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COMPLETING SELF INSPECTION AUDITS IN THE PHARMACY ASEPTIC UNIT

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European Statement

Patient Safety and Quality Assurance

Author(s)

Louise Byrne

Why was it done?

H/PICs are guidelines of professional practice developed by pharmacists working in aseptic compounding units In Ireland in 2013. Chapter 9 advises that ‘a self -audit programme should be established and conducted in an independent and detailed way by designated trained competent people’. In order to adhere to these guidelines a self-audit of one section of the H/PICs was completed.

What was done?

A self-audit against one chapter of the H/PICs guideline was completed.
Changes were implemented where possible.
Issues were escalated to senior managers where required.

How was it done?

Obtain audit skills.
An audit checklist was prepared and an audit, for the premises and equipment section of the H/PICs guidelines was completed.
Non-conformances were identified and graded.
Corrective and preventative action (CAPA) was put in place where possible.
Major/critical non-conformances were escalated to higher management where necessary.

What has been achieved?

An audit training day was completed in November 2014. Skilled auditors in the laboratory were observed completing self-audits.
A checklist for the premises and equipment section of the H/PICs was prepared and an audit of that chapter was completed in March 2015. There were 32 statements in this chapter and non-conformances of various grades were identified. CAPA was put in place where possible. 9 non-conformances were rectified with internal changes. 10 major/critical non-conformances requiring capital/HR funding were presented to higher management, these were summarised into 4 main risks. Business cases were prepared to support the correction of these risks and a summary was added to the risk register. The remaining non-conformances were classified as minor deficiencies and will be corrected at a later date.

What next?

Self-audit is a useful tool and aids compliance with H/PICs guidelines. It allows the identification of high risk activities and grading non-conformances assists in the prioritisation of process improvement projects. It supports the feedback of performance against recognised guidelines to management. An annual self audit plan will be put in place and a peer audit group within a number of other hospitals has been established.

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