CAPA against Notified Body?

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#1
A possible commercial partner of ours asked about our MDR transition plan during their audit of our QMS. They asked us about our notified bodies MDR capabilities and I stated they have not yet received MDR approval.

I was wondering, I know it seems unwise, but would it make sense to open a Supplier Preventive Action against our NB for them to produce an MDR compliance plan timeline?
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Leader
Admin
#2
I know it seems unwise
It is!
but would it make sense to open a Supplier Preventive Action against our NB for them to produce an MDR compliance plan timeline?
In your profile, you mention that you work for a SMALL company. Do you really think that a Notified Body will pay attention to this request? You are entitled to know if they plan on becoming a MDR NB or not. But, to expect they will share their roadmap to MDR notification with you is ludicrous, in my opinion, especially when we realize the challenges and context of this migration.

And, thinking this through....what would you do if you issue this SPAR to the NB and they ignore it? Would you disqualify them? Would you lose your product notification? Talk about shooting oneself's foot.
 

Watchcat

Trusted Information Resource
#4
It may make sense, but it is unlikely to make a difference.

It would be more useful to have a Plan B in the event your NB does not receive MDR designation...ever, or in time for your products to be MDR-certified by May 2020, or by whatever date they need to be MDR-certified by, if they can ride an MDD certification past that date.

Also a Plan C, in case your NB not only doesn't receive MDR designation, but decides to close up shop after it hears this, since you can't ride your MDD certification without an NB to provide oversight.

And...sigh...a Plan D, in case your NB doesn't receive MDR designation, and another NB agrees to accept you, and then changes its mind, (apparently this has already happened once, with TUV and LRQA refugees).

Plan Z, you don't want to know. :(
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#5
What are other people doing? How are some companies/products not going to get caught up in this bureaucratic mess through little fault of their own?
 

Watchcat

Trusted Information Resource
#6
It would seem that there is only so much you can do at this point. NBs are profit-making enterprises, and, as far as I know, there is nothing in EU law that requires them to accept business. Most companies will choose big clients who will give them lots of business over small companies that will bring them just a little.

I would also keep in mind that, just because Business Development "accepts" your business, doesn't mean that anyone in the rest of the company is going to have time to review your application...or conduct an audit, if one is needed. (This would be my first guess as to what's behind the TUV/LRQA debacle.)
 
Thread starter Similar threads Forum Replies Date
N Preventive CAPA - effectiveness check needed? ISO 13485:2016 - Medical Device Quality Management Systems 1
A CAPA Preventive Action and Continuous Improvement 10
Y Is preventive action required for each CAPA initiated? ISO 13485:2016 - Medical Device Quality Management Systems 24
M Root Cause and Corrective Action for CAPA's lacking validation/verification ISO 13485:2016 - Medical Device Quality Management Systems 19
A Recommendations for affordable CAPA system Preventive Action and Continuous Improvement 4
D The meaning of the term CAPA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
A CAPA approach feedback 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Non conformance/complaint and CAPA ISO 13485:2016 - Medical Device Quality Management Systems 6
H CAPA effectiveness verification methods for different types of CA Nonconformance and Corrective Action 10
Azaarus Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 10
I Nonconformities and CAPA Nonconformance and Corrective Action 9
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
F NCMRs and its relation to CAPA Nonconformance and Corrective Action 7
C Projects in the CAPA system Preventive Action and Continuous Improvement 6
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
B Do you use paper or web-based templates for CAPA processes? ISO 13485:2016 - Medical Device Quality Management Systems 3
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
B CAPA - Extensions vs Overdue Nonconformance and Corrective Action 11
G New CAPA Work Flow with Revised 8D Approach Process Maps, Process Mapping and Turtle Diagrams 35
Y Blank Fields on CAPA Form Document Control Systems, Procedures, Forms and Templates 21
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
V CAPA effectiveness check Nonconformance and Corrective Action 3
CPhelan Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA? Nonconformance and Corrective Action 4
N How to monitor the effectiveness of the CAPA system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions ISO 13485:2016 - Medical Device Quality Management Systems 22
Q Raising A CAPA on Current CAPA system US Food and Drug Administration (FDA) 3
Z Security for Approvals - Cloud based Complaint, NC, and CAPA systems Qualification and Validation (including 21 CFR Part 11) 8
S FDA requirements and CAPA's Qualification and Validation (including 21 CFR Part 11) 2
J MDR reporting and CAPA thoughts? Classifying Complaints on Risk 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
P Documentation for correction, corrective action, mini CAPA Nonconformance and Corrective Action 9
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
A Can change control can be closed if the CAPA is still open? Nonconformance and Corrective Action 3
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A NCR, NCMR, CAPA, Deviations - Medical Device Distributor Nonconformance and Corrective Action 2
S CAPA Investigation Methods Nonconformance and Corrective Action 3
qualprod Should I initiate CAPA for a nonconformance not recorded? Nonconformance and Corrective Action 25
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
J CAPA and other Log Requirements ISO 13485:2016 - Medical Device Quality Management Systems 8
D Any Elsmar members using Traqpath to manage CAPA? Nonconformance and Corrective Action 2
D CAPA - Suggested Action vs Action Plan Nonconformance and Corrective Action 5
A Audit Finding - CAPA, Improvement Initiatives not filed in CAR System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Moncia Complaint / Non-Conforming Product / CAPA Procedures - Please share your experience ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Issue with CAPA system - Should Over Due CAs warrant a CAPA? Nonconformance and Corrective Action 17
K CAPA (Corrective and Preventive Action) - ISO 13485 Nonconformance and Corrective Action 1
M CAPA due to Consumer not following Maintenance Instructions... Nonconformance and Corrective Action 9
A Escalation to CAPA - Assessing if an NC warrants a CAPA Nonconformance and Corrective Action 4
P Trending CAPA's in our Management Review Meetings ISO 13485:2016 - Medical Device Quality Management Systems 1
J Software and Methods for Tracking CAPA (Corrective and Preventive Action) items US Food and Drug Administration (FDA) 3

Similar threads

Top Bottom