Maintenance/ Calibration Program Assessment – Compliance Risks & Operation Improvements

Maintenance/ Calibration Program Assessment – Compliance Risks & Operation Improvements

The Challenge

A major pharmaceutical manufacturer in northern Texas requested PCI assess their maintenance and calibration programs. The assessment targeted the processes for equipment induction into the plant and change management program while focusing on the front end work request and close out process.  The result was a well-defined program enabling plant operations to move towards a paperless process.

The Solution

A detailed gap analysis of their business processes for maintenance and calibration programs were performed.  The analysis included the areas of equipment criticality classification, identification of critical spare parts inventories associated with PM activities, equipment hierarchies within the CMMS systems, preventive and corrective maintenance procedures, overall maintenance program compliance, and best in class requirements improvements were identified.

The solution included the following programs and processes:

  • A standard Measurement Data Template was established for all equipment/ instruments in Blue Mountain Regulatory Asset Manager (RAM).
  • Changes to “out of tolerance” and reverse traceability processes.
  • Implemented a new process for managing 3rd party vendors and associated documentation.
  • Developed reports to print PMs with parent/ child hierarchies for any selected parent.
  • Configured e-signatures within RAM software for equipment/instrument induction.
  • Developed and implemented validated reports within RAM.
  • Identification and creation of critical spares associated with equipment/ instruments in RAM.
  • Implementation of an end-to-end paperless process for maintenance and calibration activites.

The Result

  • Calibration vendors are pre-qualified through consistent audits.
  • Reduced cost of implementation through the use of PCI’s quality approach.
  • Training directly implemented calibration workflows.
  • Compliant calibration and maintenance programs that clearly display evidence of control in FDA and client audits.

The Benefits

Benefits to the client include:

  • Calibration program policies and executable calibration procedures are shared across sites.
  • Calibration vendors are pre-qualified through consistent audits, and the audit findings are shared across sites.
  • Compliance Risk were identified and eliminated or significantly reduced.
  • Operational efficiencies were gained by moving into paperless environment.


For additional information, contact:
Consultant Services Team