MedAccred is a Nadcap-style accreditation program established by medical industry original equipment manufacturers (OEM) in the medical device field and operated as an industry-managed system by the Performance Review Institute (PRI). During 2014 the MedAccred program has gathered steam slowly, but steadily.
Regarding the heat treat task group specifically, there are three OEM subscribers and four suppliers actively participating in regularly scheduled meetings. There are four checklists available for auditing and two more in the works as this is being written. Currently there is one audit scheduled on the books for January 2015. None of the current subscribers has yet to place any mandates for accreditation on their respective heat treat suppliers. Several other OEM’S regularly participate in the meetings signaling their possible future interest in becoming subscribers.
In the course of discussion with the OEM’s at the heat treat task group meetings it was apparent that adoption of auditable standards that would be significant to their interests had to include Pyrometry. AMS2750 was the only logical choice for a widely used industry-consensus standard so it was decided to adopt it as the default practice in order to assist in checklist development. In a wider sense, the general lack of industry-consensus standards adopted by the medical industry has proven to be a challenge and it engenders discussion every time the participants get together.
The available checklists include a base checklist similar to the Nadcap base checklist which includes questions on Pyrometry and several job audits to be completed, plus a checklist each for room temperature tensile testing, hardness testing, and microhardness/metallographic testing.
Considerable discussion has been had about “process validation” in the medical device industry. The OEM’s agree that process validation, as practiced by each OEM, is a long-standing tool within their quality tool boxes. However, there is no industry-consensus standard to which suppliers can turn for uniform practice and application. MedAccred and the OEMs are working with suppliers to educate them about process validation and its importance in the medical device industry. The current heat treat checklist does not address this requirement very well. It is likely that the next revision will have checklist questions added to it, worded in such a way as to address the matter and satisfy the needs of the OEM’s.
Although the current subscriber level for the entire program (commodities include welding, sterilization, cable and wire harness, printed circuit boards) is not particularly high at the moment the level of OEM participation in the management council meetings and individual commodities has been significant. The program is on the radar screen of the FDA as well. With the exception of sterilization, each of these commodities was selected because they were built upon existing Nadcap checklists which also had medical device application, enabling them to be the most expeditious to apply to the medical device industry. This is an industry effort well worth watching due to the possible effects it will have on the heat treating businesses represented by MTI.