Over the past few years the printed circuit board industry has had numerous regulatory and compliance initiatives forced upon it. Some of these may have been well intentioned but the unintended results have yet to be realized. For example, many of us are familiar with RoHS, Restriction of Hazardous Substances directive. The directive restricts the use of several substances by manufacturers. The only substance restriction that really affected the printed circuit board industry was Lead. Tin-Lead solder was used in the industry for decades. RoHS sought to remove Lead from the electronics industry. Many people recall how harmful Lead in gasoline and paint proved to be to both the environment and the human condition. Removing Lead from electronics would sound like a good idea. Right? (more…)
Archive for the ‘Certification’ Category
In part one of this series we discussed the purpose of ITAR (International Traffic in Arms Regulations) and the government agency responsible for it’s oversight and enforcement. We also talked about what items are covered by ITAR through category 21 of the USML (United States Munitions List) and what the potential penalties are for violations. In this posting we shall talk about who ITAR applies to and the registration process.
Why do we have to register for ITAR?
Registration provides the United States Department of State necessary information used monitor and regulate defense items that are manufactured, imported and exported. It is important to point out at this point that (more…)
ITAR is an acronym for the International Traffic in Arms Regulations. The purpose of ITAR is to safeguard and control the export and import of defense related information and technology related to and that appear on the United States Munitions List (USML). ITAR is a set of regulations that came into being in order to implement provisions of the Arms Export Control Act of 1976 (AECA). The United States Department of State Directorate of Defense Trade Controls (DDTC) interprets and enforces ITAR. The mission statement of the DDTC is as follows…
The U.S. Government views the sale, export, and re-transfer of defense articles and defense services as an integral part of safeguarding U.S. national security and furthering U.S. foreign policy objectives. The Directorate of Defense Trade Controls (DDTC), in accordance with 22 U.S.C. 2778-2780 of the Arms Export Control Act (AECA) and the International Traffic in Arms Regulations (ITAR) (22 CFR Parts 120-130), is charged with controlling the export and temporary import of defense articles and defense services covered by the United States Munitions List (USML).
The USML in its entirety may be found here. The list is segregated into 21 categories. Most categories cover specific technologies, equipment or applications. The important classification that you need to be aware of is (more…)
For a manufacturer calibrations are a critical aspect of the ISO system. A calibrated device helps ensure consistency with the product. What needs to be calibrated? A device or tool that is used to qualify the process or product. What standard should be used? Calibrations must meet NIST standards. NIST is short for National Institute of Standards and Technology which is an agency of the US department of commerce. Why do we need to meet NIST standards? The standards are a base line for measuring standards. A device calibrated to the NIST standards is considered consistent with other devices calibrated to the same standard. A micrometer at company A provides the same measured result as the micrometer at company B. Who can certify to NIST standards? NIST provides calibration services. There are also a multitude of laboratories and calibration services certified to NIST standards.
Does everything need to be calibrated? No. Its doesn’t hurt to have everything calibrated. But this would be an extra added expense that adds cost where its not really necessary. For example, (more…)
Is your vendor ISO certified? Have you verified the status of their certification with their registrar? In a world economy in recession/depression these are questions that everyone in a position of responsibility should ask. Tough economic times are forcing some companies to drop their ISO certification and cut corners that should not be cut.
ISO 9001:2008 is all about securing a stable supply chain. All of the components of the standard contribute to this. ISO provides tools and methodologies that can be used to select, qualify, monitor and dis-qualify vendors in the supply chain. How a vendor is selected is up to the buyer and team members. However, once selected the vendor must be qualified in a way that ensures that they have their act together. Can they provide a consistent product on-time and at a fair price. This is where ISO comes in.
Nothing beats an on-site audit. Get in their face and ask questions. Ask to see (more…)
The Management Review component of ISO 9001:2008 is very important. Unfortunately most organizations do not take advantage of the benefits the Management Review component offers. The Management Review component tracks the major components of the ISO system in place. Most organizations meet twice a year in a formal Management Review Committee to review the 6 month history and performance of the system. Its a joke when you think about it. By the time you review the issues and their effect on the system the issues are old and stale. Its a struggle to remember and then you have to take the time to pull documentation if you even decide to take action on an issue. Meeting twice a year for several hours doesn’t accomplish much.
I have found that holding the Management Review Committee every day works great. The meetings are held immediately after the morning production meeting when (more…)
ISO 9001:2008 is not that much different from ISO 9001:2000. There are clarifications, changes in terminology and greater emphasis on basic ISO tenets. A greater emphasis on basic ISO tenets is what we found to be the most important feature. These ISO components affected range from management review, internal audits, vendor audits, corrective actions request (CAR) and preventative actions request (PAR).
Corrective and preventative actions now incorporate a philosophy called (more…)
Its been a while since I’ve had any free time to post anything to my blog. Most of my free time has been spent learning everything I could about ISO 9001:2008. As the Executive Manager of Quality and Engineering at Electropac Co., Inc. www.electropac.com the responsibility to manage our bid for re-certification was mine. We already had a working ISO 9001:2000 system in place. Unfortunately the ISO coordinator responsible for managing our current system had moved on to another job. I had years of experience working with ISO system. However, I never had to coordinate an official recertification initiative. Hence my need for a crash course! To make a long story short, the team and I were able to pass the certification process. Electropac Co., Inc. is now ISO 9001:2008 certified, certificate number US-4174b.
The certification process required (more…)