Application
This unit describes the performance outcomes, skills and knowledge required to implement a predetermined pharmacy quality system. It requires the ability to maintain organisational policies, procedures, operations manuals and other quality system records; communicate requirements to pharmacy staff and ensure their participation. It covers coordinating external audits, monitoring and reviewing system effectiveness and making recommendations for improvement. Quality standards can be internal or those for a quality program such as the Quality Care Pharmacy Program (QCPP).
This unit applies to senior pharmacy and dispensary assistants working in community pharmacies whose quality activities are supervised by a pharmacy manager or pharmacist. In this context, they work with some independence and lead and guide other team members in quality activities.
No occupational licensing, certification or specific legislative requirements apply to this unit at the time of publication.
Elements and Performance Criteria
ELEMENTS | PERFORMANCE CRITERIA |
Elements describe the essential outcomes. | Performance criteria describe the performance needed to demonstrate achievement of the element. |
1. Maintain quality system documents. | 1.1.Interpret quality standards and evaluate current policies and procedures for compliance and utility to the business. 1.2.Review and update pharmacy operations manual regularly and maintain records of reviews. 1.3.Develop and maintain accurate and complete records of quality assurance monitoring activities. 1.4.Maintain current and accurate training records for staff. 1.5.Report deficiencies in policies, procedures, manuals and record keeping systems to pharmacy manager. 1.6.Obtain approval and modify documentation according to organisation procedures. |
2. Coordinate quality system practices. | 2.1.Communicate quality standards, policies, procedures and quality assurance monitoring activities to staff. 2.2.Confirm understanding, and encourage and support staff participation in quality practices. 2.3.Arrange mentoring, coaching and training to support adherence to standards and quality practices. 2.4.Monitor operational activities to ensure policies and procedures are followed and quality standards are maintained. 2.5.Check regular quality assurance monitoring activities are completed according to schedules. 2.6.Assess and report adherence to quality standards. |
3. Coordinate audits. | 3.1.Prepare documentation for cyclical external quality audits. 3.2.Participate in quality audits and provide assistance to assessors. 3.3.Coordinate and report on remedial actions required by external audits within designated deadlines. |
4. Monitor, review and continuously improve quality systems. | 4.1.Monitor and review performance against quality standards and identify areas for improvement. 4.2.Discuss issues and challenges with operational and managerial staff and seek feedback on quality systems. 4.3.Evaluate information and develop ideas for improvement based on feedback received. 4.4.Report potential improvements to work practices and quality systems and seek approval. 4.5.Implement approved changes and communicate new policies, procedures and quality assurance monitoring activities to staff. |
Evidence of Performance
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.
Evidence of Knowledge
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.
Assessment Conditions
Skills must be demonstrated in a pharmacy with designated front of pharmacy, dispensary and administration areas. This can be:
an industry workplace
a simulated industry environment.
Assessment must ensure use of:
information technology hardware and software
online information systems
pharmacy industry quality standards; these can be:
organisation specific standards used by a pharmacy; or
those for a pharmacy industry quality program such as the Quality Care Pharmacy Program (QCPP)
explanatory instructions for external audits
the following documents:
a suite of organisational policies and procedures that align to the quality standards
an operations manual
quality assurance monitoring records
staff training records
audit compliance reports
schedules for quality assurance monitoring activities
community pharmacy staff with whom the individual can interact; these can be:
staff in an industry workplace; or
individuals who participate in role plays or simulated activities, set up for the purpose of assessment, in a simulated industry environment operated within a training organisation.
Assessors must satisfy the Standards for Registered Training Organisation’s requirements for assessors, and:
have worked in the pharmacy sector for at least two years.
Foundation Skills
Foundation skills essential to performance in this unit, but not explicit in the performance criteria are listed here, along with a brief context statement. | |
Reading skills to: | interpret complex documents including quality standards, instructions for external audits and audit compliance reports. |
Writing skills to: | develop and maintain complex documents including policies and procedures, reports on potential work practice improvements, evidence based documents for quality audits and audit report responses providing clear evidence of remedial actions. |
Technology skills to: | produce and file quality system documents and use online information systems. |
Sectors
Community Pharmacy
Competency Field
Community Pharmacy Management