Tyco Healthcare/Mallinckrodt Regulatory Compliance and Process Audits 

Pangea Group was retained by Tyco Healthcare/ Mallinckrodt to perform a series of regulatory compliance and process audits at their Medical Imaging Research facility in Hazelwood, Missouri, and Nuclear Medicine Isotope Production facility in Maryland Heights, Missouri.

Audits were performed of the Radiation Protection Programs, Corrective Action Programs, and various production processes over a 5-month period in 2001-2002.  As part of the scope of work, Pangea developed a series of audit checklists that were then used as the basis for the audits at the facilities.  The checklists included regulatory criteria including Nuclear Regulatory Commission’s Standards for Protection Against Radiation, 10 CFR 20, and best management practices. 

As part of the audits, Pangea personnel observed various production processes, reviewed applicable Standard Operating Procedures and Standard Testing Methods, and interviewed facility staff, and inspected facility records.  The facilities included in the scope of these audits handle many different radioisotopes, some of which are handled in very high activities.  Consequently, the operations posed significant potential for external radiation dose to workers.  Pangea’s findings and recommendations were ultimately used to improve worker safety and reduce liability exposure from potential regulatory and legal actions.

Audit reports were completed for each individual audit, allowing for review and comment by the client prior to final issuance.  In addition, the reports were organized to list findings (regulatory compliance matters) and recommendations (best management practices) separately.  All findings and recommendations were prioritized to assist facility management personnel in assigning corrective action dates.

The client was very satisfied with the quality of the audits and the timeliness of the reports, which resulted in the opportunity for repeat business with this client.