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all-dimension qualification. Now, this same customer may take 30 pieces out of production and require a process capability index (Cpk


) of 1.67 on critical


dimensions, of which there may be many. Another customer, for whom CSS makes a compression spring for a surgi- cal instrument, requires a qualification of three dimensions.” Maintaining such process control


means that CSS will have to ensure it has enough capacity and duplication of workcenters to keep the flexibility it will need to serve all its customers while complying with process qualifi- cation requirements. CSS also added the specific require-


ments of ISO 13485 into its existing CSS Compliance/Correlation Matrix, which lists the more than 160 quality program paragraph citations for the different certifications CSS has or is seeking (AS 9100C, ISO 9001-2008, ISO 13485). Te tool is available internally so those responsible for customer service and sales can quickly locate the citation in a specific policy document that proves compliance with any requirement.


Training Will Be Key CSS workers and managers believe that implementation of


the medical qualification standard will be relatively easy, reported Godburn, because every group within the company has been working for years with controlled processes and the 5S workplace organization method, and is committed to on-time delivery, cleanliness, safety, and quality. To meet the special needs of ISO 13485, the company will undertake an extensive training pro- gram, with small groups tailored for specific work areas.


CSS’s Dale Pelletier programs a Haas CNC machining center. Cause and corrective action training will discuss how to


dig deep enough to find the root cause of any problems found, using a process that completely defines the problem, conducts a step by step investigation, verifies that the solution chosen is “mistake-proof,” and ensures success by tracking solution effectiveness. Te goal is to ensure that the problem can never happen again. Te training will use real-life examples to illustrate the pro-


cess. For example, one recent cause/corrective action focused on the fact that the receiving inspection process failed to detect a missing raw material operation (cold reduction). Tis was later detected by a CSS customer. An action plan was developed us- ing the structured “deep-dive” process, which included adding a requirement to the supplier’s purchase order to require certifica- tion to show actual reduction percent; adding a sequence re-


“Everyone, from senior management to our 21 self-directed work teams, is focused on doing what it takes.”


For example, the company will conduct validation train-


ing using a program adapted from training material prepared originally by a major medical sharps device manufacturer, for whom CSS makes springs and fourslide formed metal parts. CSS used the validation procedure when qualifying springs used in a skin-piercing sharps device used for taking a blood sample. Other training to be conducted includes inspection


training to review sampling requirements, and discrepant material training to explain requirements for dealing with any issues associated with either raw materials received or in-house issues.


88 Medical Manufacturing 2013


quiring verification of cold reduction percentage from material certification for receiving inspection and adding a note to QC the source sequence to verify cold reduction prior to shipment, and directing receiving inspection to forward certifications for review prior to issue to production. According to Gerry Godburn, the goal of the ISO 13485


training is to make sure this high level of process and docu- ment control becomes ingrained in everyone’s daily activities and that everyone buys into the need to document the quality that has always been central to the company’s philosophy: “We all have to live it. Tose who know the goals and those performing the activities must be on the same page.”


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