Do you know how to navigate conflicting guidelines and defend your decision in front of multiple inspection agencies?

Vipsit has over the years developed a systematic approach to compliance with regulatory guidelines. It is worth the effort to identify them all in advance and to find the synergies and clashes before any serious design work will start. It is not just worth the effort, it is a necessary effort. The guidelines are the foundation upon which the whole project rests. Even if international experts are brought in, they might not be experts with regard to the national regulatory documents.

We have supported companies in up front identifying all relevant guidelines (it is sad if ian extra guideline suddenly surfaces half way through the project), and have created a methodology to hash out conflicting requirements from GMP, Environmental, Biorisk management guidelines, and institutional policies blended with relevant ISO / EN standards. We have created an overview of where these guidelines have unique requirements that do not conflict with others and where conflicts will arise. This gives the institution an opportunity to bring up the conflicting aspects early and decide how to address them.

Regulatory compliance is where it begins to get serious. The inspectors first impression is important, the confidence from the staff during the inspection cannot be over estimated, all fills into the perception and opinion when the inspectors are leaving.

We have rarely seen a facility or an institution that was required to adhere to only one set of rules. Most often, there are many masters to serve. It can be challenging to convince one set of inspectors that other regulating bodies also have reasonable requirements.

Most inspectors are reasonable when evidence is presented that another driver from another guideline “won” this contest, and that the intent behind the requirement in dispute has been met, just in a non-traditional way.

Just as Vipsit does not work with finalized, prefabricated checklists, we do not have a giga database with all of the published guidelines to pull out of our drawer. But we are willing to work with you and to do the hard analytical work together with you, just in case you do not have your own internal resources for this type of work.

COMPLIANCE ASSESSMENTS

Vipsit can assist with gap analyses for compliance with specific standards and guidelines. We have developed several tools to facilitate the process and track it as it occurs.

Vipsit performs facility compliance assessments from a performance and procedural perspective. A facility assessment is a snapshot in time. It documents where the facility is right now in relation to a certain set of guidelines.

Vipsit does not perform assessments of engineering and architectural structures … but we know those who do and can guide you.

Facility and laboratory assessments are the cornerstones when it comes to risk assessments, guideline compliance and facility design. 

When our clients ask us to perform or facilitate a laboratory assessment, we typically get the request: “One lab assessment please!”

That is when the dialogue starts…., not where it ends. Our next questions will be:

1. When?
2. What type of assessment? 
   1. The whole facility? or just one laboratory?
   2. Environmental impact? Dangerous for the surrounding human and animal community? 
   3. Biological/chemical/radiological safety? Safe workplace for your staff?
   4. Security? Safe from adversaries and intruders that want to do harm?
      1. Do you hold biological agents of concern?
      2. Do you hold chemicals that can be used as pre-cursors for chemical warfare agents?
      3. Do you utilize dual-use equipment and material that are of concern, and where it would be preferable that this did not get in the wrong hands?
3. How deep an assessment?
   1. Do you want a list of observations?
   2. Do you want the observations listed in order of concern and identified risk drivers?
   3. Do you want a first stab of an evaluation of what is acceptable and what is not, for your management to start from?
   4. Do you want a suggested list of mitigation measures sorted out in a logical order according to the traditional view of “hierarchy of controls”?
   5. Do you want the mitigation measures listed with pros and cons, and an impact assessment of interactions your other systems?
   6. Do you want us to work with your facility during the implementation phase, keeping an eye on progress, milestones, and final performance verification?
   7. Do you want us to write up a risk mitigation rationale report, documenting the facility reasoning for the cut-off?
4. Do you want the report
   1. With observations in a table format?
   2. With pictures from the walk-through as illustrations?
   3. As a formal write-up with references to specific requirements in specific guidelines?
   4. With your facility drawings embedded and indicators on the drawings where the observations were noted?
5. What is your timeline for the final deliverable?

We will then come to your site, work with your staff and deliver a report with observations.

Several members of the Vipsit group work as recognized reviewers for international scientific journals. We serve on standards committees, revise guidelines, and define the future requirements for our industry.

PERFORMANCE VERSUS PRESCRIPTIVE

Most modern standards are performance related instead of prescriptive and they rely on facility and process related risk assessments performed by the user and documented accordingly. It is expected that rigid and thorough risk assessments are performed by the facilities themselves and serve as a foundation for the chosen risk mitigation strategies.