork error himself to speed up the process (and save him from having to deal with a seemingly benign issue)
So, any ideas for a suitable compromise?

How do y'all deal with this?

Best regards

Rx
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
G

Golfman25

Trusted Information Resource
#2
#2
I think you have to determine whether the errors are:

a) systematic,
b) based on operator competence,
c) or carelessness

I would attack them in order:
If systematic, then get the operator to help revise the system to reduce the problems.

If competence is an issue, get them competent.

If it is carelessness, then make them aware.

What you want to avoid is this:
YouTube :)
 
RoxaneB

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#3
#3
Golfman25 said:
I think you have to determine whether the errors are:

a) systematic,
b) based on operator competence,
c) or carelessness

I would attack them in order:
If systematic, then get the operator to help revise the system to reduce the problems.

If competence is an issue, get them competent.

If it is carelessness, then make them aware.
Click to expand...
To build upon Golfman's post, I'd also consider the risk(s) associated with the nonconformance and the value associated with the actions needed.

Low risk and little value in chasing someone down immediately for a signature, as an example, log it and deal with it at a more suitable time. High risk and the issue needs to be addressed ASAP, then loop the appropriate people in immediately.

I'd also consider sharing the results of the nonconformances, by team or area (not by individual if at all possible). Healthy competition can be helpful at addressing what might simply laziness or can identify some serious gaps in the system.
 
E

Eredhel

Quality Manager
#4
#4
I like your hesitation btw. I know of a shop that would do an NCR tag for a machinist's scrap, have a meeting with that machinist about it, and then have a daily meeting about scrap and bring up that scrap in front of everyone. We definitely want people to know what happened so adjustments can be made but a healthy balance is important too.
 
Q

QuinnM

Involved In Discussions
#5
#5
Hi Rx,

If an operator error, the operator’s manager should perform re-training. This result should be documented in the NCMR before the NCMR is approved. Two concerns. The training should be documented. The training could be documented in the NCMR, or the formal training process. Agree, try to avoid “rubbing the operators nose” because they will / should feel open to express / expose issues when they come up. Not every issue is an NCMR. If I make a mistake it is corrected and documented, sometimes with an NCMR.

Quinn
 
RoxaneB

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#6
#6
QuinnM said:
If an operator error, the operator’s manager should perform re-training. This result should be documented in the NCMR before the NCMR is approved. Two concerns. The training should be documented. The training could be documented in the NCMR, or the formal training process. Agree, try to avoid “rubbing the operators nose” because they will / should feel open to express / expose issues when they come up. Not every issue is an NCMR. If I make a mistake it is corrected and documented, sometimes with an NCMR.
Click to expand...
I'm going to disagree here - not every operator error requires retraining. People have bad days and there are times we make mistakes simply because our heads are not truly at work. Re-training could result in a more frustrated employee who ends up becoming dis-engaged.

The other possibility involves understanding what is truly meant by "operator error." It is possible that the operator has a better process/method to perform the task, but the technology is not yet set up to align with that process/method. In this case, there is the possibility that the standard process (and associated technology) needs to be revised.

I know we sometimes roll our eyes at the philosophy that "it's never operator error" even though there are instances when we believe it truly is, however, this doesn't mean that we should simply stop at "operator error" when investigating the real reason behind the nonconformance.

