The Partnership Between Biosafety and Quality: Work Smarter, Not Harder!
By Kristina Peterman, RBP, Senior Scientist
You may wonder what the relationship is between biosafety and quality. Does the relationship exist in environments outside of production and manufacturing, such as in academic and research environments? Can a partnership be developed between biosafety and quality?
The answer to both of those questions is YES!
Biosafety and quality programs have a similar goal: to produce a quality product safely. The product for academia and research is the documentation to support the work that was performed safely. It would be great to take advantage of the potential for partnership between biosafety and quality and pool our resources to fortify our castle! Organizations often view biosafety and quality programs as requirements, standards, and guidelines that need to be implemented by separate teams. Usually, they receive attention only when the regulatory or accrediting body is involved. These programs are complementary, however, and a partnership can lead to the application of biosafety for personnel and the work environment, generating inherent quality in the products produced.
The application of biosafety through techniques, knowledge sharing, and equipment is communicated to personnel through documents and training. The development of these documents can leverage an organization’s current quality systems by using standard templates (even for research notebooks), writing techniques, document reviews, approvals, and training requirements that are already in place. The work is already half done—we can work smarter, not harder. Corporate biosafety and safety plans and policies could be included as part of an overall quality management system.
Advantages gained by the biosafety and quality partnership are:
- One system for documentation
- Ease of locating biosafety documents
- Up-to-date documentation through required document reviews and retention policies
- Incorporation of biosafety and safety requirements and references within the documentation
- Communication of documentation changes to impacted personnel
- Tracked training on documents
- Biosafety equipment is maintained following quality requirements for preventative maintenance and calibration
Quality programs gain a perspective on biosafety that they can apply through the partnership with biosafety programs. Quality auditors can now audit laboratories and the work environment through two lenses—quality and biosafety—due to the knowledge gained through the documentation, equipment, and requirements currently incorporated into the quality management system. Biosafety risks identified by auditors may prevent quality issues for the products produced.
So, what are the first steps you can take to realize this partnership?
- Determine what the product is you are producing—is it a physical object or research?
- Determine the quality and biosafety that is needed for this product—a quality product or well written and documented research?
- Find out if there are existing quality and biosafety standards in place. Are these organizational, research, or compliance requirements?
- Reach out! Ask questions to groups such as biosafety, safety, intellectual property, grants, and contracts. What level of quality are they expecting?
Taking advantage of the biosafety and quality partnership can lead to a quality work environment with an inherent culture of biosafety.