Since Connecticut Spring & Stamping (CSS) made a strategic decision to grow its medical business, the company has taken a number of actions to stay a step ahead in the rapidly growing medical field. Among the most important was the decision to obtain certification under the ISO 13485 standard for quality management for design and manufacturing of medical devices.
While not, as yet, required by customers of prospective clients, the company believes the standard will be specified in future, and this was the underlying impetus for its decision to obtain the certification. Furthermore, the company predicts greater use of cleanroom technology for the assembly of medical products in the future and believes ISO 13485 certification positions its business well for this eventuality.
For more than 25 years, CSS has supplied medical device OEMs with tight tolerance springs used in minimally invasive handheld surgical devices, as well as metal stampings for handheld surgical devices, endoscopic clip appliers, suturing devices, and staple removers. In 2001, the company took the decision to focus more on the medical market, which was about 8% of its overall total at that time. Since then, the medical business has grown to 25–30% of total company revenue, which has also seen high year-on-year growth. Ultimately, CSS would like 50% of its business to be in the medical market within the next few years.
The strategic decision to make the leap to ISO 13485 certification was viewed as a natural business progression and, perhaps most important, was not seen as too much of a leap from its existing, very rigorous focus on quality. The company has carried out work for the aerospace industry since the 1950s and is currently certified to AS9100, the standardised quality management system for the aerospace industry, so it felt confident that it could meet any new medical quality requirements.
OEMs did not pull existing mature product from vendors without the AS9100 certification, but anyone seeking to open up discussions on new business had to be certified
In a similar set-up to the medical industry, AS9100 was not required originally, but about 10–12 years ago, OEMs such as Boeing, General Electric and Pratt & Whitney mandated that any suppliers who wanted to win new business would have to achieve the certification. OEMs did not pull existing mature product from vendors without the AS9100 certification, but anyone seeking to open up discussions on new business had to be certified. That was the first time the company saw the ‘writing on the wall’ and it believes it is extremely likely that the medical device sector will follow the same evolution.
About a year ago CSS began the ISO 13485 certification process. The initial push came from top management, who allocated the resources and personnel to achieve the goal. It was then rolled out companywide to all the job functions involved. The project was spearheaded by Quality Systems Manager, Gerry Godburn, who contracted with CONNSTEP, a non-profit business consulting organisation that specialises in assisting manufacturing firms implementing ISO quality management systems.
CONNSTEP performed a thorough documentation review, followed by an on-site visit to review and assess the company’s day-to-day operations. It then prepared a gap analysis, recommending changes to be implemented to prepare for the 2013 certification audits, which are being conducted by American Systems Registrar (ASR), an ANAB accredited and IATF approved registrar.
Phase 1 of the audit, a review of systems, procedures and documents, will take place by the autumn of 2013, followed by Phase II a few weeks later, when auditors will check to ensure CSS is actually doing everything it should. Final notification should come within 60 days of the Phase II audit. CONNSTEP’s gap analysis revealed that CSS was closer to compliance with ISO 13485 than originally thought. The company rewrote its entire quality manual to follow guidelines, but in effect the gap analysis required the development of only a few new procedures and IQ/OQ/PQ (Installation Qualification/Operational Qualification/ Performance Qualification) equipment validation processes, which have been submitted to about half a dozen customers.
CSS also added features to its existing software system to lock down process control for medical customers. This is similar to the locked down processes that CSS has been using for years with automobile and aerospace customers, so was not a significant leap. A locked down process means absolutely nothing can be changed in a process for a medical part, no matter how minor, without a notification for shop documentation that goes out to the floor and is formally approved by the customer.
Another requirement of the ISO 13485 quality management system is addressing the issue of risk management during product development. AS9100C has a specific definition of risk: an undesirable situation or circumstance that has both a likelihood of occurring and a potential negative consequence. By contrast, ISO 13485 does not define what constitutes a risk but does require that the organisation establishes documented requirements for risk management throughout product realisation, and that records arising from risk management are maintained.
To meet this requirement, CSS developed a process in which potential risks are identified and evaluated at the beginning of an order for a new part number or revision change to an existing part. The areas evaluated include:
- Methods (manufacturing processes)
- Manpower (do we have the right people, in correct numbers, with proper training?)
- Measurement (do we have appropriate ways of evaluating the product?)
- Material (are the sources for materials readily available, appropriate, and consistent?)
- Machines (do we have the appropriate machinery to perform the work and in the right numbers?)
- Mother Nature (do we need to have a disaster plan?)
- Other factors, as appropriate.
The biggest issue involved in conducting the required risk evaluation is obtaining appropriate information from customers to make the analysis meaningful
CSS uses the risk evaluation to provide an estimate of the risk exposure to the company and its customers. Based on the estimated risk, it tailors an appropriate course of action to reduce or eliminate the risks associated with a particular part and keeps records on actions it takes. For example, although not a significant risk issue, the company is currently looking into developing the capability of laser-marking some medical product to eliminate the use of epoxy inks.
The biggest issue involved in conducting the required risk evaluation is obtaining appropriate information from customers to make the analysis meaningful. This is an area that CSS is working to improve by earlier co-ordination with customers.
Very little was called necessary with regard to such issues as environmental monitoring and contamination control. While CSS currently has no cleanroom environment, the areas where medical device components are handled are blocked off so that airborne dust contamination is at a very low level. This is particularly true in the assembly and inspection areas, which are contained in an enclosed room. In addition, CSS’ ongoing 5S continuous improvement programmes focus on a clean environment.
The biggest challenge CSS has in implementing tighter process control is changing the existing mindset to encourage more open dialogue; the company has to ensure that, if operators are not sure that the process is operating properly, they stop and question the process. As a result of the ISO 13485 quality management methods now in place, the company has seen a greater prevalence of open dialogue between different departments.
Many of the medical components handled require a number of machining operations
For example, employees are beginning to question if a part is clean enough, especially when it has been sent out for outside processes. For one medical component used in a surgical stapler, the company eventually determined that it had to change the supply source for outside processes because existing services were not as consistent as needed to meet the guidelines. The part required three separate operations (passivation, marking, Teflon coating) with three different vendors, and each time the part came back and went through quality inspection, there might be an issue.
Eventually, the company developed a source that would do all three processes in one batch, so when the part comes back, CSS needs to perform only one quality inspection. This change is expected to save both cost and time, and really improves the overall product.
The company fully anticipates the need for a cleanroom environment in the future for medical device customers and certification to ISO 13495 is the first step towards that future. Although not a direct result of the ISO 13485 certification process, CSS is considering development of an additional facility due to the growth it is experiencing and the need to add expanded capabilities to meet medical device customers’ needs. Currently it is processing a few parts that are going through the final step of passivation. Those that require a cleanroom are typically passivated and packed at an outside service with a cleanroom, and then returned to CSS. The new facility is being designed with two cleanrooms for medical device assembly. Again tracking what has happened in the aerospace industry, not too many years ago Pratt & Whitney initiated a foreign object and dust particulate contamination protocol, and CSS envisions that such requirements will soon follow in the medical field.
A final future requirement resulting from the forces driving towards ISO 13485 certification is the need for a more robust lab for in-house quality measurement and testing, as well as equipment calibration. This is also under consideration during design of the new facility.
Achieving ISO 13485 certification is one way to stay one step ahead of where CSS needs to be to attract and keep its medical customers. In addition, certification demonstrates to prospects an understanding of the medical markets, familiarity with medical protocol, and should also minimise the need for facility audits by customers and prospects.
