“Past performance is not sufficient. Increasingly, customers want to know how we check for quality,” explains Dr. Satish Dixit, Director of Engineering/Research and Development at Plasma Technology Inc. “One trend from a quality standpoint is that the way we test and measure has to remain on the cutting edge,” adds Jan Wesley Refsdal, Director of Quality Assurance at Optiforms Inc., a contract manufacturer of electroformed products and optical coatings. Many experts stress the importance of demonstrating and monitoring quality along with challenges and opportunities associated with third party auditing.
“As more testing and monitoring equipment becomes accessible to the manufacturer, it seems likely that sophisticated, physical testing, surface analysis, and chemical monitoring will be expected,” notes Doug Sear, Facilities Manager at Optiforms. “In the past, the customer did not have a spectrophotometer; we did. Increasingly, our customers are investing in their own test equipment to verify performance.”
Dixit says, “Customers may have set up a benchmark for performance 5 or 10 years ago. Originally, performance could oscillate around the benchmark. Now, customers are saying ‘no fluctuations, no sliding below the benchmark.’ They want the job shop to stay over and above the benchmark. The acceptable level has become the minimal level for acceptance.”
Third party auditing
Refsdal continues, “A second trend from a quality standpoint involves the growth of subscriber-based auditing resulting from a change in the customer base.” In the past, the biggest customer was the government and there were many prime contractors; each contractor would have criteria for auditing the quality of contract manufacturing. Refsdal sees an ever-increasing influence of third party, subscriber-based auditing, notably Nadcap, for aerospace and automotive. He adds, “The Nadcap approach allows suppliers to put more time and effort into providing quality product instead of continuously preparing for audits.”
“In the thermal spray world, you have to be Nadcap-approved or you won’t play in the engine or aircraft market; and 85 percent of our revenue is aircraft — new and overhauled,” asserts Robert Dowell, President and CEO of PTI.
Dixit says that “with ISO and Nadcap, there will be an expectation of the combination of consistency, reliability, and performance. I don’t see decreased Nadcap oversight; I see more stringent conditions to be met to produce a better quality product.”
Third party auditing in medical devices
The Nadcap approach is being applied to medical devices. Julia Markardt is Staff Engineer-Electronics, MedAccred/Nadcap, at the Performance Review Institute. PRI administers process accreditation programs, including Nadcap and MedAccred. Markardt says that “the goal for contract manufacturers and final assemblers participating in the program is to conduct rigorous audits of the process. This includes comprehensive reviews of documentation including the signoff of paperwork such as the bill of material, certificates of conformancy, and a device history record, throughout the entire manufacturing process.”
As with all critical processes, in electronics assembly, the OEMs develop stringent audit criteria. “Process control is mandatory. Employees have to be certified as being acceptably trained in performing the process. The audit is extremely detailed; for example, we check the solder pots to be sure they are not contaminated. We look at the limits of the cleaning solutions. The cleaning process itself has to be described; and we look at the work instructions as well as process validation. Part of process validation includes assurance that every component placed on the board is compatible. Compatibility encompasses both compatibility with other process requirements and biocompatibility,” says Markardt.
Connie Conboy, Director, Strategy and Business Development at PRI, explains that MedAccred audits are relatively new and are distinct from quality systems audits. ISO 13485, a quality standard based on ISO 9000, is one example of an acceptable quality system certification. Conboy predicts, “In terms of the future, I see the medical device industry’s overall approach to supply chain controls operating differently. With the integration of the program to enhance the OEM’s existing supply chain control programs it is likely that there will be fewer audits for the suppliers. The audits will be standardized, and the auditor will be a highly experienced expert in the critical process.” Because medical device manufacturing has product-specific requirements, Markardt notes that parts of the audit may be customized to the requirements of a specific OEM, this is achieved by the creation of OEM-specific audit criteria which are included in the audit scope depending on who the contract manufacturer or supplier is working for.
Quality and productivity
Shawn Huber, Director of Operations at Medline Industries, sees “a whole world of analytics to consider in hospital and acute care.” He says better control is already increasing because “with the Affordable Care Act, hospitals may not get full reimbursements for what ought to be avoidable incidents of infection.”
Robert McGinty, Vacuum Coating Supervisor at Optiforms, predicts that Nadcap and ISO requirements will become increasingly more constrictive and will slow production. “One common practice is to reuse chemicals in instances where, based on experience, results have been acceptable. With ISO and Nadcap, we would have to monitor all chemicals for quality or constantly purchase new chemicals.” He predicts an increase in paperwork and ultimately an increase in cost, and says there could be “a two-tiered system with two production streams to segregate Nadcap from industrial projects.”
It seems likely that successful contract manufacturers will leverage their expertise by taking a more active role in setting requirements and in working directly with the customer. A good contract manufacturer can be an effective partner by being informed about changes in standards and in the regulatory landscape and by working with the customer. Huber explains that “every year something new happens in the regulatory environment. The FDA may audit differently; the customer may not even be aware of the changes.”
Barbara Kanegsberg and Ed Kanegsberg (the Cleaning Lady and the Rocket Scientist) are experienced consultants and educators in critical and precision cleaning, surface preparation, and contamination control. Their diverse projects include medical device manufacturing, microelectronics, optics, and aerospace. They can be reached at firstname.lastname@example.org.
This article appeared in the March/April 2016 issue of Controlled Environments.