Pharmaceutical Asset Management & Reliability Services
Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.
Once a manufacturing process is sketched out, the AMR team works with the client’s design team to establish specifications targeted toward improving the reliability, robustness, endurance, and longevity of the assets that will be required to produce the product. CAI also helps our clients identify original equipment manufacturers (OEMs) who may have the best asset solutions for the application. After a purchasing decision has been made, CAI then assists in developing Factory Acceptance Testing (FAT) protocols and checklists and can either participate or lead FAT evolutions.
During commissioning, the AMR team works collaboratively with Commissioning, Qualification, and Validation (CQV) team members by assisting with the following phases:
- Installation Qualification (IQ) – As the equipment is placed in the facility, AMR works alongside CQV to ensure the support systems are connected and performing optimally.
- Operational Qualification (OQ) – Simple troubleshooting during this phase allows for identification and correction of issues by the vendor/OEM. However, more difficult issues, may need the expertise of our AMR Team.
- Performance Qualification (PQ) – AMR can help set minimums that allow for asset aging and anticipating degradation before impacts overall performance is impacted.
Assets need to be managed to maintain their “qualification” performance level over their lifecycle. Assets are often maintained during their useful life per the vendor recommendations, but these do not always consider the specific conditions relative to your specific environment.
CAI’s AMR team helps our clients develop a Strategic Asset Management Plan, in compliance with ISO 55000, that identify how each Asset Class will be maintained throughout its life. These plans include expected life, programmed changes in PM frequencies, critical spare parts, obsolescence, and even redundancy requirements. Training and skill requirements must also be addressed, otherwise properly written SOPs may be rendered useless.
In the last phase of the asset lifecycle, decommissioning, AMR can assist with disconnection, removal, and disposition services and help ensure that minimal operational disruptions exist.