FUNDAMENTAL #1: CLEAR DELINEATION OF ROLES, RESPONSIBILITIES, AND EXPECTATIONS
It is alarming how often the root cause of an issue in outsourced services can be traced back to a lack of understanding of
the other party's expectations. The contract giver should, first, carefully evaluate and make full account of what its expectations
are. Things that might be taken as understood in one environment may not be implicit in another setting. Complete disclosure
of precise expectations should be made up front, not revealed as a project progresses (or fails to progress). After all, if
the contract receiver is unaware or uncertain of what is expected, how can it possibly succeed? This fact also underscores
the importance of tailored, understood, and comprehensive agreements and contracts, the scope and granularity of which should
be commensurate with the complexity and risk associated with the tasks to be performed.
A risk assessment exercise encompassing the full list of activities to be performed by the contract organization should be
conducted to identify all potential failure modes. Those activities receiving higher risk ratings should be afforded a greater
deal of attention in the quality agreement or contract. Notification requirements must be clearly spelled out and terms that
might be subject to interpretation should be avoided. For example, circumstances or events that would warrant notification
should be explained, rather than simply including a requirement for notification in the event of a "significant departure."
Even the phrase "having potential to impact safety, integrity, strength, purity, and quality (SISPQ)" could be open to subjective
interpretation.
Having a quality agreement in place does little good if the people doing the actual work are unaware of its content and requirements.
Depending on the criticality of the contracted activities, a mechanism must be put into place to draw attention to and ensure
compliance with quality agreement or contractual requirements that depart from a site's standard operating practices. In very
high-risk operations, this mechanism may translate into having a member of a client staff in the plant to directly oversee
and verify that operations are in compliance with quality and contractual requirements. Alternatively, quality agreement or
contract (e.g., master service agreement) awareness training could be conducted.
In the clinical arena, site initiation activities routinely include some sort of training by the sponsor on the specifics
of the clinical investigation protocol, but orientation activities such as this often are completely dismissed in contract
manufacturing or GMP services settings. Additionally, a clear definition of communication channels, with designation of primary
contacts for various matters or concerns, can facilitate effective communication between parties and prevent the receipt of
contradictory instructions or information. One effective means for delineating these channels would be including a primary
contacts matrix as an attachment to the quality, contract, or service agreement.
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