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Evidence Guide: FBPPHM4001 - Monitor and maintain Good Manufacturing Practice requirements

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

 

FBPPHM4001 - Monitor and maintain Good Manufacturing Practice requirements

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

Empower team members to identify GMP requirements

  1. Ensure personal protective equipment and contamination prevention clothing used by team members is serviceable and fitted correctly according to work health and safety requirements
  2. Ensure GMP requirements and workplace procedures are available
  3. Identify and address training needs according to team member's level of responsibility
  4. Provide training and coaching to support individuals and groups to implement GMP requirements and related workplace procedures
  5. Demonstrate personal hygiene to others to support implementation of GMP requirements and workplace procedures
  6. Monitor and control resource allocation according to workplace procedures and GMP requirements
  7. Ensure GMP control measures used in the work area are identifiable by workers
Ensure personal protective equipment and contamination prevention clothing used by team members is serviceable and fitted correctly according to work health and safety requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure GMP requirements and workplace procedures are available

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and address training needs according to team member's level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Provide training and coaching to support individuals and groups to implement GMP requirements and related workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Demonstrate personal hygiene to others to support implementation of GMP requirements and workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor and control resource allocation according to workplace procedures and GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure GMP control measures used in the work area are identifiable by workers

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor personal hygiene and conduct of team members

  1. Ensure personal hygiene of work team meets GMP requirements
  2. Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures
  3. Ensure personal movements within workplace comply with area entry and exit procedures
Ensure personal hygiene of work team meets GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare, use, store and dispose of personal protective equipment and contamination prevention clothing according to GMP requirements and workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure personal movements within workplace comply with area entry and exit procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor implementation of GMP requirements

  1. Clearly define, document and follow GMP requirements in work area
  2. Conduct a root cause analysis (RCA) as part of a cross-functional team and report non-compliance(s) from workplace procedures
  3. Identify and report GMP non-conformance(s) and signs of unacceptable plant or equipment condition
  4. Put in place quality approved corrective action or preventative action (CAPA)
  5. Record information according to workplace reporting procedures and to meet GMP requirements
  6. Ensure team members maintain work area according to workplace cleaning standards
Clearly define, document and follow GMP requirements in work area

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct a root cause analysis (RCA) as part of a cross-functional team and report non-compliance(s) from workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and report GMP non-conformance(s) and signs of unacceptable plant or equipment condition

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Put in place quality approved corrective action or preventative action (CAPA)

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Record information according to workplace reporting procedures and to meet GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure team members maintain work area according to workplace cleaning standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain and facilitate continuous improvement of GMP

  1. Identify, report and correct processes or conditions which could result in GMP non-conformance according to individual level of responsibility
  2. Promptly resolve matters relating to GMP or refer them to appropriate personnel
  3. Monitor effectiveness of CAPA and control measures according to level of responsibility
  4. Advise others in the work area of GMP matters relevant to their work role
  5. Maintain workplace records and documents according to workplace procedures and GMP requirements
Identify, report and correct processes or conditions which could result in GMP non-conformance according to individual level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Promptly resolve matters relating to GMP or refer them to appropriate personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor effectiveness of CAPA and control measures according to level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Advise others in the work area of GMP matters relevant to their work role

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain workplace records and documents according to workplace procedures and GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Required Skills and Knowledge
Range Statement

This section specifies different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Personal hygiene must include:

informing team leader or supervisor of any reportable illnesses

removal of jewellery, including:

rings

watches

bracelets

removal of makeup.