Background Change controls are part of good manufacturing practice (GMP) requirements in industry. The new version of management standard, ISO 9001: 2015, also introduces this concept from organisational aspects; nevertheless, its implementation could be critical in the complex and changing environment of a hospital pharmacy.
Purpose The aim of this work was to design a methodology to implement change controls within our organisation.
Material and methods We first defined what a change is. Then, we set up a group of key resource persons to rank each change and its management. This ranking was rated with a score based on two criteria: impact level for the organisation (maximum score 12) and potential risk caused by the change (maximum score 64). The combination of these scores allowed us to define the level of follow-up needed for each change. If a threshold was met by the combined score, the change was integrated in a centralised monitoring matrix and tracked by the quality officer. If not, the change was considered as minor and was simply tracked internally by each pharmacy unit. The centralised threshold point was set at 17/76 (22% of maximum score).
Results 58 different changes were identified as recurrent throughout the 16 processes of our organisation. 29 types of changes (50%) were already addressed in our quality system: The average total score was 15 (11.25–18.75) for an average impact of 5.7 (4.97–6.43) and an average risk of 9.24 (6.23–12.25). 15 (26%) exceeded the centralised follow-up threshold.
Conclusion These changes monitored centrally were focused on GMP aspects and not all of them were supported by our quality system. Thus this work allowed us to systematise our practice and formalised it through a quantitative indicator. This typology will serve as a reference system for the different units of our hospital pharmacy, helping to harmonise the process of change controls.
References and/or acknowledgements Standard quality management systems–requirements ISO 9001: 2015.
PICS Good Manufacturing Practice Guide PE009-12.
No conflict of interest
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