Subject Matter Experts (SMEs):
Subject Matter Experts are defined as those individuals with specific expertise in a particular area or field.
SME responsibilities include planning and defining verification strategies, defining acceptance criteria, selection of appropriate test methods and execution of verification tests using different vendors and reviewing results.
Use of Vendor Documentation:
Vendor documentation, including test documents may be used as part of the verification documentation provided the user or SME has assessed the vendor, and has evidence of:
An acceptable vendor quality system
Vendor technical capability
Vendor application of GEP
If inadequacies are found in the vendors’ quality systems, technical capability, or application of GEP, then the user or SME may choose to mitigate potential risks by applying specific, targeted, additional verification checks or other controls rather than simply repeating vendor activities and replicating vendor documentation.
The decision and justification to use vendor’s documentation to support the verification of CQAs, should be based on the intended use of the manufacturing element, and should be documented and approved by SMEs and quality unit.
Quality by Design (QbD):
To ensure that quality attributes and requirements are designed-in during the specification and design process. Pre tender meeting of prospective vendors are important to inculcate user requirements and expected quality attributes.
Assurance that all systems are fit for purpose and not relying solely on verification after installation, but be achieved by a planned and structured verification approach applied throughout the systems life cycle.
Verification Review:
All completed verification documentation should be reviewed by suitable qualified and independent SME(S), who did not execute the verification tests.
The reviewers should ensure that all tests have been completed and appropriately documented.
Departures and deviations from verification plans should be discussed and resolved by the reviewer and/or SMEs.
Acceptance and release:
SMEs should confirm that manufacturing system is fit for intended use and such confirmation should be documented.
Such documentation should include a review or overview of the results, and a review of any non-compliance of critical aspects. The person/s involved in making this determination should be identified and documented.
Such documentation should be prepared and approved by SMEs, and be approved by the quality unit.
Following the approvals, the manufacturing systems may be released for operational use.
Be Aware:
Understanding of the product, process, manufacturing steps and facilities is critical.
Early agreement between Management, Engineering, Quality & other stake holders is essential before moving in new direction.
Clear understanding of Engineering Documentation is required.
Identification of SMEs is of utmost importance.