World Class Quality Systems

Tuesday, January 31, 2017

The 3 Underlying Risks of Documented Quality Systems

If you have ever participated in, performed, or been audited by an internal auditor or 3rd party registrar in relation to a documented quality system, you have most likely encountered a dreaded nonconformance. A short list of examples of these nonconformances that we are all familiar with include but are not limited to: The revision on the control plan does not match the revision on the work instructions, the operation number on the pfmea does not match the one on the control plan, employee training records do not match the change level of the procedure, the released document is not the latest approved level, the instructions do not provide enough information for the employee to perform their duties consistently or correctly, or the control plan does not match the latest drawing or engineering release level. When similar nonconformances are found in your organization, what are your auditors really telling you? Maybe a better question is, “Why don’t the auditors know what they are telling you?”

Let’s explore these nonconformances from a different point of view. When you break them down, most all nonconformances in a documented quality system can be broken down into three distinct categories. Each of these categories can be viewed as risks within your documented quality system and each may be targeted for risk reduction focusing on the failures rather than the results of the failures. These three categories are as follows: Inconsistencies, Inaccuracies, and Inadequacies.
Inconsistencies within your documented quality system can normally be reduced by focusing on technology. An example of this can be seen in companies that use Excel, Word, PowerPoint, etc. to document their control plans, work instructions, and other controlled documents where the documentation contains multiple entries for the same data. If a company has several documents that must be updated when changes occur, the opportunities for failure increases immensely. However, a database driven system that requires only one data entry field which is shared between all related documents greatly reduces those inconsistencies.

The risks for inadequacies are most commonly associated to training. If your auditor asks an employee a question they cannot answer, he or she must assume that the system they are auditing is inadequate to provide that employee the information necessary to perform their assigned duties at the expected level. When we discuss training at this level, we are also including the training of the management team responsible for setting up the quality operating systems and knowing what must be included to assure that the system is robust. Many times, assuring that job functions, responsibilities, and expectations are fully outlined in the job descriptions can assist these efforts.

The final risk we will discuss is inaccuracies. Inaccuracies, in some cases, can be driven by technology (as mentioned above for inconsistencies), training (as mentioned above for inadequacies), and discipline. For our purposes here, we are going to focus on discipline since both inconsistencies and inadequacies should be targeted for risk reduction prior to inaccuracies. Once both inconsistencies and inadequacies are properly managed, you will find that most inaccuracies will be caused by discipline issues. Discipline includes the commitment from the management team to provide the time and resources necessary to achieve the desired results. To target inaccuracies related to discipline, we need to look at the structure of the quality operating system and ask if the system is designed to eliminate the possibility of inaccuracies from occurring. The discipline to design a robust system, implement the system, provide the training necessary, and then hold employees accountable are the risks to be managed in order to reduce or eliminate this type of failure.

As most Black Belts will tell you “Variation is the enemy”. This phrase is not confined to the manufacturing process. By reducing the variation in your documented quality system by assessing the risk for the three categories listed above and then focusing on reducing these potential risks, you will find you can gain substantial progress in realizing a world class documented quality system.

Saturday, January 28, 2017


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