Smoothing the Path at CSS
Longstanding employee focus on process control is easing the way to ISO 13485 certification.
By Michael C. Anderson
Connecticut Spring & Stamping (CSS; Farmington, CT), a family owned and managed company with over 380 employees, is set on achieving certification under the ISO 13485 comprehensive management system for the design and manufacture of medical device components. The certification isn’t a requirement—rather, it serves as a commitment that CSS can match the stringent quality management requirements already followed by its medical device customers. CSS, which makes tight tolerance precision springs and metal stampings, prides itself on its process control, and was already certified to ISO 9001 quality management standards as well as the AS9100 aerospace quality management standards. So stepping up to the ISO 13485 medical device quality management standard did not involve massive changes. But the yearlong campaign to achieve the certification does require management support, careful planning and development of training plans and documentation tools, as well as buy-in of the entire workforce.
The Path to Certification
CSS had always done work for the medical device industry, but began focusing on the sector in 2001, in response to the medical industry’s rapid growth. From about 8% of its work, the company aimed to grow its medical sales to about 50% of its total. To do that, CSS began developing its internal process capabilities to meet the requirements of the complex parts being manufactured and the complicated qualification processes required. The company became adept at preparation of medical part protocols to meet the needs of OEMs, who would be taking the parts into a clean room for assembly and sterilization.
Over the past few years, this expanded medical focus naturally progressed into the decision to pursue the ISO 13485 certification, as a way of opening up the company to pursue new business and develop new and more complex parts. “We decided to pursue the ISO 13485 medical quality certification to give customers immediate assurance that we understand the medical business and all the required protocols,” said Steve Dicke, vice president of sales and marketing at CSS. “It makes sense for us—we will not need a team of auditors from prospective customers to review our processes before even being able to quote on a product.”
After making the decision, Gerry Godburn, quality systems manager for CSS, launched a step-by-step process to achieve certification.
The company began by commissioning an ISO13485 gap assessment from CONNSTEP, a Connecticut fee-for-service 501(c) (3) nonprofit organization that assists small and midsize manufacturing companies with critical business assistance. CONNSTEP connected CSS with a consultant skilled at assessing quality management systems. The two-day analysis compared all the procedures required in ISO 13485 with those of CSS, documenting any potential weaknesses, and listing actions that would have to be taken to meet the particular requirement.
“The gap assessment shows where we are currently and what needs to be done, and has become our roadmap for change,” said Godburn. He adds that CSS is now working internally to close the gaps before the pre-audit, scheduled for April 2013, and the full audit, scheduled for May 2013. Because CSS already has the aerospace quality management certification, it had already incorporated quite a bit of the requirements found in the ISO 13485, but the medical standard adds a lot more detail to the risk analysis and validation procedures.
“Everyone, from senior management to our 21 self-directed work teams, is focused on doing what it takes to implement the recommendations found in the gap assessment,” said Godburn. “Our training process will make it clear to everyone in the building that there can be no shortcomings in any of these procedures.”
He reiterates that CSS has always staked its reputation on its firm process control, and already had complete traceability throughout the plant, but ISO 13485’s very precise documentation requirements means that some items require a lot more record-keeping. With ISO 13485, there can be absolutely no change to any part of the process without prior authorization. This covers everything, from raw materials, to production steps, to exactly which machine is used.
For example, ISO13485:2003, sec 4.2.4, Records, stipulates that records are retained for at least the lifetime of the device. CSS’ records procedure must now be updated to specify exactly how that process works. Another example is ISO13485:2003, sec 6.4, Work Environment, stating that control of contaminated or potentially contaminated product must be established and documented. CSS was required to update its quality manual with a statement regarding handling of potentially contaminated product.
How does this translate to real parts on the floor? “Each customer is different,” Godburn said. “For example, one surgical tool customer for whom CSS has worked for more than 40 years used to use a standard one-piece first-article 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 surgical 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 qualification requirements.
CSS also added the specific requirements 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). The 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 program, with small groups tailored for specific work areas.
For example, the company will conduct validation training 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.
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. The goal is to ensure that the problem can never happen again.
The training will use real-life examples to illustrate the process. 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). This was later detected by a CSS customer. An action plan was developed using the structured “deep-dive” process, which included adding a requirement to the supplier’s purchase order to require certification to show actual reduction percent; adding a sequence requiring 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 document 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. Those who know the goals and those performing the activities must be on the same page.”
This article was first published in the 2013 edition of the Medical Manufacturing Yearbook.
Published Date : 12/11/2013