When to Close a Corrective Action Report?

SteelMaiden

Super Moderator
Super Moderator
#21
He said "final corrective action report," which suggests that the CA has been closed.
Not in my experience. A customer issues a (s)car to us, they want to know that we've identified a root cause and we have a plan to eliminate recurrence. Once in a great while, if it is a high impact to them, they may ask for follow-ups until all items that matter to them are complete. We do the same when we issue scars to suppliers. Depending on how much we were impacted, we may follow up on individual items, or we may accept their plan "in progress". Maybe it is just the industry, maybe we are just lucky, but for us the final report is a root cause analysis and an action plan.
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Staff member
Super Moderator
#22
20 days (or less) to close a SCAR? The customer may always be right - but that doesn't mean they are smart. or as Randy says: they're boneheads!

I guess if all the Custoemr cares about in a SCAR is that containment and any necessarry remedial action are complete in 20 or less days, then I can agree. (not all corrective actions have to get to root cause after all) In fact wehn confronted with similar situations from Customers I have always sked for clarification of expectations for closure. in every instance they have come back and said containment and/or remedial action only to close the SCAR wehn a short time frame was given. Those who wanted full root cause corrective action and implementation allowed for longer time frames but usually had interim milestones...If anyone has experienced differently - well I'm sorry; your Customer's an idiot...

I've always written my CA procedure to allow closure only upon verified implementation. Then I had a validation period with a specific assigned date listed in the CAR and in teh internal audit schedule for follow up to validate that the change is still in place and is effective - if not the CAR was reopened. (we do this for our six sigma and our lean programs as well in various forms)
 
J

JohnM

#23
There are several steps in CAR's.

1 stop the bleeding, implement quick action to prevent more non-conformities

2 do damage assessment/damage control on any past product potentially affected

3 identify root cause of the problem

3 create a plan that addresses the root cause

4 implement the plan

5 assess the effectivity of the corrective acion

Every CAR has its own scope based on what is involved in the problem and its solution. Likewise it will have its own timeline. If you write your SOP to recognize this fact and show that you are closing the easy CAR's in a reasonable time frame and are making progress on the large scope CAR's, your auditor should have no problem.

Good luck.

John
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#24
Every CAR has its own scope based on what is involved in the problem and its solution. Likewise it will have its own timeline. If you write your SOP to recognize this fact and show that you are closing the easy CAR's in a reasonable time frame and are making progress on the large scope CAR's, your auditor should have no problem.
Amen! Pearl of wisdom.
 
M

MikeL

#25
Didn't we fix this last year?

The verification is the key to an effective CAR system.

The verification is best done by an audit (objective, impartial).

So if the corrective action includes changing the process, rewriting the SOP, sticking it on the wall and having a toolbox meeting to make sure all staff are aware then the verifier has to make sure all of these things have been done and that they are effective.

To often CARs are closed out by the same person responsible for the corrective action, prematurely and without finalising the permanent fix.
 
M

MikeL

#26
20 days (or less) to close a SCAR? The customer may always be right - but that doesn't mean they are smart. or as Randy says: they're boneheads!
The sad thing is that the customer is often the root cause of the problem.

I can remember our (nameless OE) customer's SQA indignantly throwing burnt warning labels onto the meeting table and we calmly explaining that under-bonnet temperatures were well in excess of design and we had told their engineers months ago.

Try getting that fixed in 20 days!
 
K

kcoryell

#28
Thanks for all the replies on this one. Now I am going to throw a twist into the mix. We are being Audited. We have a key measureable that we will meet sales and on time delivery. When we did not meet these in October, our Management reviewed the situation and initiated a CAR. We (the team) have met and started our 8D process. We, through brainstorming, data collection, etc. developed three reasons for our root cause. Manning, scheduling, and material, we have a customer that will only firm up our orders for four weeks out and suppliers that have a 16 week lead time. This is a given evil, so we have to work around this. Anyway, we have now taken our CAR team and divided into these three categories, that will meet and come up with plans for these root causes. These teams will come back together and put together the big plan for the CAR so that we can implement and measure. Here is my dilema, my auditor is telling me that since I came up with three root causes and did this divide, even though we are coming back together, that I am supposed to close that CAR and have the teams open up CAR's. This kind of sounds like we are chasing our tails at this point. PLEASE ADVISE. RANDY, I would really like your help on this one.
 
A

andygr

#29
I would remind the auditor that the responsability for these actions lies with you and not him. His sugestions are allways appreciated but you must work with in your companys structure and culture to be sucessfull. A polite buzz off

Issueing CAR's for CAR's is pointless. Very rarely is a single sole sourch the true root of a problem. Effective solutions require coordination of actions across various functional gorups and they need to talk to make sure that they are not shooting each other in the foot.

Every day I look up at the side of the building to see what name is there. God help those folks with the this is they way we have always done it, your problem is not my problem, ship it, problems are quality issues and you found it you fix it views when I see my name on the building because there will be some POSITIVE corrective actions that day!
 

