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Element 14 - Managing staff

14.1.1 - If all staff work regular weekly hours and they are informed of their hours in their T12E Offer of Employment, does the pharmacy still need a written roster?

Yes, a staff roster is mandatory and all mandatory items on T14A Staff Roster need to be included.

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14.1.2 - What evidence is required if there is a change in pharmacy staff member shifts?

The signature of the staff member concerned on the relevant roster is considered acceptable evidence. Refer to T14A for further information.

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14.1.3 - Is it mandatory to have a Leave Policy (P14B) in the operations manual?

Yes. The leave policy is a component of the pharmacy employment conditions and rostering system [Element 14 Action 1] therefore must be included within a pharmacy's the operations manual.
 
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14.3.1 - Does the Performance Review System need to be a formal documented system?

Yes. The Evidence Required at Assessment for Element 14 Action 3 requires compliance with the P14C Conducting a Performance Review procedure. This procedure has mandatory actions that would require a formal, documented review process.

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14.3.2 - At the pharmacy’s first assessment under QCPP, does the pharmacy need to have completed the performance reviews for all staff or just have the system in place ready for the first reviews?

At the pharmacy’s first assessment (this excludes pharmacies returning to QCPP), the pharmacy does not need to have completed all staff reviews. The Assessor is required to see the system that has been implemented including evidence of any documentation requirements.

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14.5.1 - What records are to be stored in the Personnel File?

The requirement of QCPP is that a Personnel File is developed and maintained for each staff member. A typical structure of a personnel file should include the following sections:

  1. Employment details (e.g. application form, CV, signed copy of offer of employment)
  2. Statutory leave forms, leave record
  3. Induction and training records, copies of certificates
  4. Consent forms
  5. Performance reviews
  6. Correspondence
     
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14.5.2 - Do the Personnel Files need to be kept in the pharmacy?

 

There is no QCPP Requirement stating Personnel Files must be kept in the pharmacy; however they must be available for QCPP assessment. Under the heading What You Need To Do, it states that a Personnel File is to be developed and maintained for each staff member and confirm that all personal records related to each staff member are stored in their Personnel File. However, these instructions are advisory and if the pharmacy has an alternative procedure for the storage of these records then it is reasonable to accept this as evidence of meeting the requirements of the standard. Therefore, there must be a Personnel File and it must be available on site for the day of assessment to allow a QCPP Assessor to audit records. 

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

Yes, consistent with Program Rules 13 & 14, QCPP 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 and endorsed assessors are not collecting personal or private information of employees rather seeking evidence to ensure the pharmacies Human Resources systems are operating in accordance with Australian Standard 85000 Quality Care Pharmacy Standard – quality management system for pharmacies in Australia. QCPP and EY operate under strict confidentiality requirements under contractual arrangements with QCPP. 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.

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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