ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay'

#1
Hi Masters of Medical Devices.
I struggle to solve issue regarding timing required around closure of CA. Standard citate 'Any necessary CA shall be taken without undue delay'.
Certification Auditor insisted that we shall have timings assigned for each stage of the nonconformance process. I think sometimes you cannot close an NCRs, develop CA if you are for example dependant on external factors, or simply you just need more time to agree on CA. I would like to find out what would be the best way comply with above clause without having to assign exact timings in procedure?
Any advise would be greatly appreciated
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#3
Certification Auditor insisted that we shall have timings assigned for each stage of the nonconformance process.
Please clarify, is the auditor saying:
  • In your CAPA process there should be predefined time intervals for each stage, for all CAPAs?
  • Or, is the auditor saying that each CAPA should have an estimated due date set for each stage? (I.e., if you have no due dates, then there is no measure for timeliness.)
 
#4
Please clarify, is the auditor saying:
  • In your CAPA process there should be predefined time intervals for each stage, for all CAPAs?
  • Or, is the auditor saying that each CAPA should have an estimated due date set for each stage? (I.e., if you have no due dates, then there is no measure for timeliness.)
Auditor says it should be defined in our CAPA as it is not okay to assign individual timings to NCR. I really wish we could change our Auditor but apparently she is egger to see us every year....
 
#6
Did the auditor cite any evidence of "undue delay"?

If not, why did you agree that this was a nonconformity?
She citate a lot of internal NCRs that were due to different factors and closed at different times.
Unfortunately the person who agreed to those findings is no longer with the company.
Now I need to carry out the internal audit I'm trying to make a suggestion to change the procedure as it not feasible for the organisation to have assigned 30 days for CA and 60 days for effectiveness check from the day of NCR raised.
But I also don't want to change Procedure much because it was accepted as part of Certification Audit finding...
 

John Broomfield

Staff member
Super Moderator
#7
I would be amazed if your NCRs were not closed out at different times. I guess you are saying they were late when compared with the self-imposed standardized deadlines.

Given the 30 and 60 day deadlines, your current corrective action (CA) procedure is ineffective but such deadlines are not required by the standard.
If you look at the history of this process and its procedure you may find that it suffered habitual delays and the documented procedure was changed (but with no buy-in) in a feeble attempt to impose deadlines. You may also find that some of the same NCs have recurred because folk were chasing deadlines instead of determining and removing the root causes.

Make sure you have researched the legal requirements and the history of this procedure before you engage top management in upgrading the process to fulfill their requirements. As they do this your research should enable you to ensure it conforms with the standard and complies with all relevant legal requirements. Engagement means you reasonably expect your colleagues to respect the need for timely corrective action.

They may welcome the option to specify a target date to complete the investigation according to the complexity of the problem and then to specify and target dates for removing each of the root causes.

Keep a record of your research to remove the root causes of this problem. One of which may be the lack of engagement to change the process so it conformed to the doc change.

Lastly, you've not mentioned containment to immediately limit the impact of the nonconformity while allowing time to do effective CA. Are the containment actions working well?
 

AMIT BALLAL

Trusted Information Resource
#8
I would suggest determining a timeline for correction and root cause analysis. And deciding corrective action target date based on root cause & action(s) required for each NC separately in NCR. You can incorporate this in your procedure.

Then, delay beyond these timelines can be considered as "undue delay".
 

Tagin

Trusted Information Resource
#9
Auditor says it should be defined in our CAPA as it is not okay to assign individual timings to NCR. I really wish we could change our Auditor but apparently she is egger to see us every year....
There is no requirement to assign identical timings to every NCR. It's an absurd, unrealistic idea. Challenge the auditor to show you where that is stated in the standard.

She citate a lot of internal NCRs that were due to different factors and closed at different times.
Unfortunately the person who agreed to those findings is no longer with the company.
Now I need to carry out the internal audit I'm trying to make a suggestion to change the procedure as it not feasible for the organisation to have assigned 30 days for CA and 60 days for effectiveness check from the day of NCR raised.
But I also don't want to change Procedure much because it was accepted as part of Certification Audit finding...
In your procedure you could:
  • State default times for CAPA stages (#days for containment,#days for correction,#days for root cause, etc.)
  • Provide a mechanism in the procedure for the times on an individual CAPA to be increased as needed (e.g., maybe require a) justification reason, and b) approval of someone).
 

Big Jim

Super Moderator
#10
Auditor says it should be defined in our CAPA as it is not okay to assign individual timings to NCR. I really wish we could change our Auditor but apparently she is egger to see us every year....
It doesn't matter if the auditor is eager to return or not, it is YOUR choice, not theirs. Let this inexperienced one go and obtain her education tuition elsewhere, not at your expense, especially since they don't seem to be eager to learn correct principles.
 
