How to Develop a Defect Free Process


By: Jason Hogeboom

Jason Hogeboom, a proven Operational Excellence Consultant, has joined us to explain the procedure of developing a Defect Free Process. With an array of experience in conducting this procedure, Jason shares the ins and outs as well as challenges that are likely to be encountered. Read Jason's article to find out more.

What is DDFP?

"A DDFP (Develop Defect Free Processes) is a specialized type of lean Kaizen. It differs from a typical Kaizen because it has a particular predefined flow of steps. It's not a widely know procedure but if used systematically through your processes it can yield significant results. This procedure is typically used when seeing a high amount of error rates or quality issues around a process. Using this methodology often results in more consistency within processes as well as greatly reduced errors and an increase in quality.

A DDFP can come about in different ways, usually where a high number of deviations, mistakes and/or rejections occur in a process. This can be any type of process. I have performed DDFPs for sample submissions but also in running equipment or even reducing product rejection rates in Japan. In a previous role, an individual had to be separately certified in DDFP after obtaining a Green Belt to be able to run one. I was one of two certified to run a DDFP at our ~300 employee location where both biotech and device manufacturing occurred so I ended up leading a dozen of these."

Keep it Focused

"An important factor about DDFP is that you want to focus on a small portion of the process at a time, meaning you are focusing on a process or part of a process that takes a few minutes to a couple of hours depending on how many steps there are and how complex they are. The more steps and the higher the complexity, the shorter the window of the process you want to focus on. Several DDFPs may be performed on a process with many issues, but if there are a significant amount of issues within a singular process, you may need to completely overhaul it through a traditional Kaizen.

There are several reasons for keeping it focused to just a small portion of the process. Employees are taken away from their regular duties for two or three days to focus on each DDFP event. Focus can be lost, details can be overlooked and portions brushed over by examining too much in a single event - though, every single step should be examined and questioned."

Starting a DDFP

"A process that needs attention is identified and a charter is written and approved by the executive team. The charter consists of information including scope, team members, projected cost savings and timelines. The actual even is usual two or three days long. On day one, an overview training takes place explaining what DDFP is being performed. This is a form of lean training with a heavy emphasis on mistake proofing, removing waste and visual aids.

The team members are key in this procedure. It is important to have at least one, if not several subject matter experts (SME). These are the front line employees that are responsible for the daily running of the process. Depending on the complexity of the process, other team members may include an individual from Engineering, Process Development, Validation and/or Quality. Personally, I also highly recommend having an outspoken person who doesn't know the process at all. This is the person who can often point out things the rest of the team might glaze over. In my experience, most team members enjoy the process because they are able to be actively engaged throughout."

Map the Process

"Next, the part of the specific part of the process that is to be focused on is observed. If the process is done by different people and/or on different shifts, it is a good idea to video tape the process from the different operators perspectives as this can really help to illuminate inconsistencies. The video will act as a visual aid later in the process. Before going to observe this process, tasks should be given to various team members, there are many items to cover when observing and this should be shared out among the team. Spaghetti diagram, safety concerns, photos, video taping and Muda (the 8 wastes) should be performed and/or recorded during this time.

Then, map out the process and great a list of steps. This sounds easier than it is because this is where different operators might have different methods for doing the same thing. I have witnessed many times how operators can interpret standard operating procedures (SOP) in different ways when the SOP might be a little vague. This is the time to discuss it with different team members on which way is the best way and get everyone to agree. Many times, one way isn't necessarily better than another but you want to choose one for the sake of consistency."

Identify Risks

"Now that all the steps are listed out, put each of those steps into a FMEA. Usually the 80/20% rule works well here; 80% of issues coming from 20% of causes). This means that after the risk priority numbers (RPN) are calculated, target the top 20% for mistake proofing. In addition, add in any quick wins from the other 80%. You should also attempt to mistake proof from most to least effective mistake proofing techniques in the following order; elimination, prevention, replacement, facilitation, detection and mitigation."

Update and Communicate the New Process

"At this point, you should update the SOP with the use of visual aids. This is where you really want to define the process step by step with the use of pictures, expected outcomes, and actions if the expected outcomes don't occur. This is where taking good photos and videos of the process can come in handing. If there isn't a good photo, a screen shot of the video can be used instead. Sometimes there may be a need to go back to the process floor and stage some photos. You can also 5S the process by having a list of items, a layout of those items mapped, and similar things that are required to have stage prior to starting the procedure.

Once the process is done, the deliverables can be communicated to the executive team. A leaner process with mistake proofing and good visual aids can be communicated out as well as lessons learned and any parking lot items. This should be communicated with the team that performs the process as re-training. Communicate with them why the process has changed - usually, I will let whoever on my team was the SME do this retraining while I standby to assist with questions and concerns."

Challenges

"The biggest challenges I have faced are usually with the executive team. They tend to want to tack too much over a few days. If you do too much, then it can be really difficult to really drill down into individual steps. Quality over quantity is very important. More than one event can be held for different proportions of a process.

Another challenge is that often a manager thinks they know what the actions should be before you even start. They want you to get to their conclusion, using the methodology so they have to support to execute what they already have in mind. They simply want to show the executive team that they did due diligence to get to their pre-prepared solution. Honestly, throughout the procedure I let the process take us where it takes us and then follow up with a conversation with the manager and explain that the evidence just didn't take us where he or she was suggesting. Solutions should be coming from or vetted by the front line employees that are on the DDFP team."


Jason Hogeboom has worked in Biotechnology Manufacturing for over 25 years. During his tenure, he was trained in Best Practices in Operational Excellence programs; he received a Lean Six Sigma Greenbelt and became a champion in leading the Lean approach across various functions. After completing an AACSB accredited MBA in 2017 and Lean Six Sigma Black Belt in 2018, Jason made Operational Excellence a primary focus as he saw that these Best Practices can truly transform both people and companies. Jason will be joining us at OPEX Week Summer to discuss this topic further, find out more here.




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