Elements

Performance Criteria

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1. Empower team members to identify GMP requirements

1.1 Ensure personal protective equipment and contamination prevention clothing used by team members is serviceable and fitted correctly according to work health and safety requirements

1.2 Ensure GMP requirements and workplace procedures are available

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

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

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

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

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

2. Monitor personal hygiene and conduct of team members

2.1 Ensure personal hygiene of work team meets GMP requirements

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

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

3. Monitor implementation of GMP requirements

3.1 Clearly define, document and follow GMP requirements in work area

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

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

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

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

3.6 Ensure team members maintain work area according to workplace cleaning standards

4. Maintain and facilitate continuous improvement of GMP

4.1 Identify, report and correct processes or conditions which could result in GMP non-conformance according to individual level of responsibility

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

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

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

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

Skill

Description

Reading

Interpret key information about GMP requirements in workplace procedures

Writing

Prepare GMP training documentation using structure, technical language and format appropriate for purpose and audience

Numeracy

Analyse and interpret numerical performance indicators for workplace reporting related to GMP requirements

Oral Communication

Demonstrate two-way communication including active listening and confirming instructions when explaining GMP requirements to team members

Interact with others

Use appropriate vocabulary, including technical language directly relevant to role

Report GMP performance to relevant personnel using required communication method

Get the work done

Access and use electronic document management systems

Personal hygiene must include:

informing team leader or supervisor of any reportable illnesses

removal of jewellery, including:

rings

watches

bracelets

removal of makeup.