Effectiveness Check of a Manufacturing Process
By: Dominic Doruem Nwagbaraocha
The concept of effectiveness check can be applied to other topics. However, let’s talk about CAPA/KAIZEN Effectiveness check, which is a measure and determination that the defined CAPA will or has eliminated the problem.
Any of this methods could be used;
- Trend analysis,
- Periodic checks ,
- Surprise audits,
- Sampling.
Click Here to Download Readymade Editable Toolkits & Templates on Quality Assurance/Quality Control, Lean Six Sigma, Lean Manufacturing, Six Sigma, ISO 9001, ISO 14001, ISO 22000, ISO 45001, FSSC 22000, HSSE, Project Management etc.
A key factor to consider in conducting effectiveness check is 'timing', usually within 1 – 3months.
Why CAPA plans should go through effectiveness checks:
- To build confidence that the proposed solution will work.
- To validate that the solution worked.
- To eliminate the risk of reoccurrence.
Methods effectiveness checks.
- Verification consists of actions taken beforehand to make sure remediation plays out as expected. You could just go forward a few weeks and see the results of your actions.
- Validation is done after implementation to ensure the solution worked.
- Choosing the Appropriate Measurement.
Click Here to Download Readymade Editable Toolkits & Templates on Quality Assurance/Quality Control, Lean Six Sigma, Lean Manufacturing, Six Sigma, ISO 9001, ISO 14001, ISO 22000, ISO 45001, FSSC 22000, HSSE, Project Management etc.
To measure success of a CAPA:
- Qualitative methods through intensive collection of narrative data, generate a hypothesis to be tested.
- Quantitative methods explain, predict, and/or control phenomena through focused collection of numerical data and hypothesis testing.
Effectiveness checks is the best way to track, trend, and remediate deviations that occur during manufacturing or business processes.
Risk-based
What you choose to do for verification and validation needs to be based on risk. A high-risk change warrants more effectiveness checks and more expense.
Dominic is a process & quality consultant with over 10 years’ experience leading various continuous improvement in world-class organizations. founder of Doruem Process Services and Co-Founder to Nodal Point Engineering, with core competence in manufacturing excellence and digital manufacturing.
You can reach him on LinkedIn here.
