Today's pharmaceutical companies are striving to reduce costs and maximize efficiencies, while simultaneously working to advance
the core business as quickly as possible, and must make decisions on the best way to deploy their limited resources. The job
of an operations manager for a modern pharmaceutical facility includes operating and maintaining outlying building services
and the utilities required to create and sustain on-site manufacturing capabilities, energy management, and essential non-manufacturing
services, such as cleaning, building maintenance, catering, and other ancillary services. Outsourcing some or all of these
services is a proven solution to optimize efficiency.
Outsourcing rather than out-tasking
In out-tasking, pharmaceutical technology and manufacturing companies utilize third-party vendors to carry out various maintenance
tasks on specialized equipment, such as water-for-injection (i.e., stills) or compressors and boilers, while leaving the responsibility
for the quality and scope of the work and the internal documentation in the hands of the client. In contrast, when the operations
and maintenance program includes regular, preventive, and predictive work, as well as corrective tasks and technical support,
then the client is operating under the outsourcing model. In other words, outsourcing involves contracting a whole function,
rather than a specific task. Greater savings and efficiencies are found in outsourcing, rather than out-tasking.
Outsourcing energy services
Implementing highly reliable energy solutions at research and manufacturing facilities is a significant challenge for pharmaceutical
companies. The traditional model has been to run a facility with the company owning, operating, and maintaining all equipment
itself, thus assuming exposure to risk on issues such as equipment durability, fuel volatility, and maintaining the expertise
required to keep the system working properly in-house. Pharmaceutical facilities, however, are increasingly embracing the
The outsourcing service provider can be contracted to operate and maintain complex energy plants and ancillary equipment,
- On-site generation and cogeneration assets
- Steam, hot-water, and chilled-water systems
- Mechanical refrigeration facilities
- HVAC systems
- Electrical systems
- Safety systems
- Plumbing/sanitary systems
- General building maintenance.
After the outsourced service provider has been selected, the client and service provider should agree on a well-defined scope
and clear objectives, which should be captured in a service level agreement (SLA). Using a risk-based approach, the scope
and responsibility of the service provider can be built up over time, which will ensure client satisfaction, specifically
around regulatory compliance. However, it is important that the client does not relinquish all responsibility, as the ultimate
regulatory responsibility lies with the product manufacturer.
Identifying a key subject matter expert to serve as a liaison between the service provider and client will ensure compliance
to quality and regulatory systems. The expert should also design escalation and process flows for change controls and equipment
deviation, which pose the most risk to the pharmaceutical manufacturer. For the service provider, customer satisfaction and
adherence to quality systems in this highly regulated industry are essential.
The client and service provider can develop a performance scorecard that is linked financially to the service agreement contract.
Key performance indicators (KPIs) can include areas such as safe systems of work, system availability, and performance against
schedule. Each line item can be linked to a performance metric, and each metric can be weighted with agreed-upon scoring criteria
that is reviewed and scored on a periodic basis (e.g., monthly, quarterly). Linking the score to contract payments, by withholding
an agreed-upon percentage each quarter, drives performance from the service provider's point of view and ensures client satisfaction.
As the relationship between the service provider and client evolves, or as business expands, it is common to review and adjust
Outsourcing maintenance allows the client to reduce costs without reducing core-business company headcount and, as the pharmaceutical
company becomes the customer of the service provider, to more easily drive change and continuous improvement. Outsourcing
also allows management to focus on developing and manufacturing the product rather than on the non-manufacturing activities
involved in facilities engineering.