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Unit of competency details

SIRCCPM002 - Coordinate a pharmacy quality system (Release 1)

Summary

Usage recommendation:
Current
Mapping:
MappingNotesDate
Supersedes SIRCQUA401 - Coordinate a pharmacy quality systemNot equivalent. Updated to meet Standards for Training Packages. • Competency Field changed to Community Pharmacy Management to better reflect intent of the unit. •Significant changes to Elements and Performance Criteria to clarify content. •Changed knowledge requirements in relation to: o quality system documentation o scheduling requirements o communication methods o evidence based assessment and record keeping o monitoring methods. 30/Mar/2016

Release Status:
Current
Releases:
ReleaseRelease date
1 1 (this release) 31/Mar/2016


Training packages that include this unit

Classifications

SchemeCodeClassification value
ASCED Module/Unit of Competency Field of Education Identifier 080317 Quality Management  

Classification history

SchemeCodeClassification valueStart dateEnd date
ASCED Module/Unit of Competency Field of Education Identifier 080317 Quality Management  09/Aug/2016 
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Unit Of competency

Modification History

Not applicable.

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.

Pre-requisite Unit

Nil

Competency Field

Community Pharmacy Management

Unit Sector

Community Pharmacy

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.

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.

Unit Mapping Information

No equivalent unit.

Links

Companion Volume implementation guides are found in VETNet - https://vetnet.education.gov.au/Pages/TrainingDocs.aspx?q=ca051b1b-5101-4ec2-ac1c-49699303188d

 

Assessment requirements

Modification History

Not applicable.

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.

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.

Links

Companion Volume implementation guides are found in VETNet - https://vetnet.education.gov.au/Pages/TrainingDocs.aspx?q=ca051b1b-5101-4ec2-ac1c-49699303188d