NORWICH, CT, October 24, 2008
/24-7PressRelease/ -- On a recent flight to California, an operations engineer answers his cell phone that rings upon landing. The conversation that can be heard by everyone is as follows:
"Hello? What do you mean it failed? What failed? Hello!" Indistinct voices can be heard emanating from the cell phone. "Slow down! Again... uh huh.... uh huh... so no one issued a change control? You just 'hot fixed, it?!?" More indistinct voices are heard. "Well if it gets the product out on time I guess it is ok. What does the manual say? What... uh huh... where is the manual?" The indistinct voices sound like bees buzzing. "You don't know? Do you know what it looks like? When was it last updated? How many years ago?" The questioning along the same vein continues as the engineer exits the plane.
So begins the investigation of a production line failure. Teams will be gathered and investigations initiated. Data will be analyzed, reports written, and corrective proposals made. The beginning of a CAPA process. Understanding the nature or root cause of the problem will be looked at with great detail. One item should not be lost in all of this, what about the documentation?
Product failures can have a number of reasons: poor design, poor raw materials, and poor documentation. A CAPA needs to consider if the documentation around the product is written clearly in a language that is easy to understand by everyone within the company. If a work instruction is too difficult to grasp by the end consumer of that information, then a factor of failure has been introduced. Just think of all those toys put together from Christmas that have confusing instructions and end up with spare parts that belong somewhere.
A great example of misunderstood work instructions is the United States Army in the nineteen seventies. At the time a newly volunteer army had many soldiers that did not complete high school and in some cases could not read above a fifth grade level. Meanwhile maintenance documentation for vehicles were written by technical writers that had a college level education. Those writers were writing to the wrong audience. Repair times suffered and many units were borderline combat ready. After careful investigation the Army realized the problem and issued manuals in a comic book format that was easy to read, light to carry, and got the basic important information across to its soldiers. The Army also introduced a program to improve recruiting and get its current soldiers an education. The result: a higher pass rate for vehicle maintenance and an improved combat readiness rating. Not to mention an educated military.
Today companies have the ability to use software to control their documents and their CAPAs. In many cases companies have one software system for CAPAs, one for their quality documents, and one for their change control processes. Ideally a company, and from an IT management prospective, one software system should be able to handle all of those key quality functions. A quality manager or production engineer can quickly discover when the last work instruction was made, who made it, who has read it, and if it has ever been part of CAPA before. This is the hallmark of great document control and a great CAPA process. Any software system should at least give the company that basic information. Some software systems allow you to test the comprehension of your employees. This is valuable information, based upon their grades you will know if they understand what has been written for them and if the writers are authoring to the correct audience.
Documents are the lifeblood of any company. CAPAs are the means to learn from failures and plan for success. Both are tied closely together. Not appreciating that can lead employees to feel as if things are repeating themselves as the same failures rear their ugly heads. Not understanding what is required of them by the documents written; employees will cut corners not out of spite, but to get the job done.
About Mystic Management Systems, Inc.
Mystic Management Systems, Inc. is a twenty-five year old leading global provider of quality software solutions, including document control software, product lifecycle management, packaging/specification management and corrective and preventative action. Using applications from Mystic Management Systems, companies throughout the world have been improving profits, reducing costs, and producing better quality products since 1983.
Worldwide: (01) 860-887-2900
http://www.mysticmsi.com
info@mysticmsi.com
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