Google Links

Follow the links below to find material targeted to the unit's elements, performance criteria, required skills and knowledge

Elements and Performance Criteria

  1. Maintain quality system documents.
  2. Coordinate quality system practices.
  3. Coordinate audits.
  4. Monitor, review and continuously improve quality systems.

Performance Evidence

Evidence of the ability to complete tasks outlined in elements and performance criteria of this unit in the context of the job role, and:

take responsibility for coordinating all aspects of a pharmacy quality system over a period of two months

monitor operational activities, over this two month period, to ensure two specific policies, and procedures are followed

check that two specific quality assurance monitoring activities are completed according to schedule

develop updates to two policies and two procedures and communicate changes to staff

complete one review of the operations manual and communicate changes to staff

monitor, review and record details of performance against two quality standards and document comprehensive recommendations for improvements to work practices and quality systems

coordinate processes required for one external quality audit.


Knowledge Evidence

Demonstrated knowledge required to complete the tasks outlined in elements and performance criteria of this unit:

roles and responsibilities of quality system coordinator, operational and managerial staff in quality system management processes

format, content and use of:

pharmacy industry quality standards

organisational policies and procedures that align to quality standards

operations manuals

quality assurance monitoring records

staff training records

explanatory instructions for external audits

audit compliance reports

scheduling requirements for quality assurance monitoring activities

methods for communicating quality standards, policies, procedures and quality assurance monitoring activities to staff

record keeping requirements for quality assurance systems

basic principles of evidence based assessment and record keeping

methods of monitoring adherence to quality standards, policies and procedures

external audit processes:

purpose of external audits

role of external auditor

process for preparing and presenting required documents

requirements for and methods of responding to non-compliances identified by audit.