In light of the challenges associated with building a quality culture and measuring progress amid the varying environments in a pharmaceutical organization, PDA Quality Culture team has developed an assessment tool specific to the pharma industry that can be used for internal assessment as well as audits of pharmaceutical suppliers and contract manufacturing organizations.
Though much has been published on the subject of quality culture, there has been little information on how to quantitatively measure it. PDA has taken the initiative to change that. According to PDA, “The tool aims to be simple, objective and verifiable so that subjectivity during assessment can be minimized. We are seeking twenty manufacturing sites as pilot participants that can help us test out the toolstarting Aprilthis year.”
PDA released the following Q&A about the pilot:
Why should I participate in the pilot?
Quality culture is critical to an organization but very hard to measure. PDA’s tool aims to assess quality culture in an objective way and the tool itself serve as a roadmap for improving quality culture.
What will I get out of the pilot?
Quality culture maturity level of your site and benchmarking data with industry peers.
What resources do I need to participate in the pilot?
The pilot will require a rough estimate of 2 to 3 auditors for 80 hours total in the span of 6 months, plus all site employee survey, which requires at most 30 minutes to take. In addition, meeting with management might be needed depending on the level of engagement of the firm.
Who will perform data analysis?
PDA will perform data analysis so data will remain anonymous to industry.