When is a Formal Corrective Action Necessary?

barb butrym

Quite Involved in Discussions
When is formal CA necessary?

When do you draw the line and say..OK now you've done it....I want FORMAL corrective action and I want it effective?

With industry running lean and mean, a formal CA/PA program is harder and harder to enforce (re: resourses). What are some effective 'non formal' CA/PA programs that have been successful?
Elsmar Forum Sponsor


Fully vaccinated are you?
Staff member
I see this as an issue of a
Nonconformance / Corrective Action / Preventative Action
system. They are intimately intertwined. IMHO 4.13 and 4.14 should be one issue. I see the current division as pretty 'stoopid' - division of a system into elements. That said, on with the show.

When do you do a Corrective Action in response to a Nonconformance? How far do you go?

First, lets start with a little something just to get our juices flowing on this topic. Visit the following thread from the old forum:

<a href="http://Elsmar.com/cgi-bin/archiveboard.cgi?read=953">Preventive Action vs Registrar's Definition</a>

OK. Are we appropriately hyped and ready to go? Grab your Mountain Dew or other highly caffinated beverage and let's dig in. this could take some time. Onwards, my friends!

I guess I look at this a bit differently than you do barb (Barb?). smile.gif I look for a system where there is a cascade (if you will) where the nonconformance system allows for review(s) and decisions based upon knowledge and understanding of the problem as it relates to the business as a whole.

This link is to a pdf file. It is a printout of a blank record from a database I wrote about 5 or 6 years ago for a company. I think it may serve to show what I mean by a cascade.

<a href="http://Elsmar.com/pdf_files/NC_DBASE.pdf">Blank Record from a NC/CA/PA Database</a>

The problem is there is, and can be, no precise black & white line. There is a point where some decisions are simply a matter of 'opinion' - which goes back to my 'infamous' "Can You Explain?". For a given specific incident you might say you would ask for a formal CA/PA where I might not see that need.

You say "With industry running lean and mean, a formal CA/PA program is harder and harder to enforce (re: resourses)." redface.gif

I don't accept that as relevant other than as an excuse. If someone can show me that the only realistic solution for a problem is to spend US$250,000 for new equipment when they are a small shop and their product is extruded plastic parts for a non-critical assembly (maybe eliminating flash from a wheelbarrow body) I accept that. I'd expect a problematic, but acceptable solution such as humans trimming the flash to a reasonable (however you want to define 'reasonable'...) 'degree' where some flash would get through but is 'tolerable' - it's an issue of visual appearance and not a critical issue such as a functional problem. Contrast this to say airbag igniters where there is a critical sleeve OD which, in large part, controls 'back flash' from the charge, I would expect the company to go farther. Possibly new molds. Possibly a material change. Possibly a new press. Possibly a combination. Probably a PokeYoke preventive action - whatever it takes due to the nature of the criticality of the dimension (the OD of the sleeve) and the nature of the possible effects of an out-of-dimension condition (where we get into FMEA and Control Plan issues including revision).

But back to your question. I'm not sure what you mean by 'non formal'. Do you mean not reported in any way? What is your definition of Formal?

I see the typical failure mode in NC/CA/PA systems as the link at Management Review and in other (depending upon company size - which should be considered throughout any discussion of NC/CA/PA systems) relevant meetings.

You say "...harder to enforce (re: resourses)". I say hogwash. Upper management has the option to enfore the system - or they can ignore it. BUT - I believe (IMHO) that if the system breaks down it's the fault of upper management.

I worked with one company where folks were supposed to wear certain clothing. As I walked through the plant it was obvious people were not complying to the company requirement. I spoke with the plant manager (whom was on the floor quite often) who told me he had never thought about it. He said he was well aware of the requirement but saw that as a middle and lower management issue. Yet - he never brought it up with them until after the audit pointed it out. I guess he figured 'some day' the folks below him would handle it. My very pointed question to him was was, "If you knew it was happening and you did nothing, what else is happening that you do not address?"