Thread starter Similar threads Forum Replies Date
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
L ISO 13485:2016 Clause 8.4 - Analysis of Audit Observations ISO 13485:2016 - Medical Device Quality Management Systems 8
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
JoshuaFroud Interpretation of Clause 5.5.2 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S What is the clause in ISO 13485 for SAP Software Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Damaged Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 7
GoSpeedRacer ISO 13485:2016 Clause 4.2.5 - Control of Records - HIPAA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 11
T Struggling with ISO 13485:2016 Clause 6.2 - Level of Risk Associated with Work ISO 13485:2016 - Medical Device Quality Management Systems 3
T ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements ISO 13485:2016 - Medical Device Quality Management Systems 11
R ISO 13485:2016 Clause 6.2 - Effectiveness Check ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 Clause 7.3.2 - Purchased Data Approval and Record Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
SteveK Interpreting clause 4.1.5 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 9
SteveK Software Validation – Clause 4.1.6 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 12
P Which ISO 13485 clause(es) are applicable for Value Proposition Creation ISO 13485:2016 - Medical Device Quality Management Systems 1
J Definition Servicing - Definition - ISO 13485 Clause 7.5.1.2.3 - Servicing Activities Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
T ISO 13485 Clause 4.2.1 - Clarification of Intent ISO 13485:2016 - Medical Device Quality Management Systems 6
R ISO 13485 Clause 4.2.1 - Documentation Requirement question ISO 13485:2016 - Medical Device Quality Management Systems 4
D Taking an Exception to Clause 7.3 in ISO 9001 and ISO 13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
X Help with ISO 13485 Clause 8.3 "Rework" as applicable to Medical Device Servicing ISO 13485:2016 - Medical Device Quality Management Systems 39
X Help with ISO 13485 Clause 6.4 as it applies to Medical Device Servicing ISO 13485:2016 - Medical Device Quality Management Systems 25
C ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Question ISO 13485:2016 - Medical Device Quality Management Systems 7
Project Man The "Ifs" in ISO 13485 Clause 6.4 Work Environment - Machine Shop which makes parts ISO 13485:2016 - Medical Device Quality Management Systems 1
A Human Resources (ISO 13485 Clause 6.2) example of SOP ISO 13485:2016 - Medical Device Quality Management Systems 1
T Quality Staff - Independence (ISO 13485 Clause 5.5.1) ISO 13485:2016 - Medical Device Quality Management Systems 1
P Control of Monitoring and Measurement Devices - ISO 13485 Clause 7.6 says ... ISO 13485:2016 - Medical Device Quality Management Systems 3
A Purchasing Information Requirements - ISO 13485 Clause 7.4.2 and FDA QSR Supplier Quality Assurance and other Supplier Issues 2
D Quality System Manual - Exclusions from ISO 13485 Clause 7.5 ISO 13485:2016 - Medical Device Quality Management Systems 4
N Validation of Special Processes - N/A of ISO 13485 Clause 7.5.2 ISO 13485:2016 - Medical Device Quality Management Systems 12
I Not having Training Records for Documentation Changes - ISO 13485 Clause 4.2.3 Document Control Systems, Procedures, Forms and Templates 22
J ISO 13485 Clause 1.2 Application Clarification ISO 13485:2016 - Medical Device Quality Management Systems 1
K ISO 13485 Clause 7.4 Purchase Order Requirements Question ISO 13485:2016 - Medical Device Quality Management Systems 4
somashekar Calibration interval (Clause 7.6 ISO 13485:2003) - Biomedical test instruments ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 Clause 7.6 Control of Monitoring and measuring devices - Requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
Q Interpreting Responsibility and Authority Clause 5.5.1 ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 18
Q ISO 13485 Clause 4.2.2 Documentation Structure - Quality Manual clarification ISO 13485:2016 - Medical Device Quality Management Systems 6
R Interpretation of ISO 13485 Clause 8.4 - Analysis of Data ISO 13485:2016 - Medical Device Quality Management Systems 20
J ISO 13485:2003 Clause 1.3 - Applicable Standards and Regulations ISO 13485:2016 - Medical Device Quality Management Systems 8
N Poor control of testing chemicals ? which ISO 13485/9001 clause does it contravene? ISO 13485:2016 - Medical Device Quality Management Systems 8
J How to accomplish ISO 13485 Clause 8.2.3 Monitoring and Measuring? ISO 13485:2016 - Medical Device Quality Management Systems 5
F ISO 13485 Clause 6.3 - System to determine and provide infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 5
V Planning of Product Realization - Risk Management - ISO 13485 Clause 7.1 ISO 13485:2016 - Medical Device Quality Management Systems 6
D Effective Control of Processes - ISO 13485 Clause 4.2.1 (d) ISO 13485:2016 - Medical Device Quality Management Systems 2
A ISO 13485 Clause 8.2.2 - Internal auditor from within the company to be audited Internal Auditing 2
L ISO 13485: 2003 - Clause 8.4 Analysis of Data - Seeking an example procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
H New Clause Structure of ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 5
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom