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Element 15 - Ongoing staff training

15.1.1 - This action requires a Training Plan for each staff member”. Does the pharmacy have to produce an individual plan for each staff member or will one plan covering all staff be acceptable?

Where the pharmacy determines that all of the staff has the same training requirements, a single Training Plan for all staff members is acceptable. Similarly, a pharmacy may produce one Training Plan which contains different training requirements for each staff member. This is also acceptable.

Resources

15.2.1 - Can In-Pharmacy Refresher Training be delivered by a pharmacy intern?

Yes. For more information, see Training Requirements for Pharmacy Medicines and Pharmacist Only Medicines for Suggested topics and evidence required at assessment.
Resources

15.2.2 – If a staff member completed a pharmacy assistant course prior to 2002, and the unit/course is not included on the ‘Training Requirements for Pharmacy Medicines and Pharmacist Only Medicines’ brochure, are they required to complete initial S2/S3 training through a Registered Training Organisation?

The initial training requirements, currently require staff to complete a recognised course delivered by a Registered Training Organisation. QCPP acknowledge that pharmacies may have staff that completed a pharmacy assistant course prior to the conception, in 2002, of the recognised units/courses listed in the ‘Training Requirements for Pharmacy Medicines and Pharmacist Only Medicines’ brochure.

If the pharmacy is issued a remedial action against a staff member who completed a pharmacy assistant course prior to 2002, the pharmacy can submit a Remedial Review Request where individual circumstances, such as the staff members pharmacy experience and commitment to ongoing refresher training, will be taken into consideration when determining whether or not a concession will be granted.

QCPP recommend staff members in this situation undertake Recognition of Prior Learning (RPL), a process that acknowledges the skills and competencies gained from work experience, prior training and life experience, in order to obtain evidence of completion of SIRCIND002 Support the supply of Pharmacy Medicines and Pharmacist Only Medicines for future QCPP assessments.

Resources

15.4.1 - Where should staff training records be stored?

Staff training records need to be stored within the pharmacy. Training records can be stored in the Personnel File, Evidence Folder or in a separate filing system such as a Training File or Folder. When a staff member leaves the pharmacy, the training record must be stored in the Personnel File. Resources

The evidence required at assessment sometimes requires the Assessor to sight records for a maximum of five staff. Who chooses which staff member records the Assessor will view?

It is up to the Assessor to decide which staff member records they sight and will choose through a random audit approach. An Assessor may ask for records for a specific staff member when checking compliance.
   
Can I provide a declaration that evidence is stored off site to demonstrate that I am compliant with QCPP?

 No, Your assessor will need to sight evidence the pharmacy is meeting QCPP Requirements consistent with the evidence required by the QCPP Requirements (i.e. blue folder or digital equivalent).

In the event a pharmacy elects to store personnel files off site, the pharmacy will be required to ensure all personnel records are on site for the day of assessment to allow an assessor to randomly audit records.

 Does the assessor need to sight employee files, or does the Privacy Act prevent this from occurring?

 Yes, consistent with Program Rules 13 & 14, assessors are required to view records, including employee files to ensure the Human Resource System is consistent with QCPP requirements and is being utilised accordingly.
QCPP is not collecting personal or private information of employees rather seeking evidence to ensure the pharmacy’s Human Resources systems are operating in accordance with Australian Standard 85000 Quality Care Pharmacy Standard – quality management system for pharmacies in Australia. EY, including their staff and contractors are contractually required by QCPP to maintain confidentiality and privacy. This  should be highlighted to your employees prior to the commencement of every QCPP assessment in the opening meeting. In addition, it is expected Assessors are accompanied and observed by one of your employees at all times and are not accessing records in isolation.
QCPP has sought direct advice from our accrediting body to ensure QCPP is operating within the legislation and requirements of an accreditation body. The Joint Accreditation Scheme for Australia and New Zealand (JASANZ) have confirmed:

 "Certification schemes such as QCPP which include a field assessment as means of evaluating compliance, require the assessor to establish on the basis of objective evidence, that the client organization is employing/engaging appropriately qualified and trained staff to deliver the services that are relevant to the certification. To enable the assessor to draw correct conclusions it is expected that he/she will need to view records.

  The basis of this expectation is found in ISO/IEC 17021-1:2015 Clause 9.4.4.2 which states:

 9.4.4.2  Methods to collect information shall include, but are not limited to:

 a) interviews;
b) observation of processes and activities;
c) review of documentation and records.

 It is a condition of JAS-ANZ accreditation that certification bodies establish and maintain a confidentiality policy and that they require their assessors to sign a formal undertaking to abide by such policy.

 The QCPP certification scheme is operated by the Pharmacy Guild of Australia which is accredited by JAS-ANZ under ISO/IEC Guide 65. The conduct of QCPP field assessments is periodically witnessed by JAS-ANZ in order to verify adherence to Guild policies and procedures and accreditation requirements." 


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