Risk documentation and communication
The outputs of this risk-management effort comprise the documented justification for controlled revisions to:
- Training and qualification curricula for personnel initiating change controls where functional-equivalence will be assessed
- Equipment change control standard operating procedures that direct the functional-equivalence assessment process for parts
- Maintenance-systems inventory process-control flow.
Training is required to be performed on these updated documents and training records are periodically audited for compliance.
As part of the firm's standard practice for the ongoing maintenance of quality systems, routine audits and document reviews
are performed throughout each of the quality systems impacted by this risk assessment (i.e., training, change control, and
equipment maintenance). Adverse findings or trends identified during these reviews would provide indication whether the risk
assessment needs to be revised.
Ted Frank is with Merck & Co; Stephen Brooks, Kristin Murray,* and Steve Reich are with Pfizer; Ed Sanchez is with Johnson & Johnson; Brian Hasselbalch is with the FDA Center for Drug Evaluation and Research; Kwame Obeng is with Bristol Myers Squibb; and Richard Creekmore is with AstraZeneca.
NOTE: In assembling this collection of case studies, the authors recognized the benefit of providing industry with additional
background on core risk methodologies. Training tools for the application of risk ranking and filtering, FMEA, FTA, and HAZOP
are available online with the web version of this article at
http://PharmTech.com/PQRIstudies. These tools are meant to facilitate greater familiarity with the risk methodology used in each corresponding case study.
*To whom all correspondence should be addressed, at email@example.com
1. T. Frank et al., Pharm. Technol.
35 (7), pp. 72–79.