FBPPHM4002 — Prepare and review workplace documentation to support Good Manufacturing Practice requirements

Elements & performance criteria

Performance evidence

• identified workplace documentation requiring development or review using workplace documentation management process
• reviewed and developed workplace documentation, suitable for purpose and audience, including: - ensuring compliance with workplace procedures and GMP requirements - reporting improvements - reviewing and updating existing documentation - developing new documentation - applying documentation control procedures when submitting or amending documents
• accessed and used document management systems
• consulted with relevant stakeholders in the preparation and review process and ensured changes are effectively communicated
• communicated information on documentation requirements to others in the work area, including demonstrating: - two-way communication - active listening - constructive responses to feedback

Knowledge evidence

• workplace procedures and GMP requirements
• types of documentation requiring development or review, including: - procedures - instructions - records
• situations requiring documentation development or review, including: - general review - process change - inspection findings - deviations
• procedures and responsibilities for developing and altering documents, including: - version control - good documentation design and the use of templates - an understanding of system security and access levels
• controls systems, including individual roles and responsibilities
• document authorisation requirements and responsibilities of signatories
• systems for recording and storing data and authorised levels of access to electronic systems
• use of documentation, including documents that can be used as evidence during audit processes
• requirements for completion of workplace documentation

Foundation skills

• Reading: Interpret key information in GMP requirements and workplace procedures Review completed workplace documentation to ensure that GMP requirements are met
• Writing: Prepare training documentation using structure, technical language and format appropriate for purpose and audience
• Oral Communication: Demonstrate two-way communication including active listening and confirming instructions when explaining workplace documentation to team members Use appropriate vocabulary, including technical language directly relevant to role
• Get the work done: Access and use electronic document management systems

Unit content sourced from training.gov.au — © Commonwealth of Australia, licensed under CC BY 4.0. Auditori is not affiliated with the Department of Employment and Workplace Relations.

Questions about assessing FBPPHM4002