Timely Closure and "Ongoing" Corrective Action

tori2432

Involved In Discussions
#1
Just started at a new company and reviewing management review. There is a 2 year old corrective action that is 'on-going'. I don't like seeing the 'on-going' word on any corrective action. It should have a quick end date, or shouldn't it?
 
Elsmar Forum Sponsor

cbhigdon3

Starting to get Involved
#3
re: Timely Closure and "Ongoing" Corrective Action

A good third-party auditor from one of the major CBs would be all over this one and, depending on their strictness, might even write you up for a second finding in that the corrective action system is not effective and that there is no validation activity performed. Ongoing CAs bear the hallmarks of a previous individual (or individuals) that don't want to receive a finding from their CB, so they create a corrective action preemptively in order to demonstrate that the "organization is taking care of it" - except they never actually implement the CA just keep it open so that they don't get a finding on future audits.

Generally, 30 days out is about the limit that most of my customers want to see for the full CA/PA cycle.
 

Ajit Basrur

Staff member
Admin
#4
Just started at a new company and reviewing management review. There is a 2 year old corrective action that is 'on-going'. I don't like seeing the 'on-going' word on any corrective action. It should have a quick end date, or shouldn't it?
Yes, ideally we all love to see corrective actions closed in a timely manner (and complies with the procedural requirements). But certain CAs require a longer time for closure and effectiveness.

I do not mind the CA as "ongoing" provide there is some traction and not just lying dormant and unattended.
 

Golfman25

Trusted Information Resource
#5
Having a preconceived timeline for closure of a CA just means you're looking for feel good solutions. Not every problem is the same. Some I can close in 24 hours. Some may take a year or more. The real issue is whether progress is being made and how it is progressing.
 

Sebastian

Trusted Information Resource
#6
Every auditor has own personal corrective action/timing matrix, e.g. effect of seeing "2 years for procedure revision" definitely will bring a smile on her(his) face.
Final report said:
Organization strong point - documented information reviewed and updated in a very cautious manner.
;)

Seriously, in the past I get 1 NC for poor corrective action management connected with ineffective escalation process. Auditor found I had reported to president open CAR few times, but he didn't react to it in any way.
 
Last edited:

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
It should have a quick end date, or shouldn't it?
No, quickies are, for the most part, not satisfying...:tg: The time needed for the "once-and-for-all-put-to-rest" corrective action will have to be commensurate with the complexity of the issue and the nature of true corrective action. Much better to have a monitored, gradual, "slow" but sure corrective action than a fast one that just turns into a band-aid.

Generally, 30 days out is about the limit that most of my customers want to see for the full CA/PA cycle.
And, sometimes, that means that you are pretending to perform corrective action and they, your clients, are pretending to perform supplier oversight. Some problems will demand a thorough, time-consuming investigation. Some corrective actions might demand the procurement of capital equipment, something that has budgetary implications, not solvable in 30 days. As long as artificial deadlines are present, we will end up with band-ais, recurring problems.

We must not forget that, in addition to corrective action, correction and containment are also part of the process to address nonconforming products. Sometimes, containment has to be in place for a while, until true corrective action is in place.
 

Kronos147

Trusted Information Resource
#8
What if the containment is "don't take these orders" and corrective action is "save up and buy a $xxx,xxx machine"?

How long is reasonable?

If continually reviewed (management review? corrective action process?) including evidence, then why a problem with an ongoing CA?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#9
I agree that CAs can't have a 'set' time frame for completion - unless you want your CAs 'pencil whipped'. As long as the actions and planned actions make sense and are actively being pursued I see nothing wrong in a 'long time' CA. This does take more work to manage as we must have a good working understanding of what the CA team is doing and why; but isn't that our job?

I have an open CA now that is nearing it's 3rd birthday. I can tell you that it has been extremely active. we implemented containment within 3 days of discovering the problem, improved the containment action 3 times in the next 6 months while pursuing an understanding of causal mechanism which led to a redesign and will require approval by a regulatory body. These things can take time to ensure an effective solution that prevents re-occurrence, but I am more than comfortable with our approach and can defend it to any auditor as our work and the data speaks for itself.

No where in the standards is a timeframe proscribed. Timeliness is a relative term. What is proscribed is that when a nonconformance is severe enough we need to determine the root cause and implement solutions that prevent re-occurrence...
 

Mike S.

Happy to be Alive
Trusted Information Resource
#10
I agree with Bev and others who say artificial time limits don't work for all situations.

Again, Pareto is alive and well. Maybe a large majority can be completed in a relatively short time frame like 30-60 days if reasonable effort is made, but a small percentage may take a long time to do a good job on, especially if the production is sporadic.

In situations where they take a long time to fully close, I still make provisions to protect the customer in the interim with containment, correction, and temporary corrective actions like 100% inspection whenever possible.
 
