CAPA stands for ‘Corrective Action and Preventive Action‘. It is a process through which problem is investigated, root causes are identified & corrective action/preventive action is implemented. Although, the main goal of implementing CAPA is to assure that the problem will never be experienced again.
In this article, I’m going to discuss the 3 different parts of CAPA & the 7 stages involved in CAPA.
3 different parts of CAPA
Every manufacturing industry remains incomplete without a CAPA team. The team works on the three different parts of CAPA. They are as follows:-
‘Correction’ is the immediate action taken to resolve the newly occurred problem. It might be a temporary solution to the problem.
2. Corrective action
The Corrective Action is an alternative action taken to counter a defect or a non-conformity and to ensure that it does not occur in future. It comes into play when something is going wrong or has already gone wrong.
3. Preventive action
The Preventive Action comes into play when possibilities of quality failure or non-conformity are identified which can lead to future quality system failures. To put it differently, it is an active approach to prevent quality problems and implementation of steps to improve quality.
Difference b/w Correction & Corrective Action
There is a lot of confusion between “correction” and “corrective action.” Correction is when you find a problem and provide an immediate solution to it while the corrective action goes deeper and finds the underlying root cause of the problem.
Every problem needs a correction both smaller and bigger ones whereas corrective actions are only implemented on bigger problems that are repetitive or recurring. If a problem has only occurred once, then implementing and documenting a seven-stage corrective action process might be too expensive. On the other hand, if it occurs several times a month an investigation and corrective action will likely save money in the long run, as time will be saved when fewer problems occur.
Example: Changing the oil of a machine that has run out of it and is manufacturing bad parts is correction whereas finding the root cause of the problem (as in this case, waiting too long to change oil) and fixing the root cause of it by enforcing a maintenance program to change the oil on a schedule before bad parts are manufactured.
Difference b/w Corrective & Preventive Action
A common misconception is that the purpose of a preventive action is to avoid the occurrence of a similar potential problem. Which is completely false as this is also a part of the corrective action. Corrective action is a process of determining all such similarities that should take place in the event of a disagreement. Moreover, the corrective action is performed when the problem has already occurred whereas preventive action follows the same seven-stage process except that it is applied to a problem that is observed before something bad happens.
Example: A corrective action would be taking pills or medicines after getting sick even the preventive pills, but a preventive action would be taking Polio or other vaccinations in order to prevent the diseases from occurring.
7 Stages of CAPA
A successful CAPA program comprises of 7 stages. Each stage is needed to be work on thoroughly in order to achieve promising results.
Stage 1: Identification
The first stage of CAPA program is to define the potential or actual problem, nonconformity or defect, and to describe the situation as it currently exists. This is done to make sure that the problem is a real problem, not a perceived problem. A good test is if you can write the problem with a requirement to compare, what is often called a “Should Be” and “Is” statement.
Example: Parts should be nickel plated, parts were received painted black. If you can’t say what the outcome should be (or is expected to be), then you may not have identified a real problem. The complete written description of the problem should include the following: –
- Explanation of problems.
- Documentation of available evidence.
- The specific source of the information that initiated the action such as Internal audits, data trends, process monitoring, customer complaints and QA inspection.
Stage 2: Evaluation
The second stage of CAPA is to evaluate, how big the problem is to address. The problem described and documented in stage 1 is evaluated to determine the need for action and the level of action required. Is it just today’s product, or was yesterday’s product affected too? Is it just this one product, or is it on more than one product? Make sure you know what the problem is, and more importantly, what it is not. If the problem only happens on Wednesday, this may be important information. The document for evaluation must contain sufficient information to ensure that the problem is easily understood. The objective to determine the need for action and the level of action required are as follows: –
- Potential impact – The impact on company and clients in terms of cost, product quality, safety and customer satisfaction.
- Risk – The level of risk associated with the problem.
- Remedial action – The potential impact and risk assessment to help decide the required remedial action.
Stage 3: Investigation
The third stage of CAPA is to write a procedure for conducting an investigation into the problem. It aims to ensure that the investigation is complete and nothing is overlooked. The procedure should include the following: –
- Review various parameters related to a problem e.g. equipment, materials, procedures, analyst training, software capabilities and environmental parameters.
- The objective of the actions that will be taken.
- Fix individual responsibilities and resources requirement such as finances, manpower, and equipment. These requirements are worked out and documented.
Stage 4: Analysis
This is the trickiest part. It aims to identify the underlying problem, not just a surface problem. How do you make sure you have found the underlying issue? There are many different ways to do this, from asking “Why” five times until you find the ultimate cause, to more difficult methods like a classic Ishikawa (or Fishbone) Diagram. The procedure created in Stage 3 should be used to investigate the cause of the problem. This stage leads to the root cause of the problem and includes the following: –
- Collecting data and trying to list out the possible sources so as to arrive at the root cause. Data may come from such sources as records, processes, service information, operations, etc.
- Finding the root cause will not simply deal with symptoms but help uproot the main contributing factors.
Stage 5: Action Plan
An action plan to correct and/or prevent the problem should be developed based on the analysis conducted in stage 4. This action plan decides what steps are needed to eliminate the root cause of the problem. The action plan includes the following:-
- The plan includes changes to be made in existing procedures and assignment of responsibilities.
- All modifications and changes must be communicated to concerned personnel, departments, and suppliers.
- Employee training is an essential part of any change and is always part of an action plan.
- Identifying the cost and return on investment.
- How will it be funded (if it is a complicated and expensive fix), and who needs to approve the expense?
- The person/persons responsible for completing each task.
Stage 6: Action Implementation
This is as simple as following the action plan and making it happen. The corrective/preventive action plan created in Stage 5 can now be implemented. All of the required tasks listed and described in the action plan must be initiated to correct the problem and ensure it will not repeat itself. The implementation stage includes the following:-
- Execution of identified tasks.
- Modification of Documents, Processes, Environmental conditions
- Creating a complete record of the actions taken.
- Provision of training on modifications.
Stage 7: Follow-Up
This is the most important stage of CAPA and also the stage that most companies have trouble with. Often, the quality team wants to close the paperwork quickly but proper follow-up is essential. A thorough follow-up evaluation serves multiple functions. The follow up verifies completion of the identified tasks and also assesses the appropriateness and effectiveness of the action taken. After the follow-up, there should be a formal indication that it has been completed. The follow-up report must document the following: –
- If the root cause of the problem is solved.
- Any resulting secondary situations have been corrected.
- Proper controls established to prevent future recurrence.
- Actions were taken that have no other adverse effects.
- Adequate monitoring arrangements that are in place with assigned responsibilities.