Originally Published MDDI November 2001
ECO Process Improvements: Making a Change for the Better
Streamlining engineering change-order processes can increase quality, reduce burdensome paperwork, and get changes made more quickly.
Gregory Lanides and Karen Watson
As medical device and diagnostic companies grow and mature, so do their processes and products. As a result, the information these companies must manage becomes more voluminous and complex. Given this common occurrence, how does a company keep its processes, materials, and procedures consistent? And how does it maintain that consistency while improving its products, complying with regulatory requirements, and providing good customer service?
Part of the answer is to implement an effective engineering change-order (ECO) process. Proper management of ECOs is critical to maintaining quality, accuracy, and efficiency of processes and products. A poorly managed ECO process results in wasted materials, customer product returns, and random changes to products, among other things.
For the purposes of this article, an ECO is an order to change any process, procedure, document, material, or piece of equipment within a company, no matter how small or large the change. Unfortunately, a poor change-order process will make even the small changes seem big and in some cases create more difficulties than it solves. To begin changing their ECO process for the better, companies should make themselves aware of common problems with ECO processes, identify and analyze those problems within their own process, adopt ideas for improvement, and then implement those ideas.
ASSESSING THE STATUS QUO
If a company's ECO process is not running smoothly, all that's needed to pinpoint the major problems is to talk with those who are the most involved. Feedback such as, "I dread all the paperwork I need do in order to process an ECO," or "Changing a typo in a desk procedure and changing a major assembly procedure on a device take the same amount of work and time to complete," is common. Employees from various departments should be interviewed to get their unique perspectives. Some specific, helpful queries include, "What do you need from the ECO process? How do ECOs affect your day-to-day work?"
Once the inquiries are complete, a company will have quite a laundry list of problems and issues that need to be resolved. The interviewing process not only highlights potential improvement areas, but brings more people into the improvement process, which is critical to effective change management.
Process Analysis. As with any improvement initiative, a company seeking change must understand its current situation to determine the work needed to arrive at the ideal one. Creating a basic map of the current ECO process as outlined in the standard operating procedures (SOPs) is a good start, but it isn't enough. A company should sample a number of already completed ECOs, making sure the sample represents the variety of ECO types the company processes (if proper categorization of ECOs doesn't exist, that is also a problem). Companies may also want to trace change orders that are just beginning the process to determine their paths. Only by closely studying its current process will a company be able to determine what is really happening.
To the greatest extent possible, companies should try to find the reasons for any discrepancies between the theoretical process (as outlined in the SOPs) and that actually being performed. Perhaps individuals are skipping the more cumbersome steps or unnecessary iterations are being made to the ECOs. Maybe the orders are simply sitting on a key executive's desk for too long. Getting to the root causes of these problems will help identify key improvement opportunities.
|Figure 1. Performing an x-theoretical analysis highlights the process steps causing the most problems.|
(Click to enlarge)
Another useful tool is x-theoretical analysis, which highlights the steps that are causing the greatest ECO-processing delays (see Figure 1). After mapping out the ideal theoretical process, a company must determine the theoretical time for each process step. These times are then compared with the actual process-step times taken from a sample set of ECOs. The ratio of the actual to the theoretical is the x-theoretical ratio. The higher the ratio, the worse the performance of that step.
In Figure 1, the sample analysis reveals steps four and seven as the least efficient in terms of process time taken. A good rule of thumb for assessing the cycle-time proficiency of an ECO process is: less than 10x-theoretical is excellent, 10x to 30x is average, and more than 30x is poor.
Resource Problems. Any process, whether manufacturing or business, requires adequate resources for its implementation. While it is not unusual to search for constraints and bottlenecks in a manufacturing plant, such searches are less common in the office environment. Like manufacturing work in progress, ECO paperwork travels from queue to queue and desk to desk waiting to be dealt with. Surprisingly, business processes are usually less predictable than manufacturing processes, and people are often busier than machines. Company managers should keep in mind that as a person or department takes on more work, the amount of time that work will spend in queue will increase exponentially. A highly variable process takes even more time. Resources that are given work taking more than 85% of their available time will generally have a very high x-theoretical ratio for their respective steps.
What this means is that a basic resource analysis—i.e., an assessment of the time required of a resource compared with the time available—is needed. Constant assessment of resource load is very important, because a high load can cause long lead times for otherwise efficient processes. Those performing the assessments should always account for standard inefficiencies, such as interruptions to normal workflow, when determining how much work a person can really do.
Another load issue frequently appears at the approval stage. Because approvers are typically senior personnel with a great deal of responsibility and little time on their hands, ECOs often sit on their desks for weeks waiting for approval.
Quality. There are two quality elements involved in evaluating an ECO process:
- The nature of the changes (are they really making things better?) and the soundness of the supporting analyses.
- Second, the accuracy, thoroughness, and compliance of each ECO document.
Evaluating the first element is a subjective process. One way to determine the nature and soundness of an ECO process is by looking at the number of change orders that are rejected. Another is to notice how often ECOs are sent back for further analysis or validation. If these numbers are high, it is likely that the ECO submitters are not carefully thinking through their proposed changes. A third method is to poll the ECO approvers for their opinions of the typical worth of the proposed changes that come across their desks.
The second quality element is easier to evaluate, as documentation groups often track the amount of erroneous or incomplete paperwork coming through their areas, and they use checklists to ensure that they don't process incomplete paperwork or noncompliant documents. If no such checklist is available, one should be drafted as soon as possible.
Too Many Cooks. One very important issue to weigh is the number of people reviewing and approving ECOs, regardless of the subject or criticality. Sometimes, too many individuals want to become involved for fear of missing something that will affect them, or someone may offer them a courtesy FYI review. This too-many-cooks system is as inefficient as it is illogical. A common example is a sales and marketing department that wants to review every ECO submitted, even when a proposed change is minute and product performance is not affected.
Another common problem occurs when parties responsible for implementing a change become part of the approval process as well (such as purchasing staff when buying a new part). But does a purchaser really have the technical know-how to alert an engineer that a change request is technically unsound? This is the type of frank question a company must ask when deciding who will approve ECOs.
In many companies, it is often desired, and sometimes required, that the technical or design team work with the execution (i.e., manufacturing) team when designing a product or change. However, such joint planning can cause delays and other unintended side effects. By asking the execution team to constantly review the design team's work, a company might unknowingly inhibit good ideas from forming, thus frustrating creative engineers. The charge of the design experts is to constantly improve products and processes; once an improvement is justified, it is the charge of the execution team to establish it. In other words, engineers order a change, and execution teams make it happen.
The flip side of this argument is that engineers might design something that is not workable or is much too expensive, in which case the purchasing department must review and approve an order up front.
What is important is to assess the benefits and drawbacks of each approach. If the purchasing department very rarely returns an approved ECO because it can't execute the order, then asking that department to intervene early on doesn't make sense. On the other hand, if engineers request products and parts that are very complex and difficult to find, requiring purchasing approval on some ECOs might be necessary.
Overall, companies must take a close look at who is approving their change orders and take the time to ask, "Why?" They should then try to shift some of the approval responsibility from management to knowledgeable and experienced employees in their individual departments.
A NEW, BETTER PROCESS
The Team Approach. As with most major improvement initiatives, assembling a diversified team to create a new ECO process is a good idea. It is imperative to include representatives from all departments that take part in the change-order process. Individuals who provided the most ideas or input during the initial interviewing process are good candidates for the team. QA must be adequately represented as well, to ensure all regulatory commitments are met. It is important to note that the QA department does not have to approve every ECO, although in many companies it does.
Categorization. Before starting, the ECO team should categorize the different types of ECOs it has, since the procedures for processing each will be different. The team should devise criteria based on safety concerns, regulatory requirements, and technical complexity. This is an important place to start, as many companies have too-broad categorizations of ECOs, or perhaps only one. The categorization of each ECO will dictate who will approve it.
Breaking It Down. To create a new ECO process, the team should ask, "What are the basic steps for getting a change order processed?" ECO processing can be viewed as three basic steps: creation, approval, and implementation.
The person desiring the change creates the change order and completes the initial paperwork, data justification, and validation (if necessary). Once this step is completed, knowledgeable experts from the necessary departments evaluate the ECO's technical and regulatory merits. When all of these departments agree that the change order makes sense and is compliant, then the order is executed, or implemented. Implementation consists of scrapping old material, purchasing new parts, distributing new procedures, and updating legacy systems.
Using the three-step process as a baseline, the team should methodically study each step to determine the simplest way—given the resources and technology available—to accomplish it. This approach is similar to the so-called "lean manufacturing" methodology, where one does only the minimum work necessary to produce the exact amount of high-quality output needed. Taking this approach with each category of ECO is wise, since requirements are different for each.
Using the lean approach, the team should eliminate unnecessary paperwork, unessential approvals, ECO-document errors, poor validations, and other wasteful phenomena. This is a challenge because it requires a real willingness to change existing practices and behavior. Change is even tougher in regulated industries because of the ever-present fear of FDA's looming hammer. In spite of these challenges, however, a focused, diligent approach can yield significant reductions in paperwork and an increase in efficiency.
Setting Time Limits. If a company wants to set cycle-time goals, it needs to hold people accountable to some hard numbers. After deciding on the new process, the ECO team will know with near certainty the required time for each process step. From there, the team can establish cycle-time goals for each step. This is a bit difficult for the approval and implementation steps, because approving or implementing ECOs is often just one of many responsibilities of those who perform these tasks.
To start, the team should evaluate the current ECO demand to determine the work required of the approvers and implementers. Using this estimation, the team will determine the required turnaround time. Leaving too much slack time should be avoided, as this just creates more inefficiencies and pending ECOs in the system. Time goals should be set as low as possible.
Two other important aspects of time-limit setting are escalation procedures and default approvals. Many companies will interpret an approver's absence of approval within the required time frame as a "default approval." Assuming default approval is dangerous in regulated industries, however; so another option might be to notify the appropriate supervisor about an approver's failure to meet his or her deadlines. Whatever the method used, the intent is to promote and enforce accountability and responsibility.
Going Electronic. An obvious approach to improving paperwork-intensive ECO processes is to convert them to electronic systems. This not only saves trees, but improves processing speed and quality as well. Making "smart" forms (i.e., those that function only when all required fields are complete) available on a network or the Web and routing them electronically to approvers and implementers are two of the basic steps companies can take.
A fully electronic ECO process also includes the use of electronic signatures, which poses an obstacle in regulated industries but yields a significant return on investment when implemented properly. As a transitory stage to electronic signatures, companies can have documents reviewed on-line and keep a hard-copy approval sheet in a central location for approvers to sign after their reviews are completed.
While going totally electronic can cause a giant leap in productivity, it's just as important to remember that the basic business processes behind the automation need to make sense and be efficient. So the analysis and work required for any hard-copy ECO still needs to be done. Otherwise, companies run the risk of automating an inefficient, defective process.
Getting It Done. From an implementation standpoint, there are various departments involved—purchasing, production control, warehouse, operations, and others—that have to make sure the proposed change happens on time and without material or process discrepancies. By this time, the ECO creation and approval steps are complete, so the parties involved in those aspects are not needed.
One way to expedite ECO implementation is to have an "implementation owner" be responsible for seeing the implementation through. Usually this person should be a member of the production-control staff, since he or she will be the one controlling and planning the production activities on the manufacturing floor.
Other recommendations include electronic distribution of new procedures, and writing up and adhering to a simple implementation checklist to ensure that all the proper implementation steps have been completed.
For updating legacy systems such as SAP software, installing programs in which information entered on a spreadsheet can be automatically downloaded into the legacy system increases efficiency and accuracy. Since the legacy system will require input from various parties, a company can choose to have individuals enter their relevant information into an on-line smart form, after which a person fully trained on the legacy system's operations can take the forms and enter the data directly into the system. This helps avoid providing data-entry access to too many people.
SEEING POSITIVE RESULTS
Rolling out a new process is always tricky, especially one involving something as ubiquitous in the manufacturing environment as ECOs. It is usually best to use a pilot program, which only a handful of people are trained and begin to use the new ECO process. Their experiences will provide a real-world test and permit feedback from actual users. Companies should plan on at least two to three months for a pilot program. Any attempts to speed up this process will likely result in failure, and all of the great ideas generated will go to waste.
As with any new primary process, iterations might be necessary, and the ECO team might need to tweak and improve the original design. This is fine, unless the changes are drastic and sweeping. Significant changes to a newly implemented process might alert a company that it didn't do enough homework or analysis up front and may have to go back to the drawing board.
With most ECO process changes, it is not uncommon for companies to see significant reductions in cycle times and paperwork and increases in quality. Change-order process improvements beyond those outlined here do exist; companies might want to research other methods better suited to their own operations. Regardless of which particular methods a company chooses, however, with focus and effort the common complaint of, "By the time I see my ECO implemented, my change is obsolete!" will be a thing of the past.
Gregory Lanides is a manager at Tefen USA (Foster City, CA). Karen Watson is former QA director at Becton Dickinson (Franklin Lakes, NJ).
Copyright ©2001 Medical Device & Diagnostic Industry