When should a Corrective action be created? (Procedures not being followed)

S

ssz102

#11
i wondered that: even if someone contact with the supplier directly to get a quote or asked it provide goods to your company, but how are they payment to supplier? and doesn't need to via finance officer or supervisor?

so you can stipulate that all purchasing orders must be signed by buyer and that can be payment to supplier, do you think it is reasonable?
 
Elsmar Forum Sponsor

NikkiQSM

Quite Involved in Discussions
#12
hmmm..

maybe change the "Corrective action request form" to " Problem investigation request" form

then we would decide if the problem needs simple correction or corrective action

Thanks
Good idea. Review the "problems" and conduct a risk assessment on each. Ask yourself how much it will cost to fix the problem. Is it worth fixing? Maybe this is just isolated?

Get a group together - Discuss what would happen if you dont fix the problem.

Use everyone to decide what needs a CAR and what does not.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#13
It's weird to request a corrective action. People should identify NCs and request an investigation. Then, after analyzing the root cause, you decide if you need only a correction or a corrective action.
I believe that the determination of the need for a corrective action should precede the root cause analysis, which can be a time consuming, complex and costly exercise.

Root cause analysis should only be undertaken for those situations deemed critical or serious enough for a formal corrective action. For trivial, non-repetitive and non-critical nonconformities, when correction is sufficient and commensurate with the problem, I would advise against formal root cause analysis since it would be non value added.
 
Last edited:

Marcelo

Inactive Registered Visitor
#14
I believe that the determination of the need for a corrective action should precede the root cause analysis, which can be a time consuming, complex and costly exercise.
Well, that's not exactly how standards deal with it:

a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not recur
On b) you analyze the root causes, and on C) you decide if a corrective action is needed or not.
 

andreww

Involved In Discussions
#15
Well, that's not exactly how standards deal with it:



On b) you analyze the root causes, and on C) you decide if a corrective action is needed or not.
I have simliar issue in work to dealing with heaps of NC and end up with lots of CAR/SCAR. If I am going to set up a classification on NCs, non critical to just containment action, critical NC will go to CAPA process. As per ISO 9001:2008, shall I clearly define the criteria to classify which is critical NC to do CAPA, and which is non critical, only containment action/NCMR is enough? Is it mandatory to have a NC criteria in our procedure?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#16
On b) you analyze the root causes, and on C) you decide if a corrective action is needed or not.
You are correct, Marcelo, in listing the items in ISO 9001. However, the standard does not say the steps need to be done in that specific sequence. Also, when we pay close attention to the ISO 9001 text, we note that the standard does not use the term ROOT cause. Just cause(s). In the real world, we all know that EFFECTIVE (ROOT) cause analysis are rare. Most organizations out there focus on correction and very few do an effective job of investigating in depth ROOT causes, so TRUE corrective action can be enabled.

If we forget ISO 9001 for a minute, do you believe there is value in going through a (root) cause analysis for a non-repetitive, non-critical, trivial issue? In my opinion, it does not. Finally, we must realize that even standards have flaws. For example, it looks like ISO (including the TC 176) finally realized the problems with the concept of preventive action, as written, in the current ISO 9001 standard. For those who attended the ISO 9001:2015 revision webinar by Dr. Nigel Croft (chair SC2 TC 176), we heard that the next version of ISO 9001 will no longer have the requirement for PA, as currently defined.
 

Marcelo

Inactive Registered Visitor
#17
You are correct, Marcelo, in listing the items in ISO 9001. However, the standard does not say the steps need to be done in that specific sequence. Also, when we pay close attention to the ISO 9001 text, we note that the standard does not use the term ROOT cause. Just cause(s). In the real world, we all know that EFFECTIVE (ROOT) cause analysis are rare. Most organizations out there focus on correction and very few do an effective job of investigating in depth ROOT causes, so TRUE corrective action can be enabled.

If we forget ISO 9001 for a minute, do you believe there is value in going through a (root) cause analysis for a non-repetitive, non-critical, trivial issue? In my opinion, it does not. Finally, we must realize that even standards have flaws. For example, it looks like ISO (including the TC 176) finally realized the problems with the concept of preventive action, as written, in the current ISO 9001 standard. For those who attended the ISO 9001:2015 revision webinar by Dr. Nigel Croft (chair SC2 TC 176), we heard that the next version of ISO 9001 will no longer have the requirement for PA, as currently defined.
Maybe the problem here is, as always, what auditors usually expect and what the standard expect.

My opinion is that the standard does expect and analysis of the root cause - because that's exactly how the field of quality management treat NCs - as problem with process variations and analysis of the root cause of variations. And this is the value - if you don't get to the root cause, you simply really do not know what to do, or you can something that does not help at all.

Root cause analysis does not have to be complicated. it only have to look at the root cause (instead of the apparent cause).

For a critical, non-trivial issue, it's easy to get to the root cause, so I don't see any burden.

And sure, even standards have flaws. I myself am dealing with some with that have big flaws and which are very difficult to change, even with revisions.

But I don't think in this case ISO 9001 or the like have flaws. I think the problem here is expectations.

Ads you mentioned the preventive action problem, this is exactly a show of the problem with expectation. The standards itself is not really wrong, but people are interpreting it wrongly for years. The next version of ISO 9001 will try to correct it by removing the PA and requiring risk analysis on the QMS (which in practice is the same thing, but this way maybe people understand that it has to be performed in a systematically, continuous way).
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#18
The standards itself is not really wrong, but people are interpreting it wrongly for years.
Marcelo, you know that standard writers (sometimes) follow design specifications for the documents. Any standard (containing requirements) being developed has to be assessed by the writing team for clarity and auditability.

The MAJOR drive for the ISO 9001:2008 amendment was to clarify the requirements. If you remember, we have numerous (and some of the longest) threads on preventive action. One of them is the Should the TC 176 Re-word the Requirements for Preventive Action? where I wrote:
It miffs me to realize that the forthcoming revision of ISO 9001, designed and intended to CLARIFY the requirements of the standard, proposes NOT a SINGLE clarification other than

e) reviewing the effectiveness of the preventive action taken.

Why in the World the TC 176 fails to realize that preventive action needs clarification leads me to believe that, as I said before, they are out of touch with "ordinary people and systems" or realized they are powerless to come up with a better text.
So and, in my opinion, a standard that allows itself to create so much confusion and lack clarity on the conformity assessment piece has flaws. It was not adequately validated against the Design Specification, or other inputs.
 
#19
Hello To All .

I am having a problem at work .

Corrective actions are being requested for the following:

- Customer complaints
- Internal audits
- Product Non Conformance
- Issues costing the company Money
- Procedures not being followed

my main concern is the 5th point ... its creating a lot of problems because people are feeling like other people are "snitches" and they are getting angry at each other when some people are reporting that a procedure was not followed

MY question is : How can i clarify to the staff when it is OK to request a Corrective action , and when a corrective action is not needed ( a simple correction will do ) ???

Could you provide me with examples of "levels" of corrective actions , or any classification that would allow me to determine if a corrective action needs to be created ?

Thanks for the help
Are you saying that anyone can create a CAR because they see others no following procedures? If so, stop that practice straight away!

You may wish to look at your internal audit program to discover why the internal auditors haven't been discovering this! If it's so obvious, then an internal audit should be directed to determine what's going on. They can take the subjectivity out of the situation.

WARNING! If your internal auditors also find the same symptom, they also need to go one step further and determine what is the effect on process and product of someone not following the procedure. After all, it may have no effect, and the procedure might need fixing! Maybe the procedure isn't needed and people resent them!

Finding out why people don't follow documents is of importance - and be prepared for an answer you won't like! It may mean that the documents are useless, can't be followed or aren't user friendly! Also, ask yourself why your internal audit didn't find this, too! They should have!:mg:
 

Ragnarok

Involved In Discussions
#20
Re: When should a Corrective action be created ?

Excuse me ?

How can the internal audit discover the problem if the problem did not exist when the Internal audit was performed??

Please reread the description of the problem below

yes documented procedure

i will give an example:

Our Purchasing procedure stipulate that our purchasing officers must get quotes and contact the suppliers to get prices and purchase goods .

However there are some employees (not purchasing) that contacted directly the supplier , got a quote and then asked the supplier to send us the goods

This infuriated the purchasing officers who sent a corrective action request , but it created a problem between purchasing department and other departments

The persons that contacted the suppliers said that they did it because it was an emergency ...but our procedure does not allow other people than purchase officers to buy from suppliers even if its an emergency :(

hope I am clear

Kindly advise
And Yes , Anyone was able to request a corrective action request before ,which does NOT mean it was always approved

The request was analysed and a corrective action was performed or not

Kindly advise whats wrong with what we are doing ???
 
Thread starter Similar threads Forum Replies Date
sagai Should Corrective Action be segregated from Preventive Action? ISO 13485:2016 - Medical Device Quality Management Systems 10
A Whom should I send the FSCA (Field Safety Corrective Action) to? EU Medical Device Regulations 2
C Should Preventative Action follow a Corrective Action Nonconformance and Corrective Action 27
J What should generate a CAPA (corrective action - preventive action) US Food and Drug Administration (FDA) 16
Q How many records should I keep when implementing Corrective Actions Records and Data - Quality, Legal and Other Evidence 3
Q CAPA - What criteria should be used to initiate Corrective and Preventive Actions ISO 13485:2016 - Medical Device Quality Management Systems 8
T Who should take the lead for 8D Corrective Actions Preventive Action and Continuous Improvement 13
S Who should do the CA's (Corrective Actions) from Internal Audits Internal Auditing 9
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26
D Class II medical device - When should a complaint be closed? Customer Complaints 6
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom