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Standards such as ISO 9001 mandate documentation requirements as part of a company’s compliance with the standard. Although the requirements are intentionally broad-based and open, many organizations tend to over-document their systems. ISO 9001:2008 requires a manual and six documented procedures. AS9100 requires seven, and ISO 14001 requires one. Yet companies continue to write additional procedures, often for the wrong reasons. Let’s end the confusion about implementing a management system vs. documenting one.
A common belief is that the standards’ requirements are satisfied if detailed procedures exist to define a system. Additionally, many managers and executives think that a documented procedure for every element in the company results in better control and accountability. Although no requirements are enumerated in these standards for procedure format, more emphasis is placed on this than on the information contained within the procedures.
As more companies embrace Six Sigma, the need to
hire and train employees in the methodology grows. One issue facing beleaguered
managers and human resource departments is how to determine whether an applicant
truly possesses the Six Sigma skills required by the company. If he or she has a
certificate, does it have any value? If not, how does your organization verify
employees' Six Sigma skills? Once you get beyond the marketing hype of Six
Sigma, what will really help your organization eliminate or even prevent
problems?
These questions and many more based on your particular needs should be
addressed as you review what you and your organization will accept as qualified
certification.
This article presents commentary on important items that apply to the value
(or lack thereof) of Six Sigma certification in your organization.
Understand your needs
Whether you decide to grow your own Six Sigma
practitioners or hire from the outside, management must understand the role that
it wants Six Sigma to play in the organization. Just stating in a job posting
that a person must be Six Sigma-certified is meaningless unless the organization
knows what it really wants.
Here's the nightmare: You arrive at work to find your best customer has just returned $10,000 worth of precision ceramic parts. They are all neatly boxed and sitting on the inspection room floor with a nasty note saying that they are all out of tolerance. You stand to lose one of your best contracts, not to mention your job, unless you get to the bottom of the problem right away.
So you immediately go to your tool crib and remove your precision digital micrometer from its padded box where it lay with its anvils neatly closed.
First, you check the calibration sticker. The micrometer has a six-month calibration schedule and was calibrated five months ago. No problem there. You check the absolute zero setting on the micrometer. It reads 0.00000". Exactly where you set it when you put a fresh battery in last month. So the micrometer should be OK. The micrometer and the parts have been at the same temperature for several hours, so you should be OK there, too. It's time to check the parts. You remeasure every one of them. They're in spec. All of them.
Optical measurement, when clearly understood and applied, can bring huge benefits. It can also be an investment disaster. To avoid the latter, we need to start with an understanding of the basics--the capabilities and limitations of optical measurement. Then, we can consider the applications where it might provide a better solution over current methods, such as touch probes, optical comparators, hand gauges, or microscopes. Digging deeper, we can discover the challenges that those applications present to optical measurement, the limitations, and the potentials for failure. In this article, we will investigate the optical tools and software strategies that have been developed to meet those challenges. With a deeper understanding, the right technology can be applied to the task, and the investment dollars will make sense.
The basics
The diagram in figure 1 below illustrates the basics of optical measurement: lighting, optics, XY Stage, and a Z axis that handles the focus.
IECQ QC 080000: The Standard for Lean-Green Compliance
Although not all manufacturers around the world understand the value proposition of a lean-green, process-based manufacturing program, there are more than 1,250 that do--those that are registered to the IECQ QC 080000 standard.
IECQ hazardous substance process management (HSPM) has proven to be an efficient, effective, and financially prudent way for manufacturers to demonstrate international compliance with hazardous- substance-free components, products, and related material requirements and legislation.
Adding a lean-green, process-based manufacturing program enhances this concept and adds even greater value.
When properly implemented, QC 08000 certification provides its management and stakeholders:
The term “global” is ubiquitous in our daily lives. Like the economy, human rights, and peace, the environment is often discussed in global terms because that’s the only way to bring about profound change. Now, global warming--even though its full extent is unknown--has brought a sense of urgency to improving the environment.
The International Organization for Standardization (ISO) brings together stakeholders from around the globe to develop international standards that provide structured means to systematically manage improvement. ISO 14001--”Environmental Management Systems--Requirements,” along with a separate guidance document for its use, is the basic environmental management system ( EMS) standard being implemented globally to help manage environmental aspects of an organization. An EMS can be an effective tool in maintaining compliance with regulatory and other requirements, preventing pollution, and driving continuous improvement.
Quality improvement has stalled in manufacturing due to an inability to capture, continuously improve, and leverage performance knowledge in design and manufacturing activities. Other enterprise systems, such as project life-cycle management (PLM), fail to improve quality because they treat it as a process management problem. The fundamental challenges to achieving quality are knowledge-management and continuous-improvement issues. Recently, quality life-cycle management has received a boost from enterprise software solutions designed to change how manufacturers go about designing quality into their manufacturing processes and products.
Some statistics reported by manufacturers highlight the current dilemma in quality performance:
• Eighty percent of all quality issues are repeat issues. These are errors that have happened before and were fixed, yet the lesson learned wasn’t recalled by or communicated to another group so that preventive action could be taken.
The process potential index, or Cp, measures a process's potential
capability, which is defined as the allowable spread over the actual spread. The
allowable spread is the difference between the upper specification limit and the
lower specification limit. The actual spread is determined from the process data
collected and is calculated by multiplying six times the standard deviation, s.
The standard deviation quantifies a process's variability. As the standard
deviation increases in a process, the Cp decreases in value. As the standard
deviation decreases (i.e., as the process becomes less variable), the Cp
increases in value.
By convention, when a process has a Cp value less than 1.0, it is considered
potentially incapable of meeting specification requirements. Conversely, when a
process Cp is greater than or equal to 1.0, the process has the potential of
being capable.
Ideally, the Cp should be as high as possible. The higher the Cp, the lower
the variability with respect to the specification limits. In a process qualified
as a Six Sigma process (i.e., one that allows plus or minus six standard
deviations within the specifications limits), the Cp is greater than or equal to
2.0.
If your company is involved in manufacturing, chances are that a good portion of your company's assets include measurement and test equipment (M&TE). This includes everything from simple go/no-go plug gauges to air-pressure gauges, voltmeters, micrometers and calipers on up to very sophisticated equipment such as robotic coordinate measurement machines and scanning electron microscopes.
M&TE are those assets your company uses to make critical decisions on whether to pass or fail incoming materials, in-process work and finished goods.
Of course, M&TE itself must be periodically inspected, tested and calibrated as part of the quality process. Poor or unreliable measurements result in faulty decisions and questionable product quality. Calibration management software can be crucial to helping maintain equipment accuracy and properly calibrated testing equipment.
Calibration management software saves time, effort and money. Computerizing your calibration records makes them instantly available in the event of product quality problems or a quality system audit.
The last few years have provided ample evidence that control of food safety is critical. Recent media reports have clearly documented supply chain shortcomings that have threatened consumers’ health and safety. These ongoing problems and the need for consumer safety cry out for additional tools to dramatically reduce or eliminate risks.
Milestones in U.S. Food and Drug Law History
1883 Dr. Harvey W. Wiley becomes chief chemist for the U.S. Department of Agriculture. Campaigning for a federal law, Dr. Wiley is called the “Crusading Chemist” and “Father of the Pure Food and Drug Act.”
1906 The original Pure Food and Drug Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. The Meat Inspection Act is passed the same day.