I'm also a bit confused by your response. In one paragraph you say that the training should be documented in the nonconformance report, but then you say that not every issue warrants a nonconformance report. Please don't misunderstand me - I fully support the approach that not every nonconformance requires a nonconformance report; if it did, we'd be bogged down in paperwork! But I think you should explain your statement to the original poster. The approach I take to determine if a report is needed involves the use of triggers and statistics, but your reasoning may be different and I think it would be interesting to learn the logic behind it. :cool:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T How to handle out-of-scope activities. ISO 13485:2016 - Medical Device Quality Management Systems 7
K Different Indications for Use in Different Countries -- how to handle IFU? Other Medical Device Regulations World-Wide 4
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
I How to handle pending FSN when incident happens? EU Medical Device Regulations 1
Jimmy123 Process disturbances and the repair - How do you handle this risk in your company? FMEA and Control Plans 18
A How to Handle Documented Information in an online database for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O How will you handle Clause 6.1 - Risks and Opportunities for AS9100 Rev. D Auditors? Risk Management Principles and Generic Guidelines 22
V Systems to Handle Development and Batch Analysis in same Laboratory Qualification and Validation (including 21 CFR Part 11) 3
dubrizo How do you handle damaged IM&TE in your organization? General Measurement Device and Calibration Topics 3
D MDD Classification of Bone Saw Handle ISO 13485:2016 - Medical Device Quality Management Systems 1
1 How to handle Nononformances in Clincal Manufacturing ? Nonconformance and Corrective Action 2
R How do we handle Training during transition and overlap from one system to other ? Training - Internal, External, Online and Distance Learning 4
Q How to handle different voltages for different countries Document Control Systems, Procedures, Forms and Templates 1
A How to handle complaints after end of specified medical device life-time ISO 13485:2016 - Medical Device Quality Management Systems 5
M How does Australia handle products that are EU PPE, but Australia Medical Devices? Other Medical Device Regulations World-Wide 7
C How to handle this Inspection conflict? Second Shift Inspector? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T How to handle Demo Units during an ISO 9001 Audit General Auditing Discussions 3
C ISO 9001 Nonconformances an how to handle them ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D How to handle a blood stained GMP document ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
T How to handle 510(K) submisison in 2014 when the Fees were paid in FY13 ? US Food and Drug Administration (FDA) 3
C How to handle Action Results in a new FMEA Review once we have a new RPN? FMEA and Control Plans 1
Mikishots How to handle CAR (Corrective Action Request) Scope vs. Timely Response Nonconformance and Corrective Action 9
J Quality Procedure to handle some standard Medical Device Processes Document Control Systems, Procedures, Forms and Templates 1
L How to handle a Business Shutdown - Business Dissolution 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Plan & Procedure to handle a Product that's being Withdrawn from the Market 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Can you handle passivated parts without wearing gloves? Manufacturing and Related Processes 5
A How to handle the various Document Revisions Document Control Systems, Procedures, Forms and Templates 2
N How to handle Quality and Safety Deficiencies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Client that refuses to help - How to handle ? Misc. Quality Assurance and Business Systems Related Topics 5
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B How to handle Medical Device Emergency Software Releases Software Quality Assurance 4
B How to handle/follow supervisor and department head with different supervisory style? Quality Manager and Management Related Issues 7
Z If this is a Nonconforming Product (Service) under clause 8.3? How do we handle it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Responsibility of Distributor for Customer Complaints - How should we handle this Customer Complaints 5
R How to Handle 'Scrap and Replace' of Non-Conforming Products Nonconformance and Corrective Action 9
B Upper Management makes changes to a report - How do I handle this? Six Sigma 12
J SOP for How to Handle an Investigation wanted Document Control Systems, Procedures, Forms and Templates 1
J AS9100 C - 7.5.1.3 - How do you handle Production Equipment Maintenance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
J Seeking advice on how to handle a Special Process Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
M How to handle the task of Organizing a Regulatory File Room Document Control Systems, Procedures, Forms and Templates 2
V ISO 26262 - How to handle OEM ASIL A (Automotive Software Integrity Requirements) Other ISO and International Standards and European Regulations 4
M How to handle Rejections of a Internal NCR event Nonconformance and Corrective Action 7
G Manufacturing Process Subcontracted - How do I handle Cl. 7.5? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
P How to handle Out of Tolerance during Calibrations and exceeded Alert Action Limits Quality Manager and Management Related Issues 4
M The importance of Document Control? How do you handle your Document Control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R How do you handle 'Contaminated Wood Pallets'? US Food and Drug Administration (FDA) 16
L Quality Objectives - How various device companies handle "Quality Objectives" ISO 13485:2016 - Medical Device Quality Management Systems 9
A How does your registrar handle 2 certificates, one for AS9100 and one for ISO9001? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
Le Chiffre Great article on how to handle continuous improvement Quality Manager and Management Related Issues 3

Similar threads

Top Bottom