Communicate Packaging Criteria to Avoid Risk

Success also depends upon clear communication between partners, emphasized Lora Keena, vice president, quality assurance and regulatory affairs, for Oliver-Tolas Healthcare Packaging (Grand Rapids, MI). Keena spoke at MD&M West 2009's preshow packaging conference. "It is important to gain a thorough understanding of expectations through due diligence before projects begin," she said. "This includes performing risk assessments so both parties can anticipate potential failures before they occur."

Needs, expectations, limitations, and risk should be evaluated, documented, and agreed upon. "Critical in establishing customer and supplier synergy is knowing who will perform tests and when, how results will be documented and what path will be taken in the event of failure," she explained.

Keena cautioned against using vague terms such as 'good' or 'acceptable' in documentation. "There should be a measurable result."

Understanding risk is crucial, Keena explained. Not only is personal and criminal liability at stake, but also company reputation and brand success. It is clear that market recalls need to be avoided, however even internal failures can cost time and money. For instance, "what if the competition releases its product two months before you do?" she asked. To watch Keena discuss risk assessment at MD&M West, click here.

A carefully selected team can help ensure proper communication. Representatives from both the manufacturer and supplier must be present as well as professionals from engineering, manufacturing, the laboratory, and QA/QC. "Additionally, you should include an unbiased person who can ask questions," she suggested.

Goals and objectives should be thoroughly reviewed, and all efforts should be harmonized—including test methods, terminology, sample sizes, equipment, and more. "There should be agreement on defect definitions and acceptance criteria," she said.

Keena also emphasized the importance of test method continuity. Using the example of the same model tensile tester installed in both an engineering lab and in a QC lab, she demonstrated how different sensitivities set by the testing equipment manufacturer were yielding different results. Had the two labs not communicated, materials may have passed in one but failed in the other. "You have to perform foundational calibrations—it is one of the first things to check."


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