PRAKASH RANA CAPA. is simple. Just follow basic law

🦋 Jessica Grusell So true!

True

Michael Chellson, RAC Prakash, I would agree that the "process" should be simple. However "basic Law" does not provide guidance on how to use the process. The execution of the process and the decision making on when or when not to apply the process is quite "involved".

That is the compelling reason to implement a harmonized and simple CAPA strategy, to standardize decision making (and documenting that decision making based on facts, not opinions) within the process to ensure organizations are working on the "important" things, and can justify their decisions.

CAPA is not difficult if you know what to look for, you understand the problem, you know what causes it, you know how to prevent it. It may be simple or complex, depending upon the design of the product.

Luigi Torre Probably a problem is that sometimes it is difficult to determine whether an action is preventive or corrective. If you have a non conformity, it is clear that the action you undertake to solve it is a corrective action. On the other hand, if you discover a hidden problem that could result in a NC, this should be a preventive action. However, the boundary is not always very clear.

Domingo Garcia-Gorritz BSc. ASQ - CQA, CMQ/OE CAPA could be difficult if everyone has the answer before we identify the problem.

Michael Chellson, RAC I abhor the acronym CAPA! One of my points is that it doesn't matter whether an ACTION is corrective or preventive in nature.

Best practices dictate that we review ALL feeder data for determination of the need and priority of taking ACTION when results or trends indicate that we are not meeting our established end points.

Whether an ACTION is corrective or preventive is a distinction without a difference as it applies to the process of executing ACTIONS.

Prevention comes from the regular and methodical analytical review of performance metrics, not from any one instance of nonconformity.

PRAKASH RANA I am agree with Michael, Preventive action not rise from nonconformity. We can do correction on nonconformity and Initiate corrective action.

Domingo Garcia-Gorritz BSc. ASQ - CQA, CMQ/OE Is your CAPA system helping your improvement process or are you feeding your process and not getting a ROI? The process must help the people improve the quality of the products and services and used regularly.

Devendra Aher PMP® Interesting viewpoint of managing internal CAPA's. Thanks for sharing. Although as I understand, there are 7 necessary steps and not just 6 as mentioned above. Documentation of procedures and processes followed is 6th before the last one stated above as per FDA guidelines.

Michael Chellson, RAC Yes. Documentation is a given. If it isn't documented it didn't happen

David Lim, Ph.D. RAC, CQA Generally, people don't know what/how to do it or have no willingness to follow established procedures. For example, the RA/CA VP of Zimmer opened a CAPA to exact a personal vendetta against Senior Director of Quality Assurane when he was at Terumo. I advised him that is not what the CAPA is for. This is public information.

It's only difficult if you don't have buy in at all levels and if you don't evolve your processes to become better.

🦋 Jessica Grusell Interesting reading! In my experience there is generally very low knowledge about what CAPA is and people do not really dare to ask since it is a common language and they believe they are supposed to know. I have learnt in my role that there is always need for pragmatic training in the definitions and the process steps. Many companies do not realize this and non efficiency comes as a result (and symptomatic work only). Make people understand what CAPA stands for, why we need it and how to apply... Keep it simple!

Very true. In my experience it's about knowing when to utilize the capa system. It should be simple and yet so many firms complicate it.

Karen Boyd, ASQ CQA Great post!!
I agree that CAPA should be basic, but is often misunderstood or not fully understood.
CAPA is a step-by-step progressional problem solving / enhancement tool that should be taught and understood as such. If one element of the process is not robust, or incomplete, the synchronization of all CAPA parts and integrity of the whole is insufficient and ineffective, IMO. Use layman terms or simplified prompts / questions to hone in on each step and extract the information needed to fulfill each element (what, where, when, why, how).
CAPA is not just limited to audit nonconformities, opportunities, or findings, but is integral to any process that can and has experienced deficiencies in need of correction and/or improvement.