Randy

Super Moderator
#30
Change the measurable to reflect what you now believe is achievable based on your analysis. It's your objective, maybe you're trying to take too big of a bite out of the elephant. Don't soft soap it, make it reasonable but achievable.
 
Thread starter Similar threads Forum Replies Date
S How to Politely Close out a Nuisance Customer Corrective Action? Nonconformance and Corrective Action 11
S Corrective Action Audit Form to close a CAR Document Control Systems, Procedures, Forms and Templates 6
S Corrective Action and Reporting using a High-Low-Close chart in Excel Nonconformance and Corrective Action 2
P Can the Auditor close down the Corrective Actions? Internal Auditing 12
A To CAPA or not to CAPA? Requirement to close our Corrective Actions before Audit? Nonconformance and Corrective Action 8
J Mechanical inspection techniques of close tolerance parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
I What kind of wine best complements the Friday that you close out your external audit findings? Opinions are welcome. Coffee Break and Water Cooler Discussions 12
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G Timing allowed by IATF to close a Remote Site Minor Nonconformance IATF 16949 - Automotive Quality Systems Standard 2
M Informational FDA Preps for Device Shortages as Another Sterilization Facility Will Close Medical Device and FDA Regulations and Standards News 0
S FDA Inspections and Pest Control - Pallets too close to walls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
S When a deviation is opened but what does it mean to close a deviation? Misc. Quality Assurance and Business Systems Related Topics 1
E Best Ways to Close a Project APQP and PPAP 3
Proud Liberal How long does your company take to close an 8D on average? Problem Solving, Root Cause Fault and Failure Analysis 12
S Why is it so hard to close out the CAPAs ? Nonconformance and Corrective Action 16
J KPI for time to close NCs (Nonconformances) Quality Manager and Management Related Issues 17
J European Laboratories which can do IEC/EN 60601-2-50 Testing? (Close to Turkey) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Drilling Close Tolerance Holes - Advice needed on Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
Q How to close the circle QMS and ECO (Engineering Change Order)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Can I close a Complaint with only a Remedial Action? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A How long does it take US FDA to issue a Warning Letter Close Out Letter Other US Medical Device Regulations 2
T TS 16949 Major CA Close Out Visit - What can the auditor look at? IATF 16949 - Automotive Quality Systems Standard 4
M Health Canada Device Classification - Close-off clip for use with a tubing set Canada Medical Device Regulations 9
K Never been this close to a plane crash... Coffee Break and Water Cooler Discussions 38
T Training in or close to Toronto - Root Cause Analysis, Value Stream Mapping, SPC Problem Solving, Root Cause Fault and Failure Analysis 0
J Close relationships with customers? Philosophy, Gurus, Innovation and Evolution 6
R Valid Date to Close Internal Audit Non-conformance Internal Auditing 1
Marc Delphi to close, sell most plants under deal World News 0
Marc DaimlerChrysler Plans to Cut 10,000 Jobs, Close Plants World News 4
Wes Bucey Aren't we a little old to believe in fairy tales? Whirlpool to close Maytag plants World News 13
Marc RadioShack to close up to 700 stores World News 8
C How long should you have to close out a major TS 16949 audit finding? IATF 16949 - Automotive Quality Systems Standard 9
S Gage pin clearance on close tolerance - Hole size is ?.8746 ? .0001 General Measurement Device and Calibration Topics 9
Marc Ford likely to close five North American plants World News 3
B Quality and Health & Safety. How close is this link? Document Control Systems, Procedures, Forms and Templates 8
S Shiny new CAPA system! - Easy way to close the old one? Nonconformance and Corrective Action 1
P ISO 13485:2003 6.4 vs 7.5.1.2.1 - For me these paragraphs are very close ISO 13485:2016 - Medical Device Quality Management Systems 1
H Repeated tests reproducibility - Regression line is close and good Bland Altman plots Quality Assurance and Compliance Software Tools and Solutions 1
T TQM (Total Quality Management) Team Close Out Process Preventive Action and Continuous Improvement 2
A Can we close an audit NCR by not taking any action? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
S Failure to Close Out an Internal Audit Finding Internal Auditing 20
F Definition Reasonable - Defining a Reasonable Amount of Time Close Out CPAR's Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 6
S Install a CMM close to a vibration area General Measurement Device and Calibration Topics 8
D Approval of FDIS ISO 9001:2000 - They've ordered a re-count - Too close to call ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Not every INCIDENT report will lead to a corrective action EU Medical Device Regulations 6
L Separate Corrective Action and Preventive Action Procedures ISO 13485:2016 - Medical Device Quality Management Systems 13
Q Determining Adverse Effects of Corrective/Preventive Actions ISO 13485:2016 - Medical Device Quality Management Systems 2
T AS9100D Clause 10.2.1g Supplier Corrective Action for each and every nonconformity? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
D Corrective Action Timing - IATF CB Deadline IATF 16949 - Automotive Quality Systems Standard 2

Similar threads

Top Bottom