Is a separate Corrective & Preventive Action procedure necessary?

C

Christine Pearce

#1
Hello to all from a newcomer to ISO and the list.

ISO 9001:2000 Clause 8.5.2 states we must have documented Preventive (PA) and Corrective Action (CA) procedures. Does this necessarily mean they have to be separate from our other process procedures?

I ask because, when I start to write the PA and CR procedure (we've decided to combine them), I find we're duplicating everything that is in the individual procedures for every process we've got. With over 20 processes within the company, each with different forms, methods, reviewers, etc - it would be a nightmare to ensure they correlate correctly.

If a separate PA and CR procedure is necessary, can't we just, for example, have a flowchart that says "Identify nonconformance - document it - investigate it - fix it" with a corresponding flow for looking at data for PA, flowing it to our Continual Improvement Board, then to Management Review?

Many thanks,
Christine
 
Elsmar Forum Sponsor

Russ

Quite Involved in Discussions
#2
Christine Pearce said:
Hello to all from a newcomer to ISO and the list.

ISO 9001:2000 Clause 8.5.2 states we must have documented Preventive (PA) and Corrective Action (CA) procedures. Does this necessarily mean they have to be separate from our other process procedures?

I ask because, when I start to write the PA and CR procedure (we've decided to combine them), I find we're duplicating everything that is in the individual procedures for every process we've got. With over 20 processes within the company, each with different forms, methods, reviewers, etc - it would be a nightmare to ensure they correlate correctly.

If a separate PA and CR procedure is necessary, can't we just, for example, have a flowchart that says "Identify nonconformance - document it - investigate it - fix it" with a corresponding flow for looking at data for PA, flowing it to our Continual Improvement Board, then to Management Review?

Many thanks,
Christine
Yes you can combine the two. We currently have seperate procedures, however we are probably going to combine them within the next year.
 
C

Christine Pearce

#5
Thanks for responding, Russ and Bill.

I have read everything in the CAPA forum, but I still don't know if a separate procedure really necessary", since all our procedures already have their instructions for carrying out CA & PA action, with associated records.

BTW... We don't have a separate Continual Improvement procedure, but cover all the inputs to the process and its outputs (such as PA & CA) in a flowchart in our quality manual, which then links to Management Review, back to processes, and so on in a loop.

Christine
 

Geoff Cotton

Quite Involved in Discussions
#6
Christine,

We have two procedures. However, because they are computer network and hyperlinked to each other to the end user they apear as one when they enter the business management system.

If you want to come over and take a look give me a call, your more than welcome.
 
C

C Emmons

#7
We have one procedure, but the are addressed seperately within the procedure itself. No problems during my audits with having them combined. :)
 
J

Jimmy Olson

#8
We have one procedure and one form to cover CAPA and have been through several audits without any problems.

We also combined our document control and record control into one procedure, but that's a seperate thread.:p

Basically you can design your procedures however you choose as long as you address the basic requirements.

By the way, welcome to the cove :bigwave:
 
C

cleverfox

#10
Hello and welcome Christine,

We have two procedures. My preventive action procedure basically is a declaration that we take proactive measures rather than reactive, and we accomplish that through the utilization of SPC charting where we avoid unacceptable conditions prior to them going out or trending out.

Also states that we use APQP and FMEA which are tools to identify potential problems "before" they can occur.

Our corrective action procedure is basically a flow chart of our 8D system.

It is pretty easy. But my opinion (for whatever it is worth) is that you should handle these two things seperately.

Sincerely,
Fox
 
Thread starter Similar threads Forum Replies Date
R CAPA (Corrective Action Preventive Action) Procedures Separate or Combined Nonconformance and Corrective Action 9
A Are two separate procedures required for Corrective action and preventive actions Document Control Systems, Procedures, Forms and Templates 38
S Preventive and Corrective Procedures - Separate Procedures? Special Procedures? Nonconformance and Corrective Action 8
Marc Corrective vs. Preventive Systems and Procedures - Separate Procedures? Nonconformance and Corrective Action 12
Q Corrective Action as a Separate Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 4
I Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
CPhelan Internal audit - Combine similar nonconformities in one or keep separate? Internal Auditing 6
S "X-MR charts do not separate piece-to-piece repeatability of the process" Statistical Analysis Tools, Techniques and SPC 2
R How far apart can you schedule separate areas or departments in your internal audit? Internal Auditing 4
S Do we need separate stand alone procedure for Suspect Unapproved Parts? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
J Facilities - Placing our assembly group into a separate building ISO 13485:2016 - Medical Device Quality Management Systems 8
W Product Audit - It must be a separate and distinct activity (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 4
C ISO 14001 vs Existing Quality System - How to keep them separate? ISO 14001:2015 Specific Discussions 3
T Should Testing be a separate operation in the Control Plan? FMEA and Control Plans 5
P Two separate 510k submissions for one device from the same company Other US Medical Device Regulations 10
B ISO 9001:2015 8.4 External Providers - If work is transferred to a separate facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Is a separate ISO/TS16949 certificate required for an extension site? IATF 16949 - Automotive Quality Systems Standard 4
T Two Separate Businesses - Only Part of Company Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Separate Classifications for Medical Device Accessories EU Medical Device Regulations 2
R One-Time parts separate from QMS? Quality Manager and Management Related Issues 9
D Is a separate spreadsheet required for the ASL (Approved Supplier List)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Connection to a generic separate power supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Regulations for Selling Convenience Kit vs. Selling Separate Parts Other US Medical Device Regulations 2
cscalise Separate Forms or Procedure Attachments - What's more common? Document Control Systems, Procedures, Forms and Templates 2
C Do separate sites need separate documents? Document Control Systems, Procedures, Forms and Templates 7
A Newly Incorporated Business - Separate Scope and/or Separate Cert? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L Should Internal Audit CAPAs be kept separate from "normal" CAPAs? ISO 13485:2016 - Medical Device Quality Management Systems 6
P Separate procedures? ISO 14k System combined with OHSAS 18001 Occupational Health & Safety Management Standards 3
J Device Registration and Listing - Separate for Device and corresponding Instruments? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Two Separate Legal Entities - Manufacturer Vs. Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
Q Separate Quality System? Product line of a parent company spins off 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
C What can you do if Quality is treated as a separate function in an organization? Quality Manager and Management Related Issues 24
C Separate Certification - Can I combine documents for ISO14001, OHSAS18001 & AS4801? Miscellaneous Environmental Standards and EMS Related Discussions 3
S IEC 62366 - Embedded Software in separate Usability Engineering File? IEC 62366 - Medical Device Usability Engineering 1
K How do ISO 9001 Requirements apply to 2 sets of specifications to 2 separate vendors? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Include as an attachment or make a separate document? Advise on Document Numbering Document Control Systems, Procedures, Forms and Templates 1
F Multiple Business Lines (Separate Corporations) in one Facility AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
B Separate Clinical Trials in the US and the EU - When one fails - question US Food and Drug Administration (FDA) 3
M Can I be a legal manufacturer without being a separate legal entity? CE Marking (Conformité Européene) / CB Scheme 6
B Hospital Operating Room Regulations - Separate Entrances for Clean and Dirty Supplies Hospitals, Clinics & other Health Care Providers 4
SteveK Separate Medical Device 12V Power Source - What inspection and testing is required? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedures ISO 17025 related Discussions 4
R HVAC Contaminant Test for Two Separate Areas Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
R CNC OTS Software Validation Separate from full IQ/OQ/PQ for 21CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9

Similar threads

Top Bottom