Domingo Garcia-Gorritz BSc. ASQ - CQA, CMQ/OE Rachel, part of the problem with systems is that they are formalized with procedures that are written by people that understand the systems but they are not writers. It is not easy to write clear procedures specially if you are an SME. It takes a lot of effort to simplify knowledge and find the right level of your audience. It is not impossible and with the enough time it can be done. My rule of thumb is that it takes six hours per document page including research.

Gordon Skiba The problem with having a single CAPA process is it typically requires a dedicated Corrective Action Review Board (CARB or CAB); this group usually entails senior staff overseeing the CAPA process. It is there responsibility to formally authorize and assign CAPA project to the owner of the process, with the expectation the assignee will complete the activity a given due-date.

CAB's typically meet weekly or bi-weekly, hence an issue might sit idle for 5-10 days awaiting their review. These groups get deluged with requests to update processes, disposition nonconformance’s, or requests for improvements that should be handled at a far lower-level. Having a system that funnels everything into one (1) process I believe would be overwhelming.

So-called hidden CAPA systems utilized in Quality Management System (QMS) processes are in-place to allow staff to address nonconformances or short-comings in processes, products or services at the level the issue occurs. The intent is to allow the process owner to improve their processes and products (i.e., empowerment), rather than generating Corrective Action Requests (CAR) for review by the CAB.

It's a given process/product improvement training needs to be provided to all process owners to assure they fully understand their responsibilities related to improvement activities; but a company’s greatest asset is its personnel, I believe investing in their education will only benefit the company in the long-run.

Most process-owners are typically far better equipped to make a determination as to the improvement required, than is a group of persons who don't intricately know the process/product.

I'm used to having self-supporting processes (i.e., enabling improvement without having to generate a CAR), and these improvements aren't hidden nor lost, as process owners are required to report their activities to management, hence there is visibility.

By having individual groups (Inspection, Manufacturing, Design, Procurement, Document Control, etc.) reporting on the issues they face, Management is better able to allocate resources to those groups most in need of improvement.

My preference for use of a CAR or CAPA is to address those issues that are outside the responsibility, resources, or technical-ability of the process owner, when an issue can't be readily addressed within a timely-fashion or where an issue presents an unreasonable risk to end-user; or delay in the manufacture of a product/service.

Many of the better CAPA systems I've seen employ a derivative of the Define, Measure, Analyze, Improve, Control (DMAIC) methodology, while I've found the two crucial elements deal with Risk Assessment, and a Verification of Effectiveness (VOE).

Verification and Validation (V&V) are not the same as VOE; a V&V addresses only known process/product constraints at the time it is conducted, and its conclusions are typically based upon a relatively small sample-size, whereas closure of a CAPA based-upon a VOE utilizes trending of a complaint, nonconformance, or improvement over a defined period of time and/or volume of product/service.

Only following the successful conclusion of a VOE, would I consider any change to be truly effective.

I believe it is considerably easier and more effective to spread-out the responsibility for improvement processes over a larger area, than to concentrate everything into one group.

Dependent upon Managements Review of the individual processes, they can decide which of the issues they've reviewed may warrant additional oversight, and initiate a CAR or CAPA accordingly.

In closing; as long as your processes and any related issues, corrections or improvements are documented and formally reviewed, you shouldn't have any problems with an auditors review of your QMS

Michael Chellson, RAC I disagree that the action process requires a centralized decision making "board or team". And agree that local decision making is more efficient and ensures the best SMEs to make the analysis and decision.

I am not advocating one "procedue" for alll, but advocate one "process" where ever it is used in conjuction with centralized data collection to simplify the identification of trends and resource utilization. As a Manger I don't want disparate groups potentially duplicating efforts on non priority issues.

This centralized action process data review provides total visibility of all issues and allows better resource allocation decisions by management.

James (Jim) Dent, LSSBB, DTMx2 CAPA can be difficult or easy. However, it also depends on your definition of difficult and easy.

I see a few area that tend to pose difficulty for some.

'-- Defining or Identifying the Root Cause(s) - with an emphasis on the plural of 'cause'. Many times there are a series of root causes that led to the failure. Many people tend to stop once they "a" root cause; and not digging deep enough to understand there may be a set of inter-related root causes that contributed to the overall failure. Another aspect of the root cause is determining the variables of the root cause itself. Often the root cause is not simply black and white - but has it's own variable set of values. Determining what variable value contributes to the failure is important. An example of a variable might be "who" approved a test report or design report - it could be any of 5 personnel.