Moral of Story: If upper management is not involved any system can easily fail.

Bottom line: A solid NC/CA/PA system with management involvement and strong consideration during management reviews will keep Continuous Improvement going - BUT - there is no line where you can always say this needs a formal CA and this doesn't. In addition to lots of other factors, criteria can change weekly, monthly and (definitely) yearly.

Phew.. Did I confuse things here?

Some good reference threads:

http://Elsmar.com/cgi-bin/board.cgi?read=2912 Corrective Action - Closing the Loop

http://Elsmar.com/cgi-bin/board.cgi?read=2885 Corrective Actions

http://Elsmar.com/cgi-bin/board.cgi?read=2760 Preventive Action

http://Elsmar.com/cgi-bin/archiveboard.cgi?read=2615 Need for Corrective Action

http://Elsmar.com/cgi-bin/archiveboard.cgi?read=2574 Confirming Corrective Action Effectiveness

http://Elsmar.com/cgi-bin/archiveboard.cgi?read=2478 8-D Analysis

http://Elsmar.com/cgi-bin/archiveboard.cgi?read=2386 Effectiveness of Corrective/Preventative Actions

http://Elsmar.com/cgi-bin/archiveboard.cgi?read=1108 8-D Forms

http://Elsmar.com/cgi-bin/archiveboard.cgi?read=404 FMEA RPNs

[This message has been edited by Marc Smith - August 1998.]

barb butrym

Quite Involved in Discussions
Marc, I was speculating..had nothing in particular in mind, just general conversation.
By formal I was thinking of a detailed data base and the whole nine yards...by informal I was thinking of a short handy dandy unsophisticated way to capture it on the fly.

What I find so often, especially lately as the 'downsized' clients are growing back to size, the resourses are not there YET to capture all the data that is so nice to have.

For example 1 electronics company...their NC report has a place for CA, and that is working well for them. there is a tie from audits and that works well, BUT out there in the process world...they still have small grumblings of issues (not NC product) that reoccur....notices, reinforcement, retraining etc..and still some pop up again..and again...the CA isn't doing well there. Its not highly visible, just aggravating....really grates on me. They seem like small issues to anyone who is not on the receiving end, but I can't get them to do the formal CA thing, as they don't want to be seen as uncooperative or petty. I agree that the depart-manager is the reason behind that, he treats all formal CA as an invasion of his space, then reluctantly does what is needed...but his attitude is felt quite clearly in his department. As a result, since he signs the performance reviews, the workforce mirrors his feelings and does not use the CA/PA system to their advantage. It is historic, has been like that for the 20 years I have been associated with them. So I am always looking for a new approach to win them over.

They do PA well, real well....BUT don't document it well....so it looks like they do very little. I am working that with them, and it is slowly coming to fruit.

That said, what new innovative approaches are working for others out there, that use positive instead of negative vibes, and don't take alot of time to implement?


Unfortunately, until the department manager sees the value of a ca/pa system, no system will work for you. Why don't you ask him to accompany you on the next audit your registrar performs...or make sure the auditors visit his area. That way, not only will he be on the hotseat to see firsthand how important it is to follow a system come audit time, you might just get the official finding you need from your registrar to put some weight behind solving the issue once and for all.

No one has time to dream up systems that work in a vacume around difficult people. The sooner you have team cooperation, the better whatever system you choose to implement will work. A so-so system can accomplish quite a bit in an outstanding team environment. The best system around will never work in a non-cooperative one.

George Trybulski

Well, you got me now, now what to do with me. Nonconformance to Corrective Action ? When do you need to impliment Corective Action ? When an operator breaks a tap off on a part, when they drop a part and damage it, when the part comes loose in a vise. Corrective action answers: Don't tap any more parts, don't handle parts ever again, tighten the snot out of the vise. Will retraining solve the problem, and as to "is it effective" should I stand around to see if the operator is going to break another tap ? Do you need Corrective action every time someone "breaks a fingernail ? ENOUGH RAMBLING !!!!!! All nonconformities are important for it gives us data to develop trends which feeds Paredo analysis, and that is what should be your basis for Corrective action, the culimination of the trivial many to establish what your core problems really are. You would be chasing your tail if you take every one individually. The real task is when to ask yourself,"when or when not to impliment Corrective action to a singular problem". What is the "cut off point". I'm still trying to tackle that one myself for it is difficult to set a "standard" on when and when not to. Any feedback to these comments would be incouraged. Happy ISOing !


Fully vaccinated are you?
Staff member
Like I said above, each 'incident' is different and as you travel through your system there should be points where decisions are made about continuing or ending the response to the incident.

With data systems as they are now, it is easy to track even the most minor of incidents. Many companies do. With a database, reports are important - but just as important is the question of what to trend. Ford's QOS is an interesting system to look at.

Do you report every broken finger nail? Maybe - depends upon how good you are and what a broken finger nail means to your product and processes. A broken finger nail in the right circumstance could be a serious contamination problem!


I too struggle with the multitude of interpretations of what is preventive and what are corrective actions.

I believe that the difficulty comes from two different definitions of prevention.

First, which is associated with a corrective action, is the prevention from reoccurrence. If we subscribe to the 8-D philosophy or some similar problems solving method, the prevention is a natural step for an effective solution to an identified problem, thus a corrective/preventive action.

The second definition seems to be that "Prevention" means a more proactive, predictive philosophy. One registration auditor I have dealt with, stated that if a problem has occurred, the it cannot be preventive, it must be a corrective action. That interpretation leaned toward using the "Preventive Action" process as a separate entity and that a preventive action would have to be prevent a potential issue from becoming an issue. For example, if we pursued cost reductions to maintain our competitive edge, it then becomes more of a method to prevent a potential issue, that to correct something that has demonstrated that it is an issue.

Every "Corrective Action" should contain a plan to prevent reoccurrence, but does not constitute "prevention" from a predictive perspective.

Since we use a problem solving method where we identify, containment, root cause, preventive action, mistake proofing, impact/similar products and a verification section; I am considering changing our terminology from "Corrective Action System" to "Corrective/Preventive Action System".

I would appreciate you comments!


Differences Corrective Actions, NonConformances, Preventative Actions

Does anyone have a simplistic guidline for the differences between NC, CA, and PA??

I am trying to put together a VERY simple workshop on this.

Any suggestions???

Thanks Edith


Simplistic here!

You have hit my level Edith.

Nonconformance is what what went wrong - a bad part - not following a procedure - (a deviation from what is acceptable).

Corrective action is what you do to fix the nonconformance and guard against it happening again - investigation - interim action - permanent action - verification.

Preventive action is when you apply a safeguard to stop something from happening before it becomes/creates a nonconformance - installing a divider between two work areas to keep products from being mixed - adding "mistake proof" tooling to eliminate possible employee error.

For the unabridged version, take a look through some of the other threads. There are some great discussions on this topic.


This may sound a bit simplistic, but I can't get any deeper than simple! :biglaugh:

9K2K (My favorite book!) says:
"Corrective actions shall be appropriate to the effects of the noncomormitites encountered." [8.5.2]

When do CAs need to be formal? When their effects require it. Little problems need little CA, BIG problems need BIG CA. Where is the line drawn? Wherever YOU decide. If a little CA is ignored, then escalate it to a BIG CA.

If I might be permitted to quote James (JRKH):

Low tech is better than no tech.

BTW, I was told I could not say "Keep it simple, stupid" (by my employer) because I might offend stupid people. If they were truly stupid, they wouldn't understand they were insulted. So I have to say "Keep is short and simple"
Thread starter Similar threads Forum Replies Date
S Formal written response to a corrective action? Nonconformance and Corrective Action 9
L Is it required to write a formal corrective action on any nonconformance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 29
I When to start a formal corrective action as a follow-up action after audits General Auditing Discussions 11
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 21
V Manufacturing without a Formal Drawing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R MDR Software Rule 11 Formal Interpretation EU Medical Device Regulations 7
I Bench Testing & Pre-verification vs. Formal verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J When to Take Formal Action on a Supplier Supplier Quality Assurance and other Supplier Issues 7
S Forecasting and Material Planning - Are formal procedures required? Document Control Systems, Procedures, Forms and Templates 3
Q Is there a formal process for disputing a 483 for a medical device company? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Is a formal review after OQ (in Process Validation) required? Qualification and Validation (including 21 CFR Part 11) 2
A Auditor threatening Formal NC and CA for not enough PA Preventive Action and Continuous Improvement 23
M Continuous Improvement Log vs. Formal CAPA System Preventive Action and Continuous Improvement 3
N The formal definition of Domestic Environments in in CISPR 11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
W Is formal training required for Internal Auditors? Internal Auditing 7
R Auditing a process outside the realm of the formal Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A 483 Response Letter - Are there any Special Formal or Content related Requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
P Acquire formal USFDA Inspector for USFDA Inspection Preparation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M ISO TS 24971 Updates and formal objection of the European Commission to ISO 14971 ISO 14971 - Medical Device Risk Management 24
A Formal Way for Documenting Design Input Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Formal Resource Request Form example wanted Document Control Systems, Procedures, Forms and Templates 3
J Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not exist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
T TS16949 Certification withdrawn - What should be included in a formal appeal request? IATF 16949 - Automotive Quality Systems Standard 3
H Formal Quality Qualification - What qualification(s) would be the best? Professional Certifications and Degrees 10
A Difference between formal and informal Kaizen Lean in Manufacturing and Service Industries 6
A No Formal Documented Performance Evaluation for Contractual Personnel ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
J Does Management Review need to be a Formal Meeting? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
C ISO 9001:2008 Contract Review for a business that doesn't have formal contract review Contract Review Process 11
M Formal SQAM requirements interpretation training Customer and Company Specific Requirements 5
Hershal Formal complaint to Europe regarding beer..... Coffee Break and Water Cooler Discussions 43
K No Formal Design Process - Audit Finding - Help with Section 7.3 of ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
P Formal Quality Control Agreement with specific suppliers - Required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Sterile Field - Legal/formal definition US Food and Drug Administration (FDA) 4
J Formal CS1 Notification Letter Ideas and/or Template needed IATF 16949 - Automotive Quality Systems Standard 14
K Is formal Internal Auditor training required for ISO 17025:2004 - Clause 4.14.1 ISO 17025 related Discussions 5
V GAGE R&R Formal definition/ formulas for master's thesis Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R Training Needed for Registration - Is Formal ISO Training Required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
C Does a small typo in a procedure require a formal change notice? Document Control Systems, Procedures, Forms and Templates 22
E FDA - Audit - Response - Observation form 483. Do we now receive a formal letter? US Food and Drug Administration (FDA) 5
I Internal Auditor Training - Does TS 16949 Require Formal Training or Certification? Internal Auditing 19
H Placed in the position of implementing ISO 9001:2000 but have no formal training ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Sidney Vianna Official ISO Interpretations - A Formal Process for ISO9001 Interpretation Requests ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
B Can formal document control requiring QM signoff live with continuous improvement? Document Control Systems, Procedures, Forms and Templates 21
A Quality Audit Report - Report Format and some Formal Sentences General Auditing Discussions 22
CarolX Request for Formal CA - To Issue or Not to Issue Nonconformance and Corrective Action 15
Z The requirement of 'a formal training program for R&M' - 4.18 Training QS-9000 - American Automotive Manufacturers Standard 3
U QS 9000 Audit - Trainer of internal auditors not having formal training QS-9000 - American Automotive Manufacturers Standard 6

Similar threads

Top Bottom