That is how I started my introduction as the new vice president of quality assurance to the executive staff for the division of a multi-billion dollar medical device manufacturer. I was following a typically incredible presentation given by our vice president of marketing and I needed to 1) Introduce myself as a member of their team, and 2) Provide an understanding of what quality (whether it’s in a regulated industry or not) should and can do to serve the business, all while keeping them as engaged as the entertaining speaker before me was able to do.
Fortunately, the previous presenter had left an easel with a big dollar sign set squarely on the paper facing the audience. It sparked an idea in me and I asked for permission to use his artwork—a request that was immediately granted. As the group wondered who I was and what I was doing, I began drawing a cake around the dollar sign. I then drew a car with occupants on a road with a bunch of potholes and a policeman—all leading up to the cake.
This is where my story began.
“Do you like cake? I sure do, and do you know what I also like? I like money! So, for the sake of my story let’s pretend this cake that I’ve drawn represents corporate earnings and let’s pretend the car represents the company and we are all inside. For me to get my cake, the company car must run well to get to its destination.
My role in this company is to ensure quality/quality compliance. It is a function that is a service to the business, so let me put a big ‘Q’ on a person sitting in the back seat of this car here. I am in the back seat so you may hear me yelling from time to time to ensure I am heard by those in the front seats. In addition, it may not be pleasant, but please remember I’m just trying to help the company avoid potholes that will either delay us or prevent us from getting to the cake. Remember, I like cake!
Also, since we are in a regulated industry, I may also tell you that we need to take a detour or stop for some documented maintenance from time to time because I know there is a police roadblock up ahead. It may make you unhappy because it will delay