'-- Verifying the Root Cause - can be difficult or inconclusive if there are more than one root cause acting together - even more so if the failure seems to be random rather than consistent.

'-- Preventive Actions - this can be extensive if the root cause(s) is determined to be wide spread involving many personnel and many documents.

In agreement with Gordon I have found that many people have difficulty distinguishing between V&V and verification of effectiveness (VOE). Those who do understand that these are different often settle on, "If the issue does not recur withing 30 days of implementation then the action has been effective." What if one of the causes was a year-end condition, or a leap-year condition, or a 94-year old male with albinism with exposure to a rare virus?

I am also of the school that thinks that not every corrective action (prevention of rucurrence) needs to spawn a preventive action but that there should always be evaluation of the need for PA (usually involving change to a documented procedure) based on risk, severity and safety. VOE of a PA is very different from, and much more challenging than, VOE of a CA.

I've never seen 100 likes on a discussion in the Medical Devices Group forum, Michael. Well done!

Michael Chellson, RAC Thanks Joe!

CAPA is such a "Bugaboo" for most organizations and it's indeed an FDA "Target".

It seems that no matter how well an organization does it, there is always something inspectors find wrong.

Contact me offline. If you come to http://medgroup.biz/About-10x, let's have you speak at the Conference!

Gordon Skiba When reading this article, and noticing "ONE fully integrated “ACTION" process", "too many processes to manage" and "hidden processes". I never imagined this article meant to address a "centralized data collection" system.

My point was I didn't agree with inserting methodology for CAPA into all associated processes where corrective actions take place, just as I won't re-iterate the requirements for record control or training due to their redundancy.

Resource management affects all companies, and I'm not sure how a "centralized action process" would facilitate the allocation of resources. I agree the sharing of data is crucial for the proper allocation of resources, but I'm used to sharing my group’s activities during our staff and management meetings; which is essentially a summation of daily staff and project meeting updates.

It all comes down to communications, and cross-functional group interaction.

Senior management (CEO, CFO, and COO) determined corporate goals/objectives; as managers, it was our responsibility to allocate resources based upon these company priorities.

As a manger, it was expected we knew our staff-loading, and if additional effort was required to meet a goal, we contracted the resources necessary to assure its completion. This involved more than looking at our staff’s weekly project/activity time-sheets.

I've also worked with centralized data collection systems intended to capture data from all points (manufacturing, document control, engineering, quality, purchasing) within our QMS.

I found the system we'd used was lacking, whereas the system was created for a broad-spectrum of users, and it didn't fit well with the culture of the company.

We had no in-house experts on its use, any changes to the system required communications with a systems designer in California just to generate a new report, or to request a change to a data field.

This system was little more than a centralized data repository; we could download data, and then import it into a Word/Excel file to properly chart/display said data.

The servers for our system were in CA too; there were inevitable delays in both service requests, as well in application (waiting for upload/download of data), and this service wasn't free. Any changes to the system required a Purchase Order, besides our annual fee for its use.

Having experienced both off-the-shelf (purchased) QMS processes and data collection services; I'd be hard-pressed to say they simplified our data collection or compliance (21 CFR 820/ISO 13485).

I prefer developing our own processes and systems in-house, which includes our own servers.

This allowed us to tailor/create systems specifically for our applications, to develop in-house experts that can service the system in order for changes to be made readily, and assures acceptance by all groups within the company, as they know their inputs and needs were addressed during the processes/systems creation.

If you're allocating having a centralized server to capture all groups data, then I'm all for it.

Speaking for myself; I'm unaware of any application that allows data from product realization, manufacturing, suppliers, audits, metrology, product returns, complaints, training, facilities, document/record control and lastly, capa to be integrated seamlessly into one (1) system to enable a manger to predict resource allocation, or to provide traceability of a single component from inception to distribution in a final product...