Internal & External Factors Clause 4 of the new standard requires that an organization must determine what issues and requirements will impact planning and quality. To establish the context means to define the external and internal factors and must consider when and how they affect quality. The internal context may include: Your products and services […]
Where to Start? First, you need to determine which of the new requirements are already being satisfied in your existing quality system documentation (whether a formal certified QMS or homegrown), because some of the requirements scattered throughout ISO 9001:2008 are now consolidated into this new clause. If you have already implemented ISO 9001:2008, then you […]
Making the Simple Complex With each iteration of ISO 9001, the powers that be seem bent on developing one requirement using verbiage that makes a simple concept complicated to understand. For the 2015 version of ISO 9001, Context of the Organization is it. They can certainly take a cue from my friend Tom Peters when, […]
The new ISO 9001:2015 standard is now released and is quite a departure from the 2008 version. While the official drop-dead date to be fully compliant and certified is not until September 2018, this will come much faster than you think. Now is the time to begin the transition from your 2008 QMS to the 2015 version. These changes can […]
The goal of root cause analysis (RCA) is to find out what really happened, why it happened, and how to prevent it from happening again. Chasing symptoms instead of digging deep to find root cause will almost certainly guarantee that the problem will repeat. Peeling back the onion, layer-by-layer, can be a long and tedious […]
One of the most frustrating parts of a customer’s life is dealing with a performance issue that hasn’t been properly addressed at a supplier. A company can have all of the most effective Quality Tools at their disposal, but if not used properly, they will see little benefit. Most companies have some form of a […]
Plan-Do-Check-Act Cycle (PDCA): This is more of a quality methodology that employs a four-step model, which seeks continuous improvement by combining constant evaluation of management policy and procedures with statistical analysis. The PDCA model was developed by Dr. Walter A. Shewhart and was later refined by the good doctor’s most famous student; W. Edwards Deming. […]
Failure Mode Effects Analysis (FMEA): This is another of those “scary” quality tools that people often don’t utilize strictly because they don’t really understand them. A Failure Mode Effects Analysis is simply a step-by-step attempt to identify all possible failures in a product, design or process. If it is being used for a process it […]
Pareto Analysis: Around the turn of the 20th century, Italian economist Vilfredo Pareto made a couple of observations that led him to develop a principle that continues to be a powerful problem-solving tool today. He observed that around 20% of the Italian population owned approximately 80% of Italy’s wealth. He later observed that about 20% […]
5 Whys: This technique can be used very effectively during cause & effect analysis to drive to true root cause. Anyone with small children has first-hand experience with this problem-solving tool, although in the business environment root cause should not end at “Because I said so!” Although the word “Why?” may be your three-year-old’s favorite […]
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