Procurement Citations.

We have been inundated with queries and comments regarding our last newsletter.  The basic undertone from these queries and comments was; incredulity as how we could develop such a complete User Requirements Specification (URS).  These remarks tend to substantiate a FDA comment that perhaps up to 75% of validation citations could be attributed to; a complete lack of, or poorly documented procurement procedures.

All reviewing regulators are expecting and inspecting to verify that all predicate activities are executed in accordance with documented company approved procedures.   Raising a URS is one such activity. 

The validation manager (or the person identified in the quality system as responsible for all validation activities) is required to ensure that company approved procurement procedures are available and used by all personnel involved in procurement activities.  All parties; engineering, production, procurement, human resources, quality control and assurance, must sign-off a check-sheet detailing all aspects of this validation task have been considered.

Failure to ensure that all purchased or otherwise received product and services conform to specified requirements; and failure to implement written purchasing control procedures, as required by 21 CFR 820.50.

Specifically, you have not established requirements, including quality requirements that must be met by your suppliers and contract manufacturers; and have not documented your evaluation of suppliers and contract manufacturers.  (FDA archives)

A project we were brought in to expedite was found to be derelict in not requesting or investigating;

Ø  As built drawings.

Ø  Calibration standards (nuclear).

Ø  Quality Steam & Water system. s (insufficient capacity).

Ø  HVAC system (Room airflows needed to increase drastically).

These four items delayed the handover of the project for twelve months and doubled the cost.      

Combination IQ/OQ/PQ Protocol.
This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand-alone equipment. It is an interactive, fully detailed, sixty three page protocol that runs to approximately seven thousand words. It is presented in 'MS Word' to facilitate ease of final editing by the end user. It has become a very popular document.