Perrigo Applies Crime Scene Investigation Model to Improve Quality Control

Perrigo quality control managers emphasize immediate investigations of low-risk incidents and forward-looking remediation in the firm’s new corrective and preventive actions strategy.

At the Consumer Healthcare Products Association’s Product Quality & Operations Workshop Oct. 6, Quality Engineering Manager Mike Reske said Perrigo realized its deviation response processes were lacking in their approach toward low-risk events on the production line, such as the appearance of isolated, well-characterized foreign matter or a wrinkled label.

“When you have these lower-risk incidents and they’re nuisance things that keep happening … really what they are is an indication as to what’s coming down the road,” said Reske at the workshop in Bethesda, Md.

The private labeler is making CAPA adjustments at its Allegan, Mich., facilities, which drew an April 2010 warning letter from FDA following inspector findings of inadequate standard operating procedures and QC investigation failures (Also see "Perrigo Takes Two Steps Forward: Generic Allegra Launch, Manufacturing Compliance" - Pink Sheet, 18 Apr, 2011.) (Also see "FDA Focuses Latest Warnings on Accountability and Root Cause" - Pink Sheet, 1 Jun, 2010.).

Perrigo returned to regulatory compliance and received FDA clearance to resume full production in April after operating at reduced capacity in Allegan during a remediation process the firm said cost between $10 million and $15 million.

CSI: Allegan

With the new emphasis on low-risk event responses, Reske said Perrigo now treats every SOP deviation as if it were a crime scene, requiring an immediate response by QC personnel and technical subject matter experts to measure the scope of the issue, contain the affected product and document the event.

The crime scene analogy, suggesting a “dead body” on the plant floor, helps staff overcome the urge to quickly restart production before a root cause investigation is complete, Reske said.

“When you get on the floor level, they’re thinking … ‘How do we get this thing going? Get this dead body out of the way, let’s go!’” he said.

However, a rushed investigation “can travel down a very wrong road simply because you’re lacking some piece of evidence,” Reske added.

To illustrate the effectiveness of an immediate and thorough investigation, Reske recounted an incident in which a piece of rubber was found in a mixing vessel. The investigation determined maintenance workers recently had been on the floor and the rubber piece was traced to the handle of a screwdriver.

“It really highlights the idea that the sooner you get out there, the sooner you get people who are on the floor out to the scene of the crime, the better off you are,” Reske said.

Increasing Preventive Action Effectiveness

Investigations are followed by CAPAs addressing the root causes of SOP deviations. But beyond simply patching up in the wake of an incident, Perrigo focuses on preventing repeats, Reske said.

By weighing the probability of recurrence over retrospective analysis, effective CAPA practices can stop a low-risk problem from metastasizing.

A good CAPA will “prove to me up-front that this can’t happen again,” Reske said.

“I’m going to do my checks [and] I’ll still go back several months and say, did it happen again? But I’ve got a much better feeling inside as a quality guy to say this isn’t going to happen again.”

As an example, he said after an employee found a stray tablet on top of an electrical outlet along a packaging line, Perrigo QC staff decided to institute a CAPA repositioning the outlets so the tops are not level.

But rather than assume the line clearance problem was solved, an engineer suggested pouring tablets on the angled outlets to see whether any would stick.

“When I put this preventive action in place, [the deviation] should never happen again,” Reske said. “And yet, we don’t know that until it happens again. Then we know it didn’t work.”

Marshaling Additional Quality Resources

During a question-and-answer session, Perrigo VP of Consumer Healthcare Quality Operations Paul Weninger said investments to improve root cause investigations and CAPA practices ultimately pay for themselves.

When asking management for more resources, compare the total cost of quality to the cost of potential failure, he said.

The hidden cost of failure “far exceeds what’s the cost of a lost batch, what’s the cost of the scrap and the rework,” Weninger said. “Start looking at that and suddenly the additional resources online are small if you can make a significant dent.”

Another Perrigo presenter, Associate Director of Quality Erika Ballman, said the firm’s revised take on root cause investigations and CAPA is about four months old and already is reducing SOP deviations, though it will take more time to realize and measure its full impact.

[Editor's note: This story appears courtesy of the editorial staff of ‘The Tan Sheet,’ your source for coverage of nonprescription pharmaceuticals and nutritionals. For a sample copy, call customer service at 800-332-2181.]

By Dan Schiff