Becky's Effective Corrective Action System

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
I liked this message from Becky R. with one comment: I see much of the problem in the failure of folks to understand the 8-D system, or at least it's underpinnings from a Prevent Recurrence (Continuous Improvement) standpoint. Even in companies I see keeping up with corective actions I see root causes such as:

Won’t work, no power, machine down, broken tool, head froze up, contaminated, rough surface, porosity, shortage of parts, rattles, quality problem, worn out, line stopped, not to specification, labour problem, management problem, too much variation, etc.

These are not root causes. Even if you can 'keep up with them' (corrective action requests), seldom are they effective in the sense of Continuous Improvement. Few folks really understand how to effectively do a Corrective Action.

Now - on to Becky:

-----snippo-----

Subject: Re: Q: Effective Corrective Action/Hitchcock/Rezac
Date: Mon, 30 Nov 1998 09:07:43 -0600
From: ISO Standards Discussion

From: Becky Rezac
Subject: RE: Q: Effective Corrective Action/Hitchcock/Rezac

Al-

The CAR system in the company I consult with has evolved over the past
several years, and has, I believe, addressed and "grown past" the
problems you bring up. They are a large company with a full-time CAR
Administrator, but there is no reason that the same concepts can be
scaled down to smaller organizations. Of course, it does take support
from upper management.

Our CARs go through several stages-
1. Initiation-CARs can be written by ANYONE. We happen to have several corrective-action, customer-satisfaction systems in place that are administered by specific organizations, but we have let it be known that CARs are for documenting any problem. Many CARs are documented during audits, but several are generated by simple observation, or to correct what anyone perceives to be a problem. Our CARs can now (recent accomplishment) be initiated over our Intranet, and are to be used by all company sites and regional offices.

2. Assignment-our CAR Administrator assigns a CAR number (actually this is currently being done automatically via the CAR database), and assigns CARs to applicable departments, although he/she may have to contact the Initiator to get more information to make the assignment properly. The Department Manager is sent an email message with the CAR form attached as an RTF file-the Initiator copied. There isn't any filtering being done because there is no need-users know that problems such as "floor is wet", "bathroom lacks supplies", or "I'm not getting my email", etc., are to be called in to our Help Desk instead. To my knowledge the vast majority of CARs initiated are proper and valid.

3. Department First Response-the assigned Department has 2 weeks to respond to the CAR. The response consists of an explanation of what is the "immediate fix" (if necessary), an explanation of any other departments that may need to take action to resolve the CAR, an "owner"-who this CAR is assigned to, and a proposed "fix" date-when they think they will be able to have the problem solved. All of this information is added to the RTF file and sent back to the CAR Administrator. By the way, the Department is "reminded" just before the "Response Due Date", and if they have NOT responded within 5 days after, a message is sent to one level higher. (We used to give the departments 5 working days to respond, but 2 weeks seems to work better and be more reasonable.)

4. Extension Request (if needed)-if the department determines that it cannot meet it's initial proposed "fix" date, it may request an extension. We used to have no rules on this, but currently are allowing only one extension-after all, the department sets the proposed "fix" date itself. The Manager has to approve the extension request.

5. Ready to Close-when the department has implemented whatever changes are necessary, they send back the RTF file with information on the root cause, corrective action taken, preventive action taken, and a list of documents affected by the CAR. (All applicable fields are completed.) If this information has not been submitted before the "proposed fix date", the CAR Administrator sends a reminder. If 5 days after the proposed date either the "ready to close" response or an "extension request" is not received, a message is sent to one level higher.

6. Closure-CARs are not closed until the Initiator says that the actions taken are effective. Any documentation that required updating as a result of the CAR must be updated, released and available before the CAR can close. If the CAR describes something such as a change to an event, that event must have happened so that the changes are apparent, if practical. (We do not keep CARs open several months waiting for events.)

With regards to escalation, as I said, 5 days after a response was due-either the "Department First Response" or the "Ready to Close" information, a message is sent to Management one level higher. Five days later, if necessary, a message is sent one level higher. This repeats until a message is sent to the VP of Quality/Customer Service and the VP of whatever organization was assigned the CAR. Luckily, since we do have the support, this has not happened lately-our CAR system is taken seriously. (A few unlucky souls learned the hard way, but by now everyone has gotten the message!)

When we are receiving repetitive audit findings such as you described below, it is up to the Initiator to make the determination that the fix is not effective. Some of our CAR Initiators are easier than others, but I know that as a CAR Initiator myself I have several times not allowed a CAR to be closed when the department thinks that it has effectively fixed the problem.

--Becky
 
Elsmar Forum Sponsor

Nadaabo

Starting to get Involved
#2
This is a wonderful idea. It really does need manager support though! What if the Managers are the ones who need to respond and have no time and the GM needs their support on other projects so the CARs are not a priority? How would I deal with this situation? Right now, every CAR is being driven by just me. If I work on another project the CARs will fall through :(
I hate writing CARs because I know that by writing them I'm adding to my own workload. Any advise on how I can infuse the corrective action process into our teams?
Again, thank you so much for this post:)
 
Q

QAMTY

#3
Really, it is hard to convince people to raise NCR´s, to carry out CA/PA, to do activities which can lead to improvements, most of them see this as wasted time,

Any idea about methods to improve this practices?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Really, it is hard to convince people to raise NCR´s, to carry out CA/PA, to do activities which can lead to improvements, most of them see this as wasted time,

Any idea about methods to improve this practices?
Give it a new name. Call it something besides CAPA. Maybe Business Process Improvement (BPI) and do return on investment analysis to find the $$ value in time saved, product saved, fewer complaints, etc.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
My biggest reply is" we do not have time!!!" but we make time to rework all of it:mad:
All you can do is use a quality cost calculator add up that time - which is also taking up machine time and probably some co0nsumables - and compare it to the time to do continual improvement/preventive action. Juran had at one point said cost of poor quality was as much as 20% of sales. When the time is right (when management complains of high costs of doing business), you can produce the data and say "I have an idea."
 
Thread starter Similar threads Forum Replies Date
S Effective nonconforming process for AS9100 8.7 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
N Validation procedure, Major NC CAP - Equipment Validation process is not effective ISO 13485:2016 - Medical Device Quality Management Systems 5
A Cost effective thread gaging with ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Root cause analysis - The system of developing a work instruction is not effective Problem Solving, Root Cause Fault and Failure Analysis 1
T Effective Date on Documents 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
qualprod Effective Auditing advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q Simple and effective way to maintain Training Matrix ISO 13485:2016 - Medical Device Quality Management Systems 16
J If Corrective and Preventive Action were truly Effective IATF 16949 - Automotive Quality Systems Standard 3
qualprod Risk closeout , mitigation was not effective, next? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J Specific Actions where Timely and/or Effective Actions are not Achieved Nonconformance and Corrective Action 6
Q Predating Document Effective Date Other Medical Device and Orthopedic Related Topics 18
P Thai FDA postpone AMDD to be effective in 2020 Other Medical Device Regulations World-Wide 1
S Sell a Non-RoHS device, manufactured before RoHs regulations became effective? EU Medical Device Regulations 2
J What does "effective implementation of quality management system" mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N What does an effective design process look like? (shoots flare in the air) Design and Development of Products and Processes 2
M Corrective Action - For a corrective action to be effective, a change is required? Nonconformance and Corrective Action 5
R 5.4.1 Quality Objectives - Nonconformity: The process was not fully effective ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
R Training to Effective Documents - Transitioning to Agile Document Control Systems, Procedures, Forms and Templates 5
R Good Supply Practices that will be effective on March 1 2015 in China China Medical Device Regulations 2
Keith Childers IATF has posted new GM Customer Specifics, effective January 2015 Customer and Company Specific Requirements 5
B Medical Device Labeling - Order No. 6 Effective Oct 01, 2014 China Medical Device Regulations 7
R CFDA updated five regulations to be effective from October 1, 2014 China Medical Device Regulations 16
T Qualification System of Internal Auditors is not Effective General Auditing Discussions 5
A A Guide to Effective Internal Management System Audits Book, Video, Blog and Web Site Reviews and Recommendations 2
D Effective Date of updated SOP Document Control Systems, Procedures, Forms and Templates 3
A Effective Date (of Documents) issue outlined in 21 CFR Part 820.4 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
P Effective way for DC/DC conversion for 2 MOPP @ 250VAC IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Want best and effective solution for mouth infection Coffee Break and Water Cooler Discussions 11
S New FAA Form 8130-3 Effective 2/1/14 - Unlocked version attached Federal Aviation Administration (FAA) Standards and Requirements 3
P Effective Road Usage Coffee Break and Water Cooler Discussions 9
H How to make the Design Review Process Effective Design and Development of Products and Processes 1
Q Effective 1st Piece Inspection Sign Off Procedure Quality Manager and Management Related Issues 8
QMMike What is the most cost effective SPC software Statistical Analysis Tools, Techniques and SPC 5
Y Delivering an effective and all inclusive EHS program in a Food company Food Safety - ISO 22000, HACCP (21 CFR 120) 2
F Suggestions for quick & effective solution for Continuous Improvement Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
T Very effective movie about clean-up - Tool for 5S Training Lean in Manufacturing and Service Industries 4
M AS 9100 4.2.4 Process for making changes to records is not fully effective Quality Manager and Management Related Issues 4
Q Process Approach & Continual Improvement Clauses and Evidence of its Effective Use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M 8.2.2 Internal Audit - Determination of Effective Implementation IATF 16949 - Automotive Quality Systems Standard 4
L Audit NC - Lack of Effective Corrective Action Process ISO 13485:2016 - Medical Device Quality Management Systems 4
P Which Root Cause Analysis Method is the most Effective? Quality Tools, Improvement and Analysis 16
J Cost Effective Solution for Isolating USB 5V 500mA Power IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Q Are ECO's closed after they are shown to be Effective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
V What are the Steps in Ensuring a Definition/Implementation of an Effective Procedure Document Control Systems, Procedures, Forms and Templates 3
P What is Effective Maintenance? Auditing a Maintenance Department Manufacturing and Related Processes 5
K Minimum Requirements for Effective Document Control Document Control Systems, Procedures, Forms and Templates 2
V Biggest bottleneck/hurdle in Implementation of Effective Design FMEA FMEA and Control Plans 4
ScottK When do you make your new or changed documents effective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
V 10 Characteristics of Effective Quality Management Systems Misc. Quality Assurance and Business Systems Related Topics 2

Similar threads

Top Bottom