Quality Roles

Quality representation is very important because the Quality representative is the Subject Matter Expert on Quality. In my experience having a Quality representative who has technical knowledge about the systems being installed is rare. Most Quality representatives assigned to a project team have no real knowledge on how an HVAC system design or a water system design or a bioreactor design is supposed to work. Their knowledge is primarily of cGMPs requirements regarding facilities and production requirements as discussed in 21CFR Parts 210 & 211, or Part 820. 

In 2019, ISPE released a revised Commissioning and Qualification Baseline Guide that is based on a quality risk management-based integrated commissioning and qualification approach using common terminology and methodology. Baseline Guide, Vol. 5, Commissioning and Qualification, defines the role of engineering and quality in this risk-based environment. Engineering is responsible for implementing the risk control strategy—that is, ensuring that critical design elements (CDEs) of the identified system based on the risks assessments are satisfied by the design. Engineering is a key contributor to development of the design qualification (DQ) based on the final approved design. During commissioning and qualification, engineering SMEs develop the commissioning and qualification plan; perform vendor assessments where they could be beneficial; develop, approve, execute, and review verification testing; and manage discrepancies and changes. Engineering personnel/SMEs then develop the acceptance and release reports. 

Under this risk management-based integrated commissioning and qualification model, quality personnel have an oversight role with the following responsibilities: 

• Ensuring that the commissioning and qualification process uses product and process knowledge 
• Ensuring that the critical quality attributes (CQA) and process parameters are incorporated into the user requirements specification 
• Approving the risk assessment, including the identification of critical aspects (CAs) and the acceptability of residual risk 
• Approving the identification of critical design elements and their acceptance criteria 
• Ensuring that testing and documentation are commensurate with risk by approving the commissioning and qualification plan, vendor assessments, verification testing deviations involving critical aspects and design elements, and acceptance and release reports 

Often cGMP-knowledgeable Quality people do not understand the value and skill that an SME possesses when problems arise, and how the Quality role fits into the project execution. As a result, project team conflict can occur and man-hours wasted and project schedules adversely impacted. 

MEDVACON and our team of Quality Experts have conducted several CQV projects, some of which involved multidisciplinary teams and others with just one or a few resources.  MEDVACON can scale to handle your CQV project.