Non-functional Corrective Action - Could Not Find some Documents

itsbiodiversity

Involved In Discussions
#1
I started a new job a few months ago as QM from a retiree who did not keep up with things the way they should have. Prior to even glancing at a document I was hit with an internal audit that requested our CAPAs...well I could not locate them so we got a Corrective Action. For my Corrective Action I notified the auditor that since I was new I could not locate the files, they were located, completed, etc etc. I also updated the verbiage to ensure that I received the complaints and could manage them directly.

Now with my External Auditor (registrar) he thinks that's a pretty sorry excuse and wants another Corrective Action on what I suppose is my "newness" to the job at the time...because at this point there's not much I can do to improve the Corrective Action system it would seem. We are a small company and making great headway and listening to customer concerns. I did create a customer communication log to track any repetitive issues.

Can someone help me determine a root cause? My root cause of starting new and having another person's system in place on that date didn't please the auditor one iota.

Thanks.
 
Elsmar Forum Sponsor
P

PaulJSmith

#2
It might be helpful to know exactly what requirement your external auditor is citing as non-conforming.

As to the first audit, it sounds to me like you may have some internal issues which need to be addressed.
 

Golfman25

Trusted Information Resource
#3
So let me get this straight. You're on the job at a small company for a few weeks and boom they hit you with an internal audit. (Who in their right mind would do that?) You fumble around looking for some documents because you are still learning how the company and how your predecessor operated. The "auditor" issues a corrective action. You eventually find everything, update and "correct" the system.

Now some external auditor arrives and determines that the substance of your "root cause" analysis and corrective action is insufficient. So now, even though it seems you fixed any issues you need to redo. That's helpful.

Here is your root cause: You're internal/external auditors are _______ (fill in the blank). :)

To me there is no substance in either of the "findings." I would be more concerned with how your system is working today, under you're supervision than any hiccup while you where learning the ropes. And people wonder why ISO gets a bad rap. Good luck.
 

somashekar

Staff member
Super Moderator
#4
I started a new job a few months ago as QM from a retiree who did not keep up with things the way they should have. Prior to even glancing at a document I was hit with an internal audit that requested our CAPAs...well I could not locate them so we got a Corrective Action. For my Corrective Action I notified the auditor that since I was new I could not locate the files, they were located, completed, etc etc. I also updated the verbiage to ensure that I received the complaints and could manage them directly.

Now with my External Auditor (registrar) he thinks that's a pretty sorry excuse and wants another Corrective Action on what I suppose is my "newness" to the job at the time...because at this point there's not much I can do to improve the Corrective Action system it would seem. We are a small company and making great headway and listening to customer concerns. I did create a customer communication log to track any repetitive issues.

Can someone help me determine a root cause? My root cause of starting new and having another person's system in place on that date didn't please the auditor one iota.

Thanks.
I would suggest you add that you need to review and understand the document control and records control procedures as well, and find out if they are not respected.
 

itsbiodiversity

Involved In Discussions
#5
You pretty much summed it up. I even have added a customer communication log to show adherence to 17025. I feel like it is getting a corrective action for not being able to locate a retiree's file on his personal computer. My corrective action was basically to redirect the complaints via a file to the QM for registration in to the capa system. I thought it solved the issue and my root cause was clearly my predecessor's storage locations of files without the higher ups knowing where he stored them.

So if anyone has any help finding a root cause for this issue that would be presentable, and especially a solution that would be great. Any information to lead me in the right direction would be appreciated.

Thanks again for the help and reassurance.
 

Wes Bucey

Prophet of Profit
#6
You pretty much summed it up. I even have added a customer communication log to show adherence to 17025. I feel like it is getting a corrective action for not being able to locate a retiree's file on his personal computer. My corrective action was basically to redirect the complaints via a file to the QM for registration in to the capa system. I thought it solved the issue and my root cause was clearly my predecessor's storage locations of files without the higher ups knowing where he stored them.

So if anyone has any help finding a root cause for this issue that would be presentable, and especially a solution that would be great. Any information to lead me in the right direction would be appreciated.

Thanks again for the help and reassurance.
Would it be possible to give us the exact quote of the outside auditor's finding? With that, we can give you a precise response to include a

  1. root cause
  2. proposed solution
  3. method of periodically evaluating the solution to confirm it does, indeed, provide a continuing, workable process to prevent ANY documents from being irretrievable.
 

Wes Bucey

Prophet of Profit
#9
XXXXX had # (small #) of corrective actions for the year. Both had shallow RCA performed and did not find true root cause.
HOW does this auditor KNOW the "true root cause" was not found? I recognize that many auditees say "operator error - operator retrained" which would rankle ANY auditor, but WHAT did your organization say was "true root cause?" What process did your organization offer to eliminate [or substantially reduce] recurrence? How does your organization propose to periodically evaluate this process to assure it works?

There are many auditors who are jerks, but most are not. It can really rub salt into a wound when an auditee tries to "jawbone" an explanation or excuse without documentation.
 

Golfman25

Trusted Information Resource
#10
XXXXX had # (small #) of corrective actions for the year. Both had shallow RCA performed and did not find true root cause.

Was a RCA even required? Not every corrective action needs a full blown RCA. Has there been a reoccurrence?

And besides, your corrective action is already in place -- YOU.
 
Thread starter Similar threads Forum Replies Date
F Functional connection between ME and non-medical equipment in different rooms IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 27
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

Similar threads

Top Bottom