Union City Receives Its California FDB Device Manufacturing License
SigmaTron International’s facility in Union City, CA has received its Device Manufacturing License from the State of California’s Department of Public Health Food and Drug Branch (FDB).
Applying for the FDB California Device Manufacturing License is the first step in our process toward registering SigmaTron International’s Union City operation with the FDA for medical device manufacturing as a contract manufacturing facility.
SigmaTron Upgrading to New Quality Standards
Virtually all of the key quality standards Sig-maTron International is certified to are rolling to new revisions this year. There have been enough changes in format that this has driven a more comprehensive approach in documen-tation assessments than with the last set of major revisions. ISO 9001:2008 is transition-ing to ISO 9001:2015, ISO 13485:2003 is transitioning to ISO 13485:2016 and the au-tomotive standard ISO/TS 16949:2009 is transitioning to IATF 16949:2016. The aero-space-related standard AS 9100 changed from C to D, as well.
“We began the transition process last year. Each facility has managed its own transition, utilizing consultants who are expert in the revi-sions to assist with gap analysis. Risk analysis has been the biggest element of change in the new standards. Our existing quality systems address this, but not on the scale envisioned in the new standards,” said Allen Abell, Corporate Director of Quality and Compliance.
SigmaTron International’s facilities in Vietnam; Acuna, Mexico; and Tijuana, Mexico have now all passed their ISO 9001:2015 audits. The Union City, CA facility has just had the ISO 9001:2015 and AS9100 Rev D audits and has been recommended as approved for the upgrades. The facilities in Elk Grove Village (EGV), IL and Chihuahua, Mexico will be audited for ISO 9001:2015 in April and May, respectively. The Suzhou, PRC facility will be audited in June.
EGV will also be audited to ISO 13485:2016 in April.
The Suzhou, PRC facility undergoes its ISO 13485:2016 and IATF 16949:2016 audits in June, as well. While the Suzhou facility was certified to ISO 13485 previously, this will be the first certification to the automotive quality standard.
The Union City facility and the Tijuana facility will be audited for ISO 13485:2016 in the summer.
The Tijuana facility audit for IATF 16949:2016 will be in July.
According to Abell, in most cases addressing the enhanced risk management element in ISO 9001 required plant teams to perform a Failure Mode and Effects Analysis (FMEA) on key processes and make minor adjustments to procedures or quality manuals as a result of the gap analysis on requirement differences.
The governing body on 16949 has changed from the International Standards Organization (ISO) to the International Automotive Task Force (IATF) and that has resulted in a broader requirement shift for that standard. The revisions in ISO 13485 also drove some changes to procedures.
“Since SigmaTron has grown by acquisition in several cases, we’ve traditionally managed the quality system certifications at a plant level since there can be slight variances in procedures. One of my goals when appointed as Corporate Director of Quality and Compliance was to start a move towards a standardization effort over time. We’ve chosen to complete the transition to these new standards at the facility level. However, once we have two facilities registered to either ISO 13485:2016 or IATF 16949:2016, we will need to adopt a harmonized corporate standard. So, we are working toward that requirement, as well,” added Abell.
Anita Tucker Promoted to Elk Grove Village General Manager
Anita Tucker has been promoted to SigmaTron International’s Elk Grove Village, IL facility as General Manager. Previously, she was the facility’s Director of Program Management.
She was earlier the Director of Manufacturing Engineering and Facilities for Generation Brands. Prior to that she was associated with Shure Incorporated in a variety of manufacturing management and plant management roles. She reports to Jim Barnes, EVP of EGV and ACU Operations.
“We initially hired Anita for her expertise in leading our program management team. However, we’ve found her breadth of expertise in manufacturing engineering, Lean manufacturing and production planning makes the right choice for a much broader role. Her more than 20 years of experience in manufacturing management is a significant asset in our efforts to continue to raise the bar in terms of responsiveness and flexibility in our manufacturing operations,” said Jim.
In her new role, Anita plans to focus strongly on improving the new product introduction (NPI) process and continue the focus on applying Lean manufacturing principles to EGV’s high mix production operations.
“I believe we can enhance the NPI pro-cess with a more structured approach to project planning that incorporates some of tools developed by the Project Management Institute (PMI). I also want to work toward enhancing EGV’s flexibility with small runs through application of the best Lean, MRP/planning and program management tools to achieve our improvement goals,” said Anita.
She received a Bachelor of Science degree in manufacturing engineering from Bradley University and a Master of Engineering Management degree from Northwestern University. She holds a Project Management Professional (PMP) certification through PMI and a Green Belt certification through the Project Management Academy (PMA).
Green Compliance Center Ready to Address Updates in Requirements
The Green Initiative Compliance Service Center is one example of ways that SigmaTron International goes the extra mile to ensure materials integrity and regulatory compliance. The center is located in Taipei, Taiwan and interfaces closely with component engineers and procurement professionals to gather necessary materials documentation from suppliers related to regulatory, social and environmental initiatives such as RoHS, RoHS II, REACH, Conflict Minerals and California’s Proposition 65, as well as customer specific initiatives. The Compliance Center communicates with the rest of the Company’s supply chain management organization.
Specialized software supports the operation by providing updates as monitored jurisdictions create new rules or modify existing rules. The tool can also be programmed to support customers who have specific lists of substances and materials that they want to track.
REACH has been increasing every six months and is now up to 181 chemicals that must be tracked. RoHS III will kick in July 2019 and adds four more substances. The Compliance Center started trial work on those anticipated changes. They have also added to the International Material Data System (IMDS) to support SigmaTron’s automotive customer base.
Line Balancing Functional Test
Hom-Ming Chang, SigmaTron International’s Vice President-China Operations discussed key considerations in line balancing functional test in the January issue of Circuits Assembly.
The article discussed potential solutions to some of challenges faced in paced assembly lines with integrated testers including:
- Length of test time vs. standard time per assembly station
- Accommodation of system variation
- Determining the best mix of automation and human interaction
- Fixture reliability in a high-volume environment
- Fail-safing the process from operator error.