AS9100 Transition Drives Technical Excellence
Arthur Ackerman, Mini-Circuits
Technical excellence at Mini-Circuits is coming into sharper focus as we approach the fifth decade since our founding by Harvey Kaylie in 1969. This focus has been emphasized in our current initiative to recertify our quality management system (QMS) to the new revision of AS9100. As you may expect, Mini-Circuits places the highest priority on product quality, and this has had many benefits for us and our customers. Our customer returns have been consistently below 10 PPM over the past year, and we will continue finding ways to drive this metric even closer to zero.
Mini-Circuits is a world-renowned innovator and supplier to the RF and microwave industries with more than 15,000 active component-level devices and test systems. Our stated commitment to our customers is to provide product continuity and avoid obsoleting any products that have been designed into customer systems. In addition to maintaining availability of active legacy models, we regularly add more than 1000 new products to our line annually. This places a heavy burden on us to ensure the robustness of design and materials as well as the overall quality of our systems. Consequently, while the new revision of AS9100 includes a number of significant changes, many of its elements have historically been incorporated into Mini-Circuits’ QMS.
We received our first ISO9001 certification in 1997, and this was expanded to AS9100 in 2008 based on the requirements of our aerospace customers. AS9100 Revision D has finally been released after months of delays, marking the first major change to the standard in many years. While some suppliers look at these changes with trepidation, Mini-Circuits welcomes them and considers the new requirements a validation of our existing policies.
The revised standard takes previously ‘generic’ elements and expands upon them to build a more rigorous approach to quality and technical excellence as demanded by the aerospace industry. Our challenge is to incorporate these elements into our already-rigorous QMS. Mini-Circuits has two full-time internal auditors and a team of twenty volunteer auditors from various departments. We typically conduct more than 150 internal audits per year. Our transition to Revision D has included external training of key members and a formal internal retraining of all supervisory staff to the rewrite of our QMS.
The major changes to the standard include:
- Replacement of ‘preventive action’ with ‘risk assessment’
- Increased focus on metrics and goal achievement
- Implementation of control processes, like APQP, in design and development
- Anti-Counterfeit and Product Safety measures
- Emphasis on Leadership and identifying ‘affected parties’ and their interactions
The change from preventive action to risk assessment is part of a more forward-thinking approach. The objective is to step away from the traditional, retroactive mentality of ‘fixing’ problems to actually anticipating them before they occur and building in the necessary controls or tests to detect and mitigate them. One of the most common techniques for Risk Assessment used in the industry is Failure Mode Effect Analysis (FMEA) which can be done for design, process or materials.
Mini-Circuits has used FMEA for several years, building on our wealth of collected data to predict failure and marginal designs or processes. This is used to identify the risk of outliers passing through our system and propels a solution to block these outliers. Having this requirement built into the standard validates our historic methods and will improve the quality of the industry as a whole.
Metrics and Goal Achievement:
Use of metrics and data is the very foundation of any technical enterprise. Without them, everything would just be guesswork. Mini-Circuits is a data-driven company, and we make use of this data to continuously improve our products. One of the main uses of the data we collect is to ensure that our devices perform consistently in lot-to-lot and within-the-lot comparisons, without relying solely on ‘meeting spec.’ This is done with proprietary software to compare current lot performance with historical data, flagging any shift of sigma value greater than 0.25.
In addition, every major activity within the company is assigned a goal, such as throughput, first pass yield, etc. The difference in the new standard, however, is that actions are now required if the goal is not being met. Failure to take such actions, or the absence of visible improvement from actions taken, is now considered as a ‘finding’ or non-conformance to the standard.
Again, this tightening of the system will result in positive improvement and higher levels of technical excellence.
Design and Development:
The revised AS9100 standard includes a ‘suggestion’ that operational planning and control use Advanced Product Quality Planning (APQP) as a method for creating a structure for timed events and sequences of approval in the product development process. This will enable review of risks, robustness, cost and delivery scheduling.
APQP is not a new concept, and Mini-Circuits has been using an internal form of this technique for decades. Nevertheless, having it included in the revised standard will elevate all suppliers’ quality.
The immense growth of counterfeit materials in the RF and microwave industry within the past five years is the result of uncontrolled and unscrupulous suppliers using ‘back-door’ channels to infiltrate the market. This is enabled by use of unauthorized distribution, and the use of sub-standard or counterfeit parts can have a devastating impact in an industry where lives are at stake.
Mini-Circuits has long recognized this as a major problem and has even seen products being falsely represented as ours. Our policy has always been to aggressively pursue false claims and misrepresentations in the marketplace.
We also require that all suppliers to Mini-Circuits be OEMs, Franchised Distributors or provide letters of authentication from the manufacturers. We maintain laboratory facilities and analytic capabilities to verify raw materials as needed.
Leadership and Affected Parties:
Perhaps the most significant change to the standard is also the most subtle one. This is the change from ‘management’ to ‘leadership,’ and a new look at how we interact with ‘affected parties’. This is a dramatic departure from the ‘top-down’ approach typically used in management review meetings, evolving to a wider distribution of leadership throughout the organization.
All Mini-Circuits members have a stake in the ongoing success and growth of our company. This growth can only be achieved when we all work together to satisfy the customer. This includes our drive to achieve the technical excellence, outstanding quality and service that exceed customer expectations.