Originally Published MDDI March 2005

NEWSTRENDS

Ben Van Houten

A new risk management program could help sterile medical packagers cut down on recalls, said industry consultant Hal Miller. Miller, president of PACE Solutions LLC (Cape May, NJ), presented Medical Design & Manufacturing (MD&M) West conference attendees with the new survey-style program. “It is every packager's goal to have zero recalls,” said Miller. “This gives you a tool to accomplish that.”

Miller served as Johnson & Johnson's director of packaging technology before becoming a consultant. He stressed that it is important for companies to perform a risk assessment to determine whether their products meet minimum essential requirements. By tracking and analyzing recall root causes to find the areas most susceptible to risk, packagers can improve recall rates, he said.

Miller explained that the root causes of sterile package recalls fall into four main categories: material, including qualification and supplier quality; people, including systems and training; packaging, including design and testing; and process, including equipment, validation, and controls. 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 to zero recalls,” he said.

He stressed that this risk assessment should involve a team approach with participation from package development, procurement and supplier quality, engineering and equipment maintenance, and manufacturing operations.

The risk assessment program, developed by an interdisciplinary team of industry experts, uses a series of packaging risk surveys to gather accurate data on various categories. 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. The questionnaire lists simple questions for each category, with check boxes to indicate degree of compliance with quality control steps. “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.”

Undertaking 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.” He added that any score greater than zero will need attention or corrective action, and he stressed that the method will force compliance and dramatically reduce recalls.

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