by Thomas A. Gray
I recently had an interesting conversation with an assessor for a third-party registrar that got me thinking. The assessor was auditing the internal audit program at a client that had contracted me to manage the program. The assessor was reviewing our program vs. ISO/TS 16949. He’d reviewed the schedule for all of the process audits and was moving on to review the internal audits to meet ISO/TS 16949’s requirements for manufacturing process audits and product audits.
The company had been recently audited by General Motors (GM) to meet its Quality System Basics requirements and had created a layered process audit program to meet GM’s requirements. The internal audit procedure had been revised to show that a layered process audit was the method employed to meet both the manufacturing process audit and product audit requirements. During the review, the assessor, who was happy with the information he was reviewing and offering a number of very helpful opportunities for improvement for the internal audit program, said to the group assembled, “You know, if I was running an internal audit program, I would choose an auditor once a week and send him out to audit an area in the plant where I’m having the most problems.” I suggested that that was the goal of the layered process audit, but he was adamant that his suggestion was “bigger than that.”
I found myself reflecting on this statement for weeks after it had happened. I remembered back in 2001 having many conversations with other quality practitioners about the changes to internal auditing as a result of the process approach required by the 2001 revision of ISO 9001. The general consensus then was that audit programs—in adapting to this approach—would create audits that were more in depth, take longer to complete, and be performed less often.
I know some organizations that, as a result, perform audits for an entire site only once per year and spend the remainder of the year working through action items resulting from the audit. I reflected that I have never subscribed to either the belief that process audits would take more time or that companies should perform internal audits at a site only once per year. This approach, though it meets the requirements of ISO 9001, never struck me as a process that helped the organization continually improve its processes.
I also found myself reflecting on another topic of conversation that I have with many of my clients. It’s a conversation that basically goes, “Here is a new program (lean, Six Sigma, etc.) that we want to implement, and we need to transform our culture for it to be successful.” I have always found these conversations to be interesting. The client is usually looking at the program as a panacea—if only the folks on the floor would “buy in” to the program, the culture would magically change for the better and all would be right with the world. I, on the other hand, don’t believe that implementing any new program will necessarily change the culture at any company. I am of the firm belief that cultures change based on the ongoing actions that take place by all of the members of the organization. If you want to change the culture, then you have to change the actions that people in the organization are required to take. This in turn will change people’s behaviors, which in turn will over time change people’s habits.
Based on what I was thinking about, I was beginning to formulate an idea. I don’t think it’s a new idea nor do I think that it has never been used, but I have not seen it used often. It’s based on the premise that consistent auditing by many members of an organization can help to drive both continual improvement and transform the culture of the organization. The idea would be to use all of the tools available to an organization and create an internal audit program that emphasizes quick, focused audits focused in areas where there is the greatest number of issues or the process is considered the weakest. Such a system would create new behaviors and habits by a large number of employees in the organization. In effect, the idea of the layered process audit is to create an audit program where there are a lot of little audits.
To begin, I did an accounting of the tools that could be used for this kind of program. I found that many organizations use a lot of different tools without integrating them. For example, I found that there were Pareto diagrams for quality issues, 5S checklists, preventive maintenance checklists, and layered process audit checklists. All of these tools are used above and beyond the quality management system’s (QMS) internal audit schedule and in many cases they aren’t coordinated with one another, causing the perception that each of these programs adds burden to everyone.
Table 1: Tools for use in audit program
|ISO 9001 internal audit checklists||Review of process-related issues within the organization, including inputs, outputs, resources, and measures of efficiency and effectiveness|
|TPM/PM checklists||“Cleaning is inspection” used as a method to have the operator look at and identify equipment issues|
|5S daily audit/checklist||Method to identify issues with organization that can cause excess downtime, lead time, or quality issues|
|Layered process audit checklists||Method to verify important process issues that may cause quality issues and customer dissatisfaction|
|Pareto charts||Method to identify high-priority issues within the organization or a problem area within the organization|
|Control charts||Statistical process control method to identify issues where out-of-control situations may occur|
|Standard work documents||Document to identify process parameters that are critical for a process and should be audited. Can be set-up instruction, operating instruction, customer requirements specification, etc.|
I decided that the layered process audit approach was the best choice for the audit program architecture. Some information from the ISO 9001 internal audit checklists could be used within this approach, but these audits could be left untouched. The existing layered process audit checklists, along with the 5S and total preventive maintenance (TPM) checklists would be reviewed and combined into a single set of audits used in each area. The charts and diagrams in the area were tools that can be used to fine-tune the audit checklists with high-priority checklist items.
With the layered process audit approach, the initial focus was on the first two layers. Layer 1 would be a daily audit on each shift performed by the operator or technician in the area. The layered process audit checklist in this layer could either be the same each day or rotated with different items checked each day. The operator or technician would be empowered to take immediate action for issues found during the audit. Operators or technicians performing the audit would be rotated each week, giving everyone in the area the responsibility to review important characteristics of process performance for the area.
Layer 2 would be a daily audit by the area supervisor to review the results of the shift audits, including issues identified with the layer 1 audits. Supervisors would be taught to speak to the layer 1 auditor regarding any issues and actions to be taken to close the issues. Supervisors would also be taught to review the layer 1 audit to ensure that the operator or technician did not “pencil whip” the audit. The method taught to the supervisor would be to review some of the checklist items to determine that the answers to the checklist items were accurate. More layers to the audit system would be added with agreements with managers and other departments, such as engineering and quality. For example, a layer 3 audit conducted weekly in each area could be performed by the quality representative assigned to the area and a layer 4 audit could be performed by the manufacturing engineer responsible for the area. These audits would be of a higher level, concentrate on issues of nonconformities and process control, and used as a method to communicate issues from the process to these managers.
Table 2: Layered process audit strategy
|1||Operator/technician||Direct issues such as set-up, process parameters, TPM, 5S, etc.|
|2||Area supervisor||Review layer 1 completion and issues.|
|3 & higher||Manager||Review issues of quality nonconformities and process control.Communication method of process issues to managers|
The result of this system is evident. For a third-shift operation in an area with the layered process audit approach, there will be 20 audits each week (15 audits in layer 1 and five audits in layer 2). The auditors would be reviewing issues related to organization (5S), TPM, and quality. With operators, technicians, and supervisors empowered to quickly take action when issues are uncovered, processes will be kept in control and continually improved. Finally, with the new habit of auditing the process each shift and by everyone in the area, new habits and behaviors are established by all who work in the area. These habits include discipline in following process instructions, keeping the area properly organized, solving issues that could lead to nonconformities quickly and effectively, and effective communication from operators and technicians to supervisors and from supervisors to operators and technicians. These new habits will result in the transformation of culture that most companies strive to create.
Table 3: Layered process audit metrics (Based on five work days per week)
|Layer||No. shifts||No. audits|
|2||1 – 3||5|
For a three shift, five-day-per-week process, the organization would see the process audited 1,040 times in the year through the layered process audit approach. With everyone involved and trained to use the layered process audit checklist and supervisors willing to communicate with the operators and technicians performing the audits, a culture of professionalism and open communication can be created. This certainly could be a system where any company would reap a benefit.
About the author
Thomas A. Gray has a master’s and a bachelor’s degree in chemical engineering. He has extensive experience in quality and operations management, having worked 15 years supporting the automotive, aerospace, and health care industries. He has assisted numerous organizations gain compliance and/or certification to various quality management systems, including ISO 9001, ISO/TS 16949, AS9100, and ISO 13485. He has developed and implemented successful lean manufacturing programs for manufacturing and service organizations, including the implementation of manufacturing cells, cross-training of self-directed work teams, and deployment of kanban pull systems.
Gray is a facilitator, project manager, and designer of learning/training events. He has served on several local and national committees promoting the development of quality systems and best practices. In March 2002 he founded Productivity Improvement Network Inc., an organization dedicated to helping companies gain continual improvement through training and consulting services.
Tags: layered process audit.