Fluke Biomedical was handed a five-observation Form 483 because it failed to properly select any of the suppliers for its CLEAR-Pb X-Ray shielding products.
The Cincinnati-based company’s supplier assessment request form — used to qualify suppliers — does not require quality system information to evaluate their ability, according to the Feb. 9 Form 483. Four out of the five suppliers had no certification, such as ISO, and no documented evidence of an adequate quality system. Additionally, Fluke did not determine whether they validate and monitor processes for manufacturing Fluke’s components.
According to the purchasing procedure, if a supplier has a quality rating of less than 80 percent for three months in a row, Fluke must review the nonconformities, conduct evaluations, share the results with the supplier and open a supplier corrective action. The company gave an unacceptable rating to one of its suppliers since at least March 2015, but there was no evidence of supplier communications or a supplier corrective action request.
According to Fluke’s supplier handbook, supplier status should be noted on an approved supplier list. However, this was not the case for any of the CLEAR-Pb suppliers.
Meanwhile, the company does not have a dedicated area to segregate nonconforming products. “During this inspection, nonconforming product was found in the same area as released and un-inspected product,” the form says.
It also notes that according to the company’s deviation procedure, “a deviation is a temporary or short-term approval of a change that is applied to a limited number of units or components.” The inspection found Fluke had been creating temporary deviations for nonconforming product from one supplier since at least June 2011.
A review of eight returned material authorizations over the past three years showed three instances that appeared to meet the definition of a complaint for the CLEAR-Pb radiation shield products. However, the company had not opened any complaint files.
A review of nine device history records over the past year of shipments for the mobile radiation shield also showed Fluke is not following its procedures for device history records. For example: