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Element 7 - Complying with and improving the quality program

7.1.1 - If a pharmacy doesn’t have any staff, does a person still need to be nominated as having responsibility for QCPP matters?

Yes

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7.2.1 - If a pharmacy doesn’t have any staff, does the person responsible for QCPP matters still need a document that defines the responsibilities?

Yes

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7.3.1 - When the ‘Evidence Required at Assessment’ asks for a procedure, does that procedure need to be a written procedure?

Yes, a written procedure is required. Where a written procedure is not required, the evidence will ask for an explanation only.
The pharmacy may elect to maintain their policies and procedures through an electronic format (for example an intranet), although the pharmacy must ensure employees have access to the relevant policies and procedures to perform their duties and are informed of any amendments to those policies and procedures.

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7.4.1 - There is a requirement that all QCPP materials are maintained.  Does this mean the pages of the QCPP materials should not be used in the working copy of the Operations Manual?

No. The intent is that the QCPP materials are available for the pharmacy to use or refer to. Any updates issued by QCPP shall be placed in the manual at the appropriate places.  If the QCPP disk has been misplaced, no remedial will be raised as the information is still available in the manual.

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7.5.1 - How should the pharmacy demonstrate that it has reviewed all procedures and templates at least annually?

T7B Procedure and Template Review Schedule and Record may be used to record when each element, procedure and template is reviewed. Each element, procedure and template is to be reviewed at least annually to ensure it remains relevant to the pharmacy and has been fully implemented. The Assessor may discuss how the mechanism for recording the review supports the pharmacy’s quality management system. 

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