Thread starter Similar threads Forum Replies Date
M Benchmarking - Timely Closure of Corrective Actions Nonconformance and Corrective Action 3
K FAA Audit - Major nonconformity for lack of timely calibration of two devices EASA and JAA Aviation Standards and Requirements 5
J Specific Actions where Timely and/or Effective Actions are not Achieved Nonconformance and Corrective Action 6
M Definition Timely - Definition of "timely" in AS9100 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
S TS 16949 Clause 4.2.3.1 - Process to assure timely review - Two weeks IATF 16949 - Automotive Quality Systems Standard 2
Mikishots How to handle CAR (Corrective Action Request) Scope vs. Timely Response Nonconformance and Corrective Action 9
S TS 16949 Requirements for Timely Review of Engineering Specifications IATF 16949 - Automotive Quality Systems Standard 6
E C/A (Corrective Action) not closed in a timely manner Nonconformance and Corrective Action 26
P Convincing Suppliers to Send 8D Reports and React to Complaints in a Timely Manner Supplier Quality Assurance and other Supplier Issues 24
T TS 16949 - 4.2.3.1 Engineering Specifications - Process to assure timely review, etc. IATF 16949 - Automotive Quality Systems Standard 1
R AS9100 Revision A - Timely and effective corrective actions not achieved AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
H Timely Review of Engineering Specifications - 4.2.3.1 - Two Weeks? IATF 16949 - Automotive Quality Systems Standard 14
D Customer Specifications - Timely review (e.g. business ?days?, not weeks or months) Document Control Systems, Procedures, Forms and Templates 14
M Timely Response for Preventive Actions - How can we assure a timely response? Nonconformance and Corrective Action 5
Q Internal Audit of a Plan or other document - Closure Plan Internal Auditing 1
Q Evaluating Effectiveness of a Preventive Action after Closure Preventive Action and Continuous Improvement 7
Q Incomplete Process Sheets Closure - DHR - Doc Control Document Control Systems, Procedures, Forms and Templates 3
B Analysis & Closure of a Customer Complaint Customer Complaints 6
Casana Corrective Action - Requirements for Closure? IATF 16949 - Automotive Quality Systems Standard 6
Q Non Conformance Closure by including it on another Corrective Action ISO 13485:2016 - Medical Device Quality Management Systems 8
S Internal Audit Closure Certification Report - FDA Requirements US Food and Drug Administration (FDA) 5
I CAPA Closure for a seldom produced item Nonconformance and Corrective Action 18
J AS9100 Third Party Nonconformance Closure Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C Closure of CARs (Corrective Action Requests) and Audit Observations Internal Auditing 25
N Company Closure and ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Container Closure Integrity & Sterility Test - The Dye Immersion Method Quality Assurance and Compliance Software Tools and Solutions 16
D Non Conformance Closure - Shouldn't this be the Quality departments responsibility? Nonconformance and Corrective Action 3
K Is an Internal Audit Closure Certificate required? Internal Auditing 10
bobdoering GM prepares to announce Pontiac closure next week Coffee Break and Water Cooler Discussions 1
6 Beverage Bottle Closure - Torque Problems - Rotary Cappers Manufacturing and Related Processes 6
M Complaint Closure - Auditing the Complaint Department ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Gap Closure and Internal Audits - Is this auditing our own work? General Auditing Discussions 5
D Relationship between ANOVA and measurement accuracy - Mechanical strenth of a closure Statistical Analysis Tools, Techniques and SPC 13
R Updated Process FMEA: How much detail? Closure of an External Corrective Action FMEA and Control Plans 3
E Cpk or Ppk in packaging closure manufacturing? Capability, Accuracy and Stability - Processes, Machines, etc. 2
M Informational EU – Ongoing Guidance development within MDCG Subgroups Medical Device and FDA Regulations and Standards News 1
G Managing Ongoing Compliance to Standards when they are Changed Misc. Quality Assurance and Business Systems Related Topics 3
M Is Validation an ongoing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
G Ongoing Cpk and Global/Historical Data Statistical Analysis Tools, Techniques and SPC 7
G Cpk, Subgrouping, and Can Attribute Charts Monitor Ongoing? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
C An ongoing EMC test in accordance with IEC/EN 60601-2-47 EMC IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D Ongoing Stability Testing required for DES? Drug Eluting Stent EU Medical Device Regulations 4
G Change of procedure for handling new projects - do the ongoing ones need to follow? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Audit questions and plan for ongoing audits of ISO13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 5
M Sustaining the 5S (Five S) Program - What can I do to keep the effort ongoing? Quality Tools, Improvement and Analysis 2
M 4.9.2 Maintaining Process Control - Maintaining ongoing process capability QS-9000 - American Automotive Manufacturers Standard 13

Similar threads

Top Bottom