CAPA Process with Example

CAPA Process

CAPA Process | Examples

Hi readers, here we are going to discuss the details of the CAPA Process and the ISO standard requirement of concept capa and also describe here with definition and comparison with the new ISO 9001:2015 and IATF 16949:2016 Standard.. as we know the capa word is common in the industry and used for improvement purposes.

Definition of CAPA:

The full Form of CAPA is Corrective Action and Preventive Action. Action to eliminate the root cause of Non-conformity is called Corrective Action. Preventive action is the action to eliminate the potential cause of non-conformity.

Download the Correction and Corrective Action Format/Template.

 Concept of CAPA Process in ISO 9001:2015:

According to the new standard ISO 9001:2015, there is no separate clause or sub-clause of preventive action. So now in ISO 9001:2015, preventive action is expressed through the use of risk-based thinking.

CAPA is the combination of two major parts one is Preventive action in the form of Risk, a mitigation plan, and current controls. And another is Corrective Action which has a separate main clause in ISO 9001:2015 Standard in Clause no 10.2.

 The main clause 10.2[
Non-conformity and corrective action] has described as

-The organization shall react to non-conformity and will take action to control and correct it.

It means basically asking for the action plan to element the root cause of non-conformity and evaluation of consequence and effectiveness of action and also asking for updating the risk and opportunity.

In the sense of CAPA in ISO 9001:2015 we have to retain documented information as evidence of [1] the Nature of non-conformity and subsequent action taken [2] Results of corrective action [3] Risk Register [4] Current control[5] Mitigation plan of significant risk.

Download the Correction and Corrective Action Format/Template.

Download the CAPA Format/Template.

Similarly Concept of the CAPA Process in IATF 16949:

The concept of CAPA w.r.t IATF 16949 is the combination of ISO 9001:2015 requirements along with the supplemental requirements of IATF 16949 as [1]Problem-solving [2] Error-Proofing [3] warranty management system [4] customer complaint and field failure test analysis.

Let us understand the supplemental requirements very well. In the section on Problem-solving, Correction, corrective action, containment action, root cause analysis, and effectiveness of corrective action need to be formulated. And also asking to update your PFMEA, DFMEA, and Control plan [if required].  And also similarly asking about the correction, corrective action, and effectiveness of action taken on warranty products, customer complaints, and field failure.                          

Let us take an example here to explain details about the Correction and corrective action:

Say, for example, Customers found damaged products at their end.

So here on the basis of the above complaint, OEM-Automotive Company may ask for 8D. Similarly for this problem, other companies can ask for a correction and corrective action plan. so first of all we will talk about correction, corrective action, containment action, and then document updation.

Containment/Correction Action: Immediately all products should be rechecked at the Dispatch Area before supply to the customer.

Corrective action: Here we need to identify the Root cause of Non-conformity by why-why analysis

Why- 1-Why Damage the product at the customer end?

Ans.- Due to the loose Packaging.

Why-1-Why Loose Packaging?

Ans.- Due to missing out of buffer element

Why –Why missed out of the buffer element?

Ans.- There was not 100% visual inspection to identify such a problem.

Action Plan: 100% Visual inspection will be executed before final packaging.

Document Updation: Control plan, PFMEA.

With the help of the CAPA (Corrective Action & Preventive Action) process, you can improve your process.

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CAPA Example | Manufacturing examples | CAPA Meaning

CAPA Example

CAPA Example | Manufacturing examples | CAPA Meaning

Hi Readers! Here, we are going to discuss on the most popular topic of the manufacturing industry is namely termed as CAPA Example. Firstly, we will be knowing details on CAPA meaning. The full form of CAPA is Corrective action and Preventive action. Where problems, issues, and any type of non-confirmative presence, there CAPA is required. In manufacturing units CAPA is most important and commonly used for problem solving and process improvement. Now we are going to discuss several manufacturing practical CAPA examples in different operations like quality, production, maintenance, purchasing, and HR functions.

Download the CAPA Template or Format with an Example

CAPA Example
CAPA Example Format

CAPA Meaning:

The CAPA means Corrective Action and Preventive Action. The action to eliminate the symptoms of the problem is called a correction. Action to eliminate the root cause of the problem is called corrective action. The action to eliminate the potential cause of the problem is called preventive action.

CAPA Example, capa meaning
CAPA Meaning

CAPA Example:

Practice makes you perfect, in line with this sentence, here we are going to practice some CAPA Example in Manufacturing Industry covering with different and different operations like quality activities, SRM, lab activities, purchase activities, etc. The main important part of the CAPA report is the root cause analysis, for doing the RCA the most commonly used tools are the why-why analysis or 5-whys analysis & the 2nd important part is systematic corrective and preventive action. CAPA report is commonly required where there are any issues, problems, risks, defects, warranty, customer complaints, & non-conformities.

Following are the steps that you can follow to write the CAPA report in simple ways.

  • Identify the problem, issue or non-conformity.
  • Define and describe the problem for a better understanding of the background of the problem.
  • RCA -root cause analysis (common tools -why -why analysis or 5 whys)
  • Action plan with a target date and responsibility (Correction, corrective action,, and preventive action, a common format is CAPA format or template, 8D report, etc.)
  • Implement an action plan.
  • Effectiveness monitoring.
  • Document standardisation
  • If applicable then, horizontal deployment.

Now I am going to discuss here some popular Manufacturing examples in different operations like a laboratory, quality, customer complaints, process issues or problems, etc.

CAPA Example in Laboratory:

Let’s consider that a wrong TC (test certificate) has been generated at the laboratory and the same TC was communicated to the customer. For the same case, you are supposed to submit the CAPA report.

CAPA Report:

Process: laboratory operation.

Item: PQR, Date: dd/mm/yy.

Identification of problem: Wrong TC had been generated and communicated to the customer

Correction/ Containment Action: Checked the other TC & verified that all TC are OK, Target Date: dd/mm/yy, Responsibility: Mr. SGP.

Why-Why Analysis or 5 Whys Analysis:

Why1: Wrong TC had been generated

Why2: Human Error

Why3: An Intermediate checking system was not available.

RC (Root cause): An Intermediate checking system was not available.

Corrective Action Plan:

Corrective Action: Intermediate checking system will be developed, Target Date: dd/mm/yy, Responsibility: Mr. SGP.

Preventive Action Plan: [1] Preventive Action: Refresh Training, [2] Two layers checking of TC before releasing to customer. Target Date: dd/mm/yy, Responsibility: Mr. SGP.

Verification of Implemented Action Plan: Checked that SOP has been made and implemented in the lab, Verified by: Mr. P.

Effectiveness Monitoring Status:  Monitoring the monthly TC Status of OK or not OK, Remarks: No such error found in the last 3 months report.

Document updation / Standardization:

  • SOP: X
  • Check sheet:
  • Control Plan: X
  • FMEA: X
  • R&P record: X
  • Others:

Remarks: SOP has been made, Control plan, PFMEA, R&P has been updated w.r.t action plan.

CAPA Example
CAPA Example Format or Template

Customer Complaint CAPA Report:

If you received any customer complaint and your customer is asking to submit the action plan and they have not mentioned any specified format then you can use the CAPA format or 8D report template for submitting the action plan. But many customers use the digital platform as SRM- supply relationship management portal to upload the action plan in their specified template.

You can follow the above-mentioned steps and can do refer to the above example for formulating the CAPA report in any type of customer complaint. Nevertheless, we are taking a simple customer complaint example for CAPA report formation.

Let’s consider a company manufacturing the automobile part and selling it to OEM customers. Unfortunately, a customer complaint was received due to a machining issue of a part PpP.

Process: Moulding operation

Item: PpP, Date: dd/mm/yy.

Identification of problem: Machining issue of a part PpP.

Correction/ Containment Action: Checked the other produced parts, inspected the dimensions and segregated the NG parts, Target Date: dd/mm/yy, Responsibility: Mr. SGP.

Why-Why Analysis or 5 Whys Analysis:

Why1: machining issue of a part PpP.

Why2: The machining dimension was less as per the drawing.

Why 3: The core setting at mould operation was not adequate.

Why3: New operator

RC (Root cause): Lack of knowledge of new operators

Corrective Action Plan:

Corrective Action: On-job training will be imparted to new operators, Target Date: dd/mm/yy, Responsibility: Mr. SGP.

Preventive Action Plan: [1] Periodic training evaluation [2] Training effectiveness monitoring [3] Training feedback. Target Date: dd/mm/yy, Responsibility: Mr. SGP.

Verification of Implemented Action Plan: training has been imparted to the operator and the skill matrix is being monitored for performance measurement of operators, verified by: Mr. P.

Effectiveness Monitoring Status:  Monitoring the monthly operator’s skill matrix for performance measurement, Remarks: No such error found in the last 3 months.

Document updation / Standardization:

  • Training SOP:
  • Check sheet:
  • Control Plan:
  • FMEA:
  • R&P record:
  • Skill matrix.
  • 4M Change.

Remarks: The above documents are updated but these are not limited to.

I hope the concept is clearly understood and now you can easily prepare the CAPA report.

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