SBS - The best value in QMS software

Corrective and Preventive Action - State Maximum time for follow-up required?

  • Thread starter EtobiLad - 2009
  • Start date
Jim Wynne

Jim Wynne

Staff member
Admin
#11
#11
Re: Corr. and Prev Action, do you have to state the maximum time for follow-up?

EtobiLad said:
Thanks wayne,
Well in our procedure the minimum to follow-up with the action was 4 weeks to see effectiveness. I do not see this as the maximum.. :bonk: but rather should it be stated like to be followed up within the minimum and the maximum period?
Click to expand...
Well, there's no need to specify an all-encompassing time period in the procedure; you can just say "reasonable," then set a time for followup for each instance, doing whatever makes sense. In some cases you can verify effectiveness immediately, and it others you might not be able to do it for months, or ever. If the auditor says you have to have a "maximum" time specified in the procedure, ask him/her the magic 3-word question: Where's the beef "shall"?

EtobiLad said:
"the review of actions taken: not defined in the procedure as to the maximum time allowed, no evidence seen for verification. "
Click to expand...
I suspect that what the auditor was getting at was the absence of any guidance as to when followup should take place, as opposed to looking for some specific time period.
 
Last edited:
Free Trial of DISCUS Desktop
Elsmar Forum Sponsor
F

fuzzy

#12
#12
Re: Corr. and Prev Action, do you have to state the maximum time for follow-up?

EtobiLad said:
But should I be written up for these? for no maximum stated.
Click to expand...
Not in my opinion...what was that other phrase; no evidence seen for verification? :confused: Of any CAR's? Of the the one or two the auditor selected? :frust: More information would help me feel more certain about my "NO".:2cents:
 
E

EtobiLad - 2009

#13
#13
Re: Corr. and Prev Action, do you have to state the maximum time for follow-up?

Crusader said:
Does your form have a place for the due date of the corrective action? A maximum time should not be stated in a procedure but a required response date could be stated on the form.
Click to expand...
No we do not, but only a place after the actions are taken and signed and dated by the individual. Nothing regarding response date...

Cari Spears said:
Yeah - that's what we do. We determine approximately how long it will take to implement the action and how long it will need to be in place before we can determine the effectiveness. Sometimes we extend the date for various reasons.

Yeah - and the clause cited. Was this an external or internal audit?
Click to expand...
But my question is against what requirement. This was and internal audit (3rd party consultant if you may)
 
F

fuzzy

#15
#15
Re: Corr. and Prev Action, do you have to state the maximum time for follow-up?

EtobiLad said:
No we do not, but only a place after the actions are taken and signed and dated by the individual. Nothing regarding response date...



But my question is against what requirement. This was and internal audit (3rd party consultant if you may)
Click to expand...
There are no requirements to have due dates / minimum or maximum follow-up dates/ or pink colored forms :notme:. Read the Standard and make your system work for you.:mad:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
L Separate Corrective Action and Preventive Action Procedures ISO 13485:2016 - Medical Device Quality Management Systems 13
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
B Stakeholder Initiated Corrective and Preventive Action Misc. Quality Assurance and Business Systems Related Topics 5
B Corrective and Preventive Action (CAPA) A Key Process of the Quality Management System Dec 17... Training - Internal, External, Online and Distance Learning 0
J If Corrective and Preventive Action were truly Effective IATF 16949 - Automotive Quality Systems Standard 3
K CAPA (Corrective and Preventive Action) - ISO 13485 Nonconformance and Corrective Action 1
J Software and Methods for Tracking CAPA (Corrective and Preventive Action) items US Food and Drug Administration (FDA) 3
A Preventive Action or Corrective Action - Paper cuts Nonconformance and Corrective Action 14
M Corrective and Preventive Action - Prevent Recurrence is not Preventive Action? Nonconformance and Corrective Action 24
K Definition Correction, Corrective Action and Preventive Action - Definition of terms Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 28
F Software recommendations for corrective and preventive action Quality Assurance and Compliance Software Tools and Solutions 2
K Corrective and preventive action for Non Conformance on PFMEA FMEA and Control Plans 30
W Compliance to 8.5.2 Corrective action 8.5.3 Preventive action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
T Corrective Action and Preventive Action in a Holding Company Nonconformance and Corrective Action 6
M What is Preventive Action taken as part of a Corrective Action? Nonconformance and Corrective Action 5
C The prudence of combining non-conformance reports with corrective/preventive action Nonconformance and Corrective Action 10
N Corrective and Preventive Action in 8D Problem Solving Nonconformance and Corrective Action 21
D CAPA (Corrective and Preventive Action) Flow Chart example wanted Preventive Action and Continuous Improvement 3
J Can Corrective Action be the same as Preventive Action? Nonconformance and Corrective Action 33
sagai Preventive Action vs. Corrective Action as defined by 21CFR820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
C Nonconformance, Corrective and Preventive Action Procedure(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Recommendations for criteria on creating a CAPA (Corrective and Preventive Action) ISO 13485:2016 - Medical Device Quality Management Systems 8
L How to deal with too many CARs (Corrective Action Requests), PARs (Preventive Action) Nonconformance and Corrective Action 25
N Combining both Corrective Action and Preventive action procedures into one SOP Nonconformance and Corrective Action 4
sagai Should Corrective Action be segregated from Preventive Action? ISO 13485:2016 - Medical Device Quality Management Systems 10
B Electronic Corrective/Preventive Action Report for our Customer Service Department Nonconformance and Corrective Action 9
B Corrective and Preventive Action Procedure for Customer Service Nonconformance and Corrective Action 5
Q Recover a Damaged CAPA (Corrective and Preventive Action) Project Preventive Action and Continuous Improvement 6
P FDA Part 820 Clause 820.100 Corrective and Preventive Action 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Corrective Action and Preventive Action for Operator Error (Cosmetic - Handling) Preventive Action and Continuous Improvement 15
B Questions regarding Non-Conformance, Corrective Action and Preventive Action ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E CAPA (Corrective and Preventive Action) Plan Templates Nonconformance and Corrective Action 5
M CAPA (Corrective and Preventive Action) Standards & Templates for Tier 1 Supplier IATF 16949 - Automotive Quality Systems Standard 4
kedarg6500 Horizontal Deployment of Corrective Action - is it Preventive Action? Nonconformance and Corrective Action 21
W Are CAPAs (Corrective Action Preventive Action) Input or Outputs ISO 13485:2016 - Medical Device Quality Management Systems 6
Q CAPA (Corrective Action and Preventive Action) after Correction always? Nonconformance and Corrective Action 10
Q CAPA (Corrective Action Preventive Action) NC recommended for IT, HR, ACC.? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Icy Mountain Continual Improvement, Preventive Action and Corrective Action Database Quality Tools, Improvement and Analysis 23
Q Calibration Failure - CAPA (Corrective and Preventive Action) General Measurement Device and Calibration Topics 3
P When is an issue a CAPA (Corrective and Preventive Action) request? Nonconformance and Corrective Action 6
C FDA - CAPA (Corrective Action and Preventive Action) & Complaint Database 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Suggestions for a CAPA (Corrective and Preventive Action) Software Program Quality Assurance and Compliance Software Tools and Solutions 17
Q CAPA (Corrective and Preventive Action) Guidance Needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Issue Tracking and CAPA (Corrective and Preventive Action) Management Nonconformance and Corrective Action 6
N Nonconformance and Corrective Actions vs. Preventive Action - Problem Supplier Nonconformance and Corrective Action 24
A When to take Corrective / Preventive Action and Continuous Improvements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Corrective and Preventive Action (CAPA), 820.100 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
W Corrective Action, not Preventive Action? Nonconformance and Corrective Action 10
V CAR (Corrective Action Request) vs. PAR (Preventive Action Request) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D CAPA (Corrective Preventive Action) Form for critique ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom