Element 17 - Maintaining safety and security

17.1.1 - Does a pharmacy need to have all Element 17 procedures in place?

The pharmacy needs to consider and evaluate their own practices, as well as state and federal legislation, to identify the relevant procedures they require - hence the pharmacy will need to undertake a risk analysis.
If the pharmacy confirms a potential risk and therefore requires a relevant procedure, they must comply with all mandatory steps within the procedure.


17.2.1 - Does a pharmacy need to display the T17C Bag Inspection Sign at the entrance to the pharmacy?

Yes. If the pharmacy conducts bag inspections, then a bag inspection sign is mandatory.


17.3.1 - Is a pharmacy required to have a safe lifting wall chart on display?

The pharmacy needs to consider and evaluate their own practices, as well as state and federal legislation, to determine for themselves whether they require a Manual Handling Procedure.

If the pharmacy proprietor or manager decides the pharmacy requires a Manual Handling procedure, then that procedure must be compliant with the mandatory requirements of P17O Manual Handling.
P17O Manual Handling Action 11 (mandatory) requires a T17E Safe Lifting Wall Chart.
T17E Safe Lifting Wall Chart states, 'This sign must be A4 size at a minimum and be displayed in the storage area'.


17.4.1 - What is a current first aid qualification?

The first aid qualification is to be the “Senior First Aid” certificate and should be current as per the accredited training provider’s guidelines (usually renewed every three years).
There is no requirement for the staff member to do the CPR competency every year.  It may be done at the time of the triennial renewal.


17.4.2 - Does a non-pharmacist staff member with a current first-aid certificate meet the requirement of Element 17 Action 4?


17.4.3 - What evidence is required as proof of having a Mental Health First Aid qualification?

A Mental Health First Aid certificate. This is issued once a person has completed an accredited Mental Health First Aid course, provided by a Registered Training Organisation.

17.5.1 - Do State legislative requirements for the testing of electrical equipment have any impact on assessing how pharmacies test their safety systems?

The Assessor will need to see the completed T17F Testing Safety Systems Schedule and ensure it is being completed in accordance with whatever frequency the pharmacy has on the form and by whomever the pharmacy deems able to do the testing. State legislative requirements may be above and beyond QCPP requirements.


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 which states:  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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