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No matter what type of packaging you do, whether it be putting pills in bottles or syringes into trays, chances are most of you are scared of the word 'recall.'

But an extremely simple new tool unveiled at this week's WestPack conference in Anaheim, CA, might allow packagers to eliminate any possibility of the dreaded 'r' word. The risk assessment program for sterile packaging, created by an interdisciplinary team of industry professionals, was unveiled by Hal Miller, industry consultant and president of PACE Solutions LLC. "Every packager's goal is to have zero recalls," said Miller. "This gives you a tool to accomplish that."

The program utilizes a series of packaging risk surveys to gather accurate data on various categories. Pages are composed of simple statements or questions for each category, with checked boxes to indicate degree of compliance with quality control steps. Compliance data is scored from 0-4 (with zero indicating no changes needed and 4 indicating more work necessary). For example, a statement in one of the sections reads, "Primary packaging materials and components have documented specifications." Those taking the survey would mark 0 for "Always," 1 for "Most of the Time," 2 for "Sometimes," 3 for "Infrequently," and 4 for "Not At All."

Miller added that any score greater than 0 will need attention or corrective action, and he stressed that the method will force compliance and dramatically reduce recalls. "This is especially important for suppliers," said Miller. "Do your suppliers know their processes well enough? This gives you a way to make sure they do."

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Miller stressed the importance of performing a risk assessment for companies to determine if they meet the minimum essential requirements. By tracking and analyzing recall root causes to determine the areas most susceptible to risk, he suggested that manufacturers could improve recall rates.

According to Miller, the root causes of sterile package recalls fall into four main categories: material causes, including qualification and supplier quality; people, including systems and training; package, including design and testing; and process, including equipment, validations, and control. Each of these categories should be evaluated for risk levels, said Miller. "The end result will be a well-defined path to moving beyond compliance and zero recalls," he said. Risk assessment, he said, should involve a team approach with participation from package development, procurement and supplier quality, engineering and equipment maintenance, and manufacturing operations.

The categories happen to be virtually the same as the root causes of recalls: material qualification, supplier quality, package design and testing, equipment and systems, and process design and control.

Exploring the risk assessment method ensures documentation of procedures, as well as validation of test methods, according to Miller. It can also be a way of routinely monitoring and recording process parameters, documenting stop and restart procedures, evaluating packages for multiple sterilization runs, and making sure suppliers have been audited and approved.

"This method gives you a way to get numerical values for each category," said Miller. "Then you can set priorities for action." Like most quality control tools, the new program is not a magic bullet. But if used alongside a comprehensive training program, it could be a cost-effective way for packagers to make sure the 'r' word doesn't become a reality. For more information, email Hal Miller at hfmiller2@att.net.