Focusing only on procedural writing for a Quality Management System will result in slower processes, re-work, and an overall uneconomical system:
Quality Management Systems, such as ISO 9001, serve as the foundational building blocks for an organization and provide well defined and documented procedures which improve the consistency of outputs. Yet, the Quality Management System alone cannot accomplish a system of closed loop corrective actions and instituted lessons learned.
A clearly defined and successful Lessons Learned Program will lead to the development of a closed loop corrective action system. Without this closed loop, there are no true lessons learned. Imagine the list of 5000 items on an excel sheet, titled “Lesson Learned.” As with any business, time is money. How can it be cost effective for an individual to spend hours sifting through a bulky excel sheet. It cannot and is not. Capturing the essence of the lesson and identifying communication channels is the key to closing the loop.
Proper investigating and reporting of mishaps (safety incidents, equipment failure, quality issues, etc) will actually be the driving factor for the successful Lessons Learned Program. This can only be achieved through the use of proper incident investigation and advance root cause analysis. Because without the identification of the true root cause, what is the lesson that is to be learned.
Reporting criteria for mishaps must be established to allow for proper screening. Without the screening criteria set, there will be no consistency in the process. Consistency can only be achieved by a well defined and documented process.
Investigation is the next key step to the successful Lessons Learned Program. The utilization of an advanced root cause methodology will drive you to the true root cause of a mishap. Advanced root cause analysis, such as TapRoot or Reasons, allow the user to utilize a systematic approach for finding the true root cause, so that corrective action can be initiated and the lesson truly “learned” and fixed.
Lesson Learned can be a very extensive and lengthy process to establish. But there is one approach that can be taken to alleviate this issue. This approach is what businesses should consider in developing all documented processes, procedures, and workflows. This approach is Lean Six Sigma. Alone Lean initiatives will not accomplish this, nor will Six Sigma alone. Together they can build the most cost effective and efficient Quality Management System.
As with the development and maintenance of all Quality Management Systems, processes are evaluated and documented. Consider first Six Sigma, which seeks to improve the quality of process outputs by identifying and removing the causes of defects. In order to establish a clear effective procedure, potential for defects must be considered. This consideration will lead to the development of processes and a system that seeks to eliminate the defects. Secondly the Lean factor focuses on eliminating non-value added “waste” in the process. This elimination will lead to efficient procedures that reduce the overall process cycle time which will improve delivery performance and will most importantly reduce costs.
The effectiveness of a Quality Management System is overall dependent upon the ability to effectively establish and document procedures:
- Without effective documentation, you are left open to a redesign of the process every time it is performed. Effective documentation will allow for monitoring, managing, and improvement.
- Monitoring, measuring, and improvement will be accomplished with the well built Lessons Learned System.
- All of these must be created in parallel.
- It provides a unique approach to creating a system that will be successful.
- The reality is that most will take a one way approach.
- This may be somewhat successful, but in order to drive a system that does eliminate defects and potential defects one must consider all.
- Without a Lean Six Sigma approach there is no true evaluation of what will create a Quality System that will eliminate the possibility for defects.
- Without a Quality System there is a loss of consistency, time, and money.
- Without out a true system of Lessons Learned there is no true path on closing the loop on any mishap or corrective actions.
- Without advanced use of a Root Cause Methodology one may never be able to drill down to the true root cause, leaving the possibility of repeat failure.
The best possible avenue in the development of the required principles and tools of a Quality Management System is to utilize a professional team of individuals experienced and trained in Lean Six Sigma and Advanced Root Cause Analysis. This experience coupled with vast ISO Quality Management System and Systems Auditing experience will lead to successful project implementation and completion.
QUALACO, Inc is a business process improvement company grounded in Lean Six Sigma principles and Total Quality Management. QUALACO brings their unique approach into organizations to guide and assist in implementing an entirely successful Quality Management System; a system custom designed to meet the needs and requirements of the organization.
“QUALACO, Inc is committed to providing quality services which conform to customer specifications; completed in a cost effective manner with on time delivery”
ABOUT THE AUTHORS
Marie Giordano is the co-founder of QUALACO, Inc., a Total Quality Management Consulting firm, specializing in process performance Improvement. She manages the direct daily business operations for the firm, and is directly responsible for managing its client base and overseeing projects that directly relate to Process Performance Improvement, ISO Systems Development, Supplier Quality Audits, and Root Cause Analysis Program Development. Mrs. Giordano is highly educated and experienced in advanced root cause analysis methodologies.
Lori L Lyerly
Lori L. Lyerly, MBA is the co-founder of QUALACO, Inc., a Total Quality Management Consulting firm, specializing in process performance improvement. She manages the direct daily business operations for the firm, and is directly responsible for managing its client base and overseeing projects that directly relate to ISO Systems development and maintenance for all ISO Certification types, Supplier Quality Audits, Internal Auditing Systems & Training, and Statistical Process Control Development. Ms Lyerly is a highly educated and experienced in Quality Control Management