Quality Culture has always been important within pharmaceutical manufacturing operations. Strong companies know this and have invested resources in systems and personnel to support and promote a focus on quality processes, product quality, and meeting patient needs. More recently, health authorities have placed additional emphasis on quality culture by including it in guidance documents and inspection protocols like the PIC/S Data Integrity Guidance, FDA New Inspection Protocol Project (NIPP), and the MHRA Data Integrity Guideline.
Both ISPE and PDA have developed information and resources to help pharmaceutical companies better understand why quality culture is important and how to assess the current situation within a site or organization. The ISPE Cultural Excellence Report shares the vision of quality culture improvements across six dimensions, utilizes a 19-behavior cultural maturity assessment, outlines a series of practices and tools to support implementation, and provides a practical frame of reference for companies that want to build healthy quality cultures within their organizations.
The PDA Quality Culture Assessment Program is based on a Maturity Model containing 21 quality culture metrics and offers training for assessors, a PDA-administered all employee survey, and access to composite benchmarking results for comparison with peer sites.
By using either approach, a company can identify and prioritize areas within their own culture that need improvement. Many companies have specific cultural and quality system assessment processes which they have developed internally and would benefit from the use of a reference guide to advance the maturity of a specific framework element. Members of the ISPE and PDA culture task forces have come together to develop this reference guide that identifies specific aspects of quality systems and culture and recommendations for tools, techniques, and processes.
The purpose of this guide is not to provide complete training or implementation of any tools or to be an all-inclusive list; instead, the guide is intended to serve as a resource with links to additional information for the most commonly used tools. The tools included in this reference guide are accessible without fee. Different approaches or tools may be better suited for some problems or situations, and it is up to each user of this guide to determine what works best in each circumstance. The guidance is divided into two sections: “Root Cause Analysis Tools and Approaches” and “Human Error Analysis Tools and Approaches.”
Read also: Introduction to ISPE GAMP 5 Guide
