Removing the Mystery of Corrective Action

Why is a CAPA System important?

Corrective Action (CA) is a requirement of ISO13485, ISO 9001, ISO 27000, ISO 14001, AS9100 as well as many more standards and Quality Management Systems.   Why do you think that is?

There are many reasons this has so much emphasis. This principle is a main driver of an effective problem-solving system.  The concept of identifying issues, investigating why they happened, and fixing the root cause so those or similar issues (nonconformances) do not recur is essential to a successful business. Eliminating waste, both in the resources, and the product is a cost-effective tool.

What does a nonconformance cost?

• • • Lost time, labor, and material for all processes up to point of identification,
    • Time and labor to contain and sort the materials
    • Customer notification if applicable, and loss of confidence (not quantifiable)
    • Time and labor to process the NC, investigate the root cause, & implement resolution
    • Documentation updates and records management
    • Do the Corrective Action: Rework, remake labor, replace materials, labor, or scrap
    • Cost of disposal
    • Follow up audit time and resources to ensure the CA is effective, and preventive action to prevent recurrence is in place and effective
    • Exponential costs based on cost of product, material, risks and complexity of processes

So, think about that for a minute.  If you have repeat nonconformances how much money, labor and time are you wasting?  It’s costly enough to have the nonconformance without repeating it and incurring that waste again.  With that in mind, you can see the added value the Corrective and Preventive Action (CAPA) process brings to the table.

What is the root cause and how do you know?

How can you ensure you have identified the root cause?  So often, we stop when we think we have reached the root cause but in reality, you have just uncovered the symptoms.  It is so easy to say Operator error.  But WHY was there an operator error?  Fix the reason the operator made the error so that no other operator will make the same error (prevention).  Often it takes asking WHY several times before you delve down to the real cause.

There are many tools to use in the root cause analysis process.  The first and most popular is the 5 WHY scenario.  This is easy to facilitate and works well for small less complex nonconformances.  Cause and effect diagrams can help you see the many potential causes and their relationships.  The 8 Discipline method (8D) problem-solving tool is popular though at first glance it might appear daunting.  Like everything else, a plan is essential to success.

What is a Corrective Action plan?

A plan is the road map.  A plan is developed and implemented to identify, remediate, and/or prevent the recurrence or occurrence of existing and/or potential causes of non-compliance or other quality problems.

Creating and implementing a CAPA plan takes a lot of time. It requires one person to “drive it” (the CAPA Owner), and an entire team of trained, motivated people.  Anybody involved in the non-compliance issue must be involved in the CAPA team.  Keep in mind, this requires learning, being open, non-judgmental, critical thinking, stepping outside your safe zone, etc.  Assign an owner and choose the team.

8 Team steps to a CAPA system implementation

1. 1. 1. Identification – what is the issue/problem? Restate the problem with quantitative, descriptive details.  Customer complaint says, “product stopped working” Define What the product is, are similar models affected, how many, how often, what are the circumstances when it stopped working, what stopped working? Totally inoperable or certain parameters.  (And so on)
      2. Evaluation – what is the impact and severity of the issue? Risk assessment! Health and safety concerns? For instance, what is the product, are similar models affected, any in the factory, distribution, or sold?  How/why was it missed?  Where was the product being used (environmental conditions) Used in accordance with its intended use/misused?
      3. Investigation – objectives, procedures, and responsibilities are defined and documented
      4. Analysis – documented root-cause analysis. Review all evidence and determine the root cause
      5. Action Plan – remediation and prevention.  How do you stop the bleeding, fix the nonconformance then prevent recurrence?  Try it out, does it cause issues elsewhere?
      6. Implementation – resource allocation, execution of the plan, documentation of all steps.  If the plan was successful implement and monitor
      7. Follow-up – verification for adherence to CAPA plan effectiveness; if CAPA plan is not effective, return to Investigation (DID IT WORK? Effectivity review must be a planned activity/action in an appropriate time frame after implementation.
      8. Congratulate the team.  Recognize the hard work in some way.

All these steps comprise the 8D process.  But the steps are not unique to 8D, any Corrective Action requires them.  The difference is the 8D collects all the information, data, and tools in one document.  The form takes many shapes and may be industry or company-specific.  What most don’t realize is you can adjust the form to meet your needs.  For instance, you often see a table with IS and IS not questions to help drill down to a comprehensive quantitative problem statement.  These questions can change based on your needs.  The mistake people make is to try to fit answers into the form where you should have modified the form with questions supporting your product/process and meeting your needs.

You’ll find there are many complex and simple analysis tools, such as Cause & Effect diagrams, the 5 WHYS, Pareto Analysis, Histogram, Business Process Mapping, Lean, and Six Sigma.  Choose the tool appropriate to the depth and complexity of the problem.  Data analysis and evaluation will help you find the solutions you need for each CA.   The more you use the system, the more effective it will become.