This is the first in Kenmode's blog article series entitled "10 Metal Stamping Quality Indicators for Medical Device Manufacturers" to help medical device manufacturers evaluate the level of quality in their metal stamping suppliers. The series will consist of 10 articles, published weekly. Each article will focus on a single quality indicator.
Metal stampings may appear to be small components of a much larger product, but their quality can make a huge difference in the reliability and useful life of the product. OEMs can benefit by evaluating whether a metal stamping supplier strongly demonstrates a commitment to quality through:
Top management involvement
Quality should not be relegated to the “Quality Department,” if it is truly an organization-wide value. Instead, top management will embrace quality as a core value and will be involved in reviewing quality metrics and processes, investing in improvements, and instilling a quality culture throughout the organization. According to the 2011 FDA report, Understanding Barriers to Medical Device Quality, “Interviewees whose companies experienced quality issues typically did not track quality metrics at the executive level, and quality was considered the domain of a specific organization rather than a CEO level agenda item.”
A commitment to zero defects
The management of a metal stamping company should be firmly committed to delivering zero defects and should demonstrate that commitment by processes and policies that take responsibility for delivering quality stampings. A strong prevention focus will help to avoid quality issues from the start. An advanced detection system will identify problems as soon as they occur. Of course, no manufacturing process is perfect, no matter how extensive the quality controls. An evaluation of stamping suppliers must include how the company handles defects. The entire team should be aware that even one defect is one too many. A strong corrective action process is necessary. Every employee should be aware of quality standards and understand their role in achieving zero defects.
Dedication to continual improvement
In medical device component manufacturing, quality does not equate simply to adherence to regulatory compliance. As important as that may be, compliance is only the beginning. True quality depends upon a commitment to excellence in all areas of the manufacturing process – from design to post-production. To maintain the highest quality standards, a metal stamping supplier should be dedicated to continual improvement in quality processes, to employing a lean manufacturing philosophy, and to investing in advanced quality control systems and technology to detect problems in real time.