Three Areas to Improve A Quality System
Why bother improving?
The society of quality professionals is divided into two technical areas: quality improvement and compliance. When Ford invented mass production, the highly skilled craft worker was replaced with interchangeable assembly line workers and the newly created industrial engineer, who guided their work. Since that time, the science of improvement has evolved into a myriad of disciplines including Six Sigma, total quality management (TQM), and Lean manufacturing. Compliance, on the other hand, is altogether different. People working in this area are responsible for maintaining their organization's compliance to a standard. This could be the ISO 9000 series of standards, the good manufacturing practices for food, drug, cosmetic, biological, veterinary food and drugs, radiation-emitting products, and medical device manufacturers, or an industry specific standard like the aerospace AS 9000 standards. Regardless of the standard, the compliance person is usually the designer and maintainer of these quality systems. Typically, certification requires an outside auditor so the compliance specialist is also responsible for coordinating the audits and resolution of the findings. Other duties include educating the organization on the standards, anticipating changes in the standards, and developing resources to increase the compliance knowledge-base. Despite having similar titles, quality engineers, technicians, and managers have very different jobs depending on whether the department is focused on quality improvement or regulatory compliance.
Much to the chagrin of quality managers, executives view these two areas differently. Quality improvement is a revenue generator with the multitude of cost-savings, capacity increase, or product improvement efforts yielding tangible results. For example, if a company pays a Black Belt $100,000 annually, but he or she completes four projects with a return on investment of $125,000, then the Black Belt was not only free, but added $400,000 to the company's bottom line. Executives view this not as a cost but a benefit. They wonder how much more benefit could be achieved if they hired more Black Belts. The compliance field does not have this luxury. Compliance is a binary situation: you either meet the requirements of the standard or not. There is no added benefit to being “more compliant.” Therefore, executives are looking for the lowest possible cost of compliance. If the quality organization has a million dollar budget and obtained ISO certification, then it is a natural extension to contemplate if certification can be retained by reducing the budget by 10% or 20%. This creates a downward pressure on the quality department so that unless the standard changes radically, their budget should be shrinking every year as compliance challenges are found and eliminated.
In reality, most organizations are not fully compliant; the auditor just did not find the problem areas whether through skillful management of the auditor by the quality manager or just poor auditing. Likewise, compliance goals are not static. Changing industry positions, standard revisions, and competitive pressures all tend to increase the compliance goals. For example, the ISO 9001:2000 standard added customer satisfaction measurement from the 1994 revision. This creates a disparity between the quality management's perception and the rest of the management team. While one group anticipates a greater need for personnel and equipment, the other is expecting the exact opposite.
Therefore, it behooves the quality organization to always be improving the efficiency of their operation. Increased efficiency can lead to greater compliance as resources are directed from areas of strength to weakness. Alternately, increased efficiency can be deployed to meet new compliance goals without an increase in head count. Failing a genuine need for more resources, increased efficiencies can be used to proactively reduce total resource consumption through attrition as a third option.
Document Control
The first area of improvement is document control. Document control is often plagued with inaccurate procedures and long review times. In practice, it has been found that each signature on a document increases the approval time by about seven days. For a simple form with five signatures, it could take more than a month to approve a simple change.
By including only decision makers on the procedures, excessive delays can be eliminated. In general, there is only one person per department who has the ability to say “yes” when everyone else says “no”. That is the person who needs to be reviewing procedures. Additional signatories not only adds cost and waste, but portrays the document control department as overly bureaucratic. This will not only reduce the time to approval, but improve the quality as fewer reviewers do a better job than many. When there is multiple coverage, some reviewers tend to do poorer, less thorough reviews. By assuming near perfect detectability, individual reviewers will do less thorough reviews to avoid wasting time and let their colleagues bear the inspection burden. When a significant minority does this, the reliability of the entire system suffers.
Another innovation in document control is the review meeting. For documents with many approvers, it is often easier to schedule a thirty minute meeting to discuss the changes, agree to any revisions, and then sign the procedure right there. Management likes this approach because they already assumed they would spend the day in meetings, and this one actually accomplished something! If changes are required prior to approval, the submitter should immediately process the changes and then return the document to the reviewer for approval within the hour.
Electronic distribution is also useful in improving approval times. Time wasted in copying, laminating, putting in sheet protectors, punching, binding, stamping, etc. is all non-value added work that document control personnel often eagerly engage. There are some departments where people spend all day on the logistics of document control without adding any additional value to the process. Conversely, placing controlled procedures on a company server reduces all of this time to mere minutes as dozens of procedures can be simultaneously distributed over a large plant. As far as security is concerned, there are inexpensive software packages that can provide read-only access to these files to eliminate personal copies. Likewise, with the electronic copy as the official version, there is no need for personnel to hoard paper copies. This also improves quality as giving the operation better access to procedures will increase the possibility of them reading the procedures if they have a question. Difficult to understand or find procedures discourage operators who will then seek alternate sources of information such as their colleagues, supervisors, or a poor memory.
Supplier Quality Management (SQM)
Supplier quality management is a poor fit for quality. Due diligence is the responsibility of the buyer who is not usually employed by quality assurance. Since quality assurance or quality control is not the decision maker, they are often put in the position of deal breaker. Many times, it is unclear which standards to apply to some suppliers, like service providers or distributors. Finally, supplier quality management relies primarily on quality engineers or managers to coordinate the supplier qualification although their skill sets are not optimal for this role.
Not surprisingly, adopting a standard is the first step towards improving SQM. ISO 9000 is a convenient choice if that is suitable for an organization. The important aspect is for executive management to understand that this is a reject / accept criterion for a potential business partner, despite their lower costs. This will improve quality as supplier auditors and buyers have a clear understanding of the requirements rather than a subjective opinion where approval is nothing more than a rubber stamp. If a published standard is not available, then a modified one is best in most instances. Truly original standards are often too complicated for suppliers and auditors to follow.
Another good practice is the auditing of systems and not products. Supplier quality engineers are particularly fond of getting a sample of product to perform process capability studies. Unfortunately, the representative sample may have been made by the best engineer, using the best equipment, with hand-picked raw materials. The variability is minimized by culling out any defective product so the prospective supplier is putting his or her best foot forward. When an order is made, the second shift technician using typical raw materials with the temperamental machine fills the order, the product quality is mysteriously terrible and everyone wonders how a process that had a process capability index of 1.66 during qualification now has 10% rejects. By auditing the systems, good product is assured by verifying the company has processes for inspection, segregation, manufacture, and control. If the company has already determined the optimal running parameters for similar products and can show that they are running within those parameters, then a supplier quality manager can have greater confidence that they will do the same for them.
Truly breakthrough quality can be achieved by developing a relationship with the purchasing function. Purchasing agents, buyers, etc. are often not engineers or have had any quality systems training. While they understand prices, negotiation, and contracts, they are really left in the dark about how to evaluate the product quality. Unless the industry has published some unbiased assessments, there is little recourse for the buyer. With early involvement in the process, quality managers can provide value to purchasing by giving them detailed information about the processes within the potential supplier. Instead of being the last to know, a relationship with purchasing will mean quality management will be the first to know of opportunities as made aware to them. This knowledge enables the buyer to accurately access potential suppliers based on both their cost and quality. Nobody wins by selecting a supplier who cannot meet the standards.
Corrective Action
Corrective action is the third area for improving a quality system. This is the most important as it repairs all of the other systems, so even if the quality system is poorly conceived, a robust corrective action system can compensate. Because of this, the two most common problems with corrective action systems are ineffective actions and long completion times. When errors take forever to resolve and the same errors crop up every couple of months, then the corrective action system is to blame.
The first improvement that can be made is implementing a robust system of verification. If many solutions are not correcting the problem, this can be quickly seen by auditing or verifying that the solution works. For example, if an inspection is implemented to curtail defective product coming off a machine, a reasonable verification would be to take a sampling of the parts post inspection and expect to find significantly lower levels of defectives. If the inspection does not show any improvement, then the inspection and therefore the corrective action was ineffective and must be re-considered.
Key to successfully implementing an improved corrective action system involve only decision makers in the closure process. Since most failures are system driven, individuals with the authority to change the system should be responsible for completing the corrective action. For example, if a process generates 10% defects and the root cause is a bad supplier, a technician probably does not have the authority to switch suppliers, so making him or her responsible for correcting the problem is silly.
Another idea for improving the corrective action system is to collate all of the individual failures into fewer system failures. This not only reduces paperwork, but it creates a more realistic view of the problem. Many corrective action systems are too rigid in their approach and insist on every defective part or component as a separate failure. This encourages quick fixes and remediation rather than true problem solving.
Conclusions
Compliance is going to be a fact of life for many years to come. As industries go global, there will be increased efforts to harmonize and standardize companies to international standards. While these compliance efforts will increase the cost of doing business, the lean quality organization will be best prepared to meet the challenges ahead.