by Lance Coleman
The ASQ Certified Quality Auditor Handbook states that an audit program should ensure compliance, help manage risk, and drive continual improvement. In reality, the audit program is often focused, at upper management’s directive, on compliance and correction. In part one of this series, which appeared in The Auditor’s September–October 2012 issue, we discussed risk-based auditing. This article will outline how the audit program can help drive continual change. Although there are several ways to accomplish this goal, I prefer the use of lean tools incorporated into the audit process.
Lean tools can be integrated into an established audit methodology to develop a more robust, value-added, and continuous improvement that drives the internal audit program. Accomplishing this integration will allow the following:
- Lean tools give auditors the ability to drill deeper and wider to look for weaknesses in business systems in addition to noncompliance to the quality management system (QMS).
- The audit function acts as a lens for the lean program, thereby improving results.
So what exactly is lean?
Based on the Toyota Production System and used in hundreds of thousands of organizations across the world in the last 30 years, lean is a set of management practices that organizations utilize to improve efficiency and effectiveness. Lean utilizes a set of tools or methodologies to identify and eliminate nonvalue-adding activities and waste from an organization’s processes. In other words, companies can do more work, in less time, and with less cost through implementation of lean methodologies.
This improvement is accomplished by identifying and reducing seven specific types of waste in your operations. The seven wastes lean focuses on are:
- Waiting. Time is money. Waiting ties up resources that could be more profitably engaged, whether that resource is a person who could be doing something else or a part that is waiting to be transformed into a more valuable asset.
- Example: Waiting online or holding on a phone call. Having the second step of a process slower than step one so that parts begin to pile up.
- Inventory. Although it’s necessary to have enough inventory to “wet the line” when production of product (initiation of service) begins and to fulfill reorders, having an overabundance of inventory that could potentially expire, or be lost, become damaged through excessive handling or movement is a form of waste.
- Correction. The cost of catching and correcting errors as well as replacement of items or materials and possible reduced value to the customer are all part of the waste of correction.
- Example: Defective parts, improperly completed forms, customer returns
- Conveyance. Unnecessary movement between locations takes up time, energy, and can lead to other forms of waste.
- Motion. Having an inefficient workspace is considered a form of waste because it can lead to lost time, hinder communication, impede effectiveness, and, worst of all, potential injury.
- Overproduction. Producing a product or service that cannot be delivered when complete is a form of waste. This inventory represents time, materials, and other resources that have been invested that cannot be compensated for while undelivered. Physical products take up space in the warehouse that would otherwise be utilized in a more productive way. The ideal scenario to work toward is to produce and deliver a product or service just as the customer is requesting it.
- Example: Warehouse inventory takes up space, may need to be moved around, could possibly degrade, and represents a financial investment that cannot be recouped until after shipment.
- Overprocessing: Overprocessing has two components: taking more action than is required and actions that have no additional value to the end customer.
- Examples: Having two plastic liners for parts where only one is required. Maintaining a higher-than-mandated acceptable quality level (AQL) level when data show that it could be lowered.
There is also a newly identified eighth waste: underutilization or sub-optimization of resources (personnel). This will be the topic of another discussion.
The auditor’s toolbox
After the process owner and the process stakeholders, who better than an auditor to identify waste in an operation? The auditor is also uniquely suited to identify best practices that might be transferable across departments, functions, or even different locations. There are specific tools in the lean toolbox that lend themselves well to use by auditors as a part of continual improvement efforts. Let’s take a look at just a few of them.
Value stream mapping (VSM)
When conducting a quality audit, it’s customary to map the process in preparation; match documents and procedures to regulations/standards; match employee actions to internal documents/procedures; and verify appropriate training, operating controls, environmental controls; and recordkeeping, at a minimum. Additionally, an auditor might look to identify best practices and opportunities for improvement.
Incorporating VSM into an audit adds another level of analysis. Which actions are value-add and which are not? Are value-add actions optimized and nonvalue-add actions minimized? How efficient are the feeder value streams that flow into the primary value stream that is being audited? Where are the potential bottlenecks in the value stream flow? What are the feedback loops used to monitor and evaluate the effectiveness of the system under review? How close are we to matching product cycle time to takt time? All of this allows us to identify waste in the system while simultaneously providing for a more robust process review.
Control charts are a huge opportunity for auditors and they require substantial statistical knowledge. In the medical device field, it’s a comcommon requirement to report out-of-specification/tolerance conditions to the area supervisor—so much so that there is a commonly recognized acronym (OOS/OOT) for this practice. However, you would be surprised how infrequently it is required to report out-of-control—as opposed to out-of-specification or out-of-tolerance—conditions. There are trends of vacillating or drifting processes, such as 14 data points alternating up and down, seven consecutive data points above the mean, or six or more data points ascending in value. Similarly, it’s even less common to have other unusual trends reported.
During audits I have actually seen a 0.05″ measurement indicated as meeting a 0.050″ maximum requirement. The obvious issue is how do you know the dimension is in spec without knowing the third digit? Besides a possible compliance issue, there is a possible training opportunity or a need to improve a piece of equipment with insufficient resolution for the measurement that it’s being used to take.
Supplier-input-process-output-customer (SIPOC) diagrams allow for a much more detailed analysis of data than the traditional flowcharting or process mapping done during audits. Knowing where inputs come from (what shift, what production line, which supplier, etc.) is as valuable in looking for trends and determining root cause as is knowing what the process inputs are or should be. Knowing not just the expected process outputs, but also the customer for those outputs provides insight into whether requirements meet end user needs and expectations. In other words, knowing all of the outputs that are expected doesn’t always guarantee that the item produced will function as desired.
One simple example of this would be a part that meets specification but sometimes doesn’t connect properly with its mating part. One way to address this issue might be to tighten tolerances of one or both parts once this issue is discovered. By matching process outputs to customer (internal or external) needs and expectations we can often identify unforeseen improvement opportunities and thereby provide additional value to the customers.
When they take a lean approach to auditing, auditors can identify process waste while simultaneously looking for noncompliance. This can be done seamlessly without having to do “separate but equal” compliance and improvement auditing. Lean auditing will lead to increased effectiveness of the audit program because responses to identified noncompliances will often not stop at just correction and prevention, but also actively seek to improve the process. Lean auditing will also lead to greater visibility of the audit program by allowing for more opportunities to positively affect the company’s bottom line.
In conclusion, incorporating lean into your audit methodology will not only greatly expand the versatility and effectiveness of the audit process. It will also give auditors the opportunity to practice what we preach during our 2013certification training, as we boldly head deeper into the 21st century.
About the author
Lance Coleman is a quality engineer and lean leader in Tempe, Arizona, who has worked in the medical device, aerospace, and other regulated industries for more than 15 years. He has a degree in electrical engineering technology from the Southern Polytechnical University in Marietta, Georgia, and is an ASQ senior member, a Certified Quality Auditor, and a Certified Biomedical Auditor. Coleman has been previously published in Quality Progress magazine and other industry periodicals. He also serves as the ASQ Lean Enterprise Division publications subcommittee chairman. He can be reached with comments or questions at firstname.lastname@example.org or www.fullmoonconsulting.net.