Identifying Response Times for CAPAs (Corrective and Preventive Actions)

C

claire_deen

#1
Hi guys,

I am working on a dissertation at the moment, studying quality management (WHY WHY) ha ha.

Anyway the standard I am working on is API Q1 and it asks that the organisation shall identify response times for addressing corrective action, preventive action and nonconformances.

I'm a bit stuck at how this is worded. The company does have a form for each of these where it has a section for proposed timetable for preventive and corrective actions. In the form for nonconformances it asks for implementation details for any rework etc.

Can anyone shed any light on this?

Thanks again,

Claire:)
 
Elsmar Forum Sponsor
T

tomvehoski

#2
You can set a timetable for milestones within CAPA, but setting one for overall closure is a bad idea. Every problem is different, so some may be able to be closed in a day. Others may take weeks, months or years.

For example, 24 or 48 hours is often set as a requirement for containment of a CA. This means you need to have the problem identified and have a short term plan to keep production (or whatever) running. Basically it means stopping the bleeding, but not performing the diagnosis or surgery.

From there, I prefer to set milestone dates for each CA instead of a blanket "must be complete in 30 days". If root cause analysis requires getting parts back from customers, sending stuff for outside testing, etc. it may take a long time. I format it as:


Permanent CA can take even longer. I had one that remained open for over a year. The action was to replace a piece of capital equipment. It took that long for the capital expenditure approval, design, build, ship, install and try out of the machine. I refused to close the CA until I saw the new machine run, since I could not otherwise verify the effectiveness of the CA. Every 30 or 60 days I required the CA owner to give me an update and extended the "due" date, but it remained open.

My CA form requires dates for each action, not just overall closure. Such as:

Action - Owner - Due
1. Design new machine - Bob - 9/1/2010
2. Build new machine - Bill - 12/1/2010
3. Installation - Mary - 12/15/2010
4. Tryout - Bob - 1/15/2010

Each once becomes a mini-project. Note this is only for complicated problems, not for the simple stuff.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
You can set a timetable for milestones within CAPA, but setting one for overall closure is a bad idea. Every problem is different, so some may be able to be closed in a day. Others may take weeks, months or years.

For example, 24 or 48 hours is often set as a requirement for containment of a CA. This means you need to have the problem identified and have a short term plan to keep production (or whatever) running. Basically it means stopping the bleeding, but not performing the diagnosis or surgery.

From there, I prefer to set milestone dates for each CA instead of a blanket "must be complete in 30 days". If root cause analysis requires getting parts back from customers, sending stuff for outside testing, etc. it may take a long time. I format it as:

Permanent CA can take even longer. I had one that remained open for over a year. The action was to replace a piece of capital equipment. It took that long for the capital expenditure approval, design, build, ship, install and try out of the machine. I refused to close the CA until I saw the new machine run, since I could not otherwise verify the effectiveness of the CA. Every 30 or 60 days I required the CA owner to give me an update and extended the "due" date, but it remained open. <snip>
As I was reading some old threads here on corrective action response times, I felt that this response was so good that I decided to "bump" it.

Too many people think too short term and idealistically. Every non-conformance is different.
 
Thread starter Similar threads Forum Replies Date
M Identifying Applied Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
DuncanGibbons Best practice for identifying "items" of parts for DFMEA analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Identifying Technologies for Non Destructive Examination of steel brazed joints Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
R Identifying internal issues.. at what level? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D Identifying externally provided services referenced by IATF16949 IATF 16949 - Automotive Quality Systems Standard 2
Marc ISO 9001:2015 - Identifying interested parties, or stakeholders ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Identifying AS9100 for a Legacy Product Manufacturing and Related Processes 11
H Identifying Guidance on Medical Device Software Level of Concern for the EU EU Medical Device Regulations 2
S Identifying Objectives & Targets for Quality Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J API Q1 5.6.1.2 (iii) Identifying how the supplied product conforms Oil and Gas Industry Standards and Regulations 1
A Identifying context for every process in an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
T "Indication for Use" Identifying Specific Procedures US Food and Drug Administration (FDA) 2
LRE67 Need help identifying this "thing" Coffee Break and Water Cooler Discussions 9
Y Identifying lighting requirements for in house Calibrations General Measurement Device and Calibration Topics 8
A Identifying and Tracking Customer Specific Requirements Customer and Company Specific Requirements 1
P Identifying Medical Device Class and Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Identifying gaps over ISO 13485 to be compliant to MDD 93/42/EEC requirements EU Medical Device Regulations 5
A Please suggest analysis for identifying the warranty Reliability Analysis - Predictions, Testing and Standards 1
P Renault CSR - Identifying the difference between an ASES and ASAS-P Audit IATF 16949 - Automotive Quality Systems Standard 4
Q Identifying Critical Items and Key Characteristics - Product Realization Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Procedure for Maintaining Industry Standards and Identifying Revisions Document Control Systems, Procedures, Forms and Templates 1
S Identifying Processes in a Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Risk Factors Checklist identifying the Risks for meeting the Customer Indent AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Identifying version of Standards in Functional Specification of a New Device ISO 13485:2016 - Medical Device Quality Management Systems 6
K Identifying Required Testing to comply with IEC 60601 EU Medical Device Regulations 4
C Document Control and Identifying Distribution ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
H Identifying Potential Automotive Suppliers before Developing New Products Supplier Quality Assurance and other Supplier Issues 2
R Identifying procedures that are NOT required by ISO 9001 Quality Manager and Management Related Issues 17
N Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements Document Control Systems, Procedures, Forms and Templates 13
J Help in identifying Legal and other requirements for Indian localisation Miscellaneous Environmental Standards and EMS Related Discussions 4
A Audit NC - Not identifying our Customer Specific Requirements - TS16949 (7.3.6.3) General Auditing Discussions 7
8 Introducing a Balance Line - Identifying potential future pitfalls etc. Lean in Manufacturing and Service Industries 2
V Identifying Significant Factors - Regression Analysis vs Correlation vs ANOVA vs DOE Quality Tools, Improvement and Analysis 7
F Requesting Help in Identifying Ford Suppliers Supplier Quality Assurance and other Supplier Issues 6
A Document Control File - Identifying all documents which need to be controlled Document Control Systems, Procedures, Forms and Templates 11
A Identifying the Clean Room Requirements for a Medical Device in US and EU ISO 13485:2016 - Medical Device Quality Management Systems 3
M Identifying Routine and Non-Routine Activities: OSHA OHSAS 18001 Occupational Health & Safety Management Standards 6
E Developing the Essential Requirements Checklist - Identifying Requirements Other US Medical Device Regulations 3
E Identifying the Elements of Informed Consent expected by the IRB and FDA Other US Medical Device Regulations 4
F Identifying Calibration on Small Tools (Measurement Equipment) General Measurement Device and Calibration Topics 2
J Need help identifying nonconformities in internal audits Internal Auditing 2
A Identifying trends in QMS Nonconformities Quality Manager and Management Related Issues 1
B Looking for a Standard identifying SME's (Standard Measuring Equipment) General Measurement Device and Calibration Topics 1
C CB Client Contract Agreement - Identifying nonconformances - AS9100 Registrars and Notified Bodies 7
M Identifying Rework in Maintenance or Craftsman Operations Lean in Manufacturing and Service Industries 12
R Identifying "or equivalent" Test Equipment when written in a Procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
N Sheet Metal Identification Ideas - Best Practices for Identifying Raw Material Document Control Systems, Procedures, Forms and Templates 8

Similar threads

Top Bottom