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Evidence Guide: FBPPHM4006 - Respond to non-conformance

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

FBPPHM4006 - Respond to non-conformance

What evidence can you provide to prove your understanding of each of the following citeria?

Identify non-conformance

  1. Interpret workplace procedures and documentation relevant to non-conformance
  2. Identify nature of non-conformance
  3. Follow non-conformance corrective and preventive action (CAPA) according to GMP requirements and workplace procedures
Interpret workplace procedures and documentation relevant to non-conformance

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Identify nature of non-conformance

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Follow non-conformance corrective and preventive action (CAPA) according to GMP requirements and workplace procedures

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Identify causes of non-conformance

  1. Investigate possible causes of non-conformance
  2. Conduct root cause analysis (RCA) to determine cause of non-conformance
  3. Conduct non-conformance risk assessment on current and previous material according to workplace procedures
Investigate possible causes of non-conformance

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Conduct root cause analysis (RCA) to determine cause of non-conformance

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Conduct non-conformance risk assessment on current and previous material according to workplace procedures

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Review processes to minimise risk of recurrence

  1. Assess and select solutions to eliminate or minimise the risk of recurrence
  2. Develop an implementation plan for risk minimisation solutions
  3. Conduct CAPA effectiveness checks according to GMP requirements and workplace procedures
  4. Establish consultative mechanisms and communicate implementation plan to support continuous improvement according to GMP requirements and workplace procedures
Assess and select solutions to eliminate or minimise the risk of recurrence

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Develop an implementation plan for risk minimisation solutions

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Conduct CAPA effectiveness checks according to GMP requirements and workplace procedures

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Establish consultative mechanisms and communicate implementation plan to support continuous improvement according to GMP requirements and workplace procedures

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Required Skills and Knowledge