On-Site Assessment & Report Card


1. What is Valutek OSARC program?


The on-site assessment is conducted by Greg Heiland, Valutek CEO, published author contamination control. His curriculum vita highlights his pertinent experience since 1982.

The assessment will document your actual operating state, in comparison with:


- Internal S.O.P. / cG.M.P.


- Industry “best practices” for a comparable ISO facility


The deliverable Report Card identifies the GAPS in your contamination control actual practices versus your internal SOP. Passing a C.E.T.A. (Controlled Environment Testing Association) certification just means that your site meets the minimum requirements. The difference between your mandatory requirements, and best practice recommendations is a leading indicator of your sites future risk of a non-compliant event.


Based on N.E.B.B. (National Environmental Building Bureau), over 70% of the contamination in your facility is the direct result of operator behaviours. The independent assessment can help you identify and reduce the risk of operator behavior contributing to a non-compliant event.


The On-Site Assessment is perfect for facilities where the stable state of the controlled environment has a direct impact on your organization overall success.



2. Who is eligible for an On-Site Assessment?


All active Valutek contracted clients will qualify for an annual On-Site Assessment with over 100 Operators.



3. What is the coverage scope of the On-Site Assessment?


* Cleaning protocols:

- Facility / environment cleaning

- Critical “product contact” cleaning


* Gowning Room best practices

- Operator flow

- Hygiene requirements / accountability testing


* Production area

- Foreign material identification

- Preventing “unintended consequences” which lead to potential contamination events


4. What are the On-Site Assessment Deliverables?


The “deliverable” is a “Report Card” which benchmarks your facility against other FDA regulated Medical Device Manufacturers operating a similar facility.

The “Report Card” are best practice recommendations based on our experience of working directly with leading high technology firms since 1988. Valutek has conducted On-Site Assessments for leading organizations in Academia, Advanced Materials, and Life Sciences.

The goal is to help your firm have a risk management tool to help your organization build fault-tolerance, and redundancy into your controlled environment operating procedures, and their execution.

The outcome is higher yields, less re-work, and improve the culture where the operators understand the potential disastrous outcomes if protocols are not followed.


As an independent party, Valutek can partner with your technical / quality team to provide additional resources, and support to validate best practices.

In addition, thru our affiliation with GSFFC, we can sponsor independent testing of your consumable materials (gloves, wipers, and apparel). This testing expense underwritten by Valutek to help your technical / quality team understand the specific performance capabilities, and limitations of your consumable materials.




5. HOW CAN I APPLY?


The On-Site Assessment is coordinated thru your dedicated Account Executive. An NDA is executed prior to the on-site audit.


Please submit the following form: