“Standardization is our friend.” Beth Staub, vice president of quality and regulatory affairs of Stryker Corp., offered these words of advice at HealthPack during her opening keynote. Focusing her talk on “lessons learned,” Staub outlined Stryker’s ongoing companywide reorganization of its packaging functions and the importance of a common packaging philosophy.
Stryker manufactures thousands of SKUs that consist of high-value products in small lots. “Orthopedic products are like shoes—there are several sizes,” Staub told the audience. With seven company divisions divided into 22 sites, “everyone did things their own way.”
When Stryker decided to move to a common corporate quality system, it found that “packaging was the greatest source of commonality,” she explained. But “we saw issues with packaging that could have been avoided.”
Staub consulted with medical packaging industry veterans Curt Larsen and John Spitzley of Spartan Design Group. “They suggested drafting ‘should-be templates and protocols’ that could be used by all sites,” she recounts. “They helped us see that a packaging system is a three-legged stool dependent upon manufacturing/process validation, package design, and stability testing.”
Staub summed up some of the key packaging lessons that Stryker learned as follows:
• A common packaging vocabulary is key. For instance, the term validation is overused and misused.
• Old habits die hard. For instance, it is not necessary to age packaging with a product, regardless of how aging was conducted in the past. Less testing is supported by guidance. But it takes confidence to eliminate testing.
• Even the best packaging engineer needs a statistician. Everyone wants to know, “How many samples do I test?” But one size—i.e., one sample size—does not fit all. A common risk-based approach is necessary for audits to go smoothly.
• Standardization is our friend. It reduces risk and redundant improvement activity, and we won’t have to do the same work over and over again.
• Remember the customer, especially when it comes to opening and waste issues.
• Design controls for packaging should mirror those for medical devices. Packaging is getting the same regulatory scrutiny as products.
• Expertise and oversight are needed. Avoid grandfathering, waivers, concessions, or deviations from procedures.
Staub found that her colleagues welcomed standardization. “I don’t have to figure it out by myself,” she heard, almost as a sigh of relief. Standardization minimizes costs and risks, she added.
Working at developing common packaging approaches for two years now, Stryker’s path forward is to solidify minimum requirements and develop common vocabulary and quality systems. Best practices will be shared through templates. “A harmonized common approach is the right way to go,” she said.
On behalf of PMP News, I asked Staub after her keynote whether anyone was afraid to make these changes because doing so could have been seen as an admission of problems that required recalls. “Everyone was meeting requirements,” she answered. “We took a harmonized approach to developing a safety net for the future. If we had found problems, we would have recalled products.”
PMP News will be sharing more articles on HealthPack 2009, including the exclusive and ever-popular nurses’ survey and panel discussion which gave attendees eye-opening feedback on packaging, in its upcoming April issue as well as in future blogs and newsletters. Check back at www.pmpnews.com/blog shortly!
For details on HealthPack 2010, which will be held March 2-4, 2010, in San Antonio and will feature even more input from nurses, visit www.healthpack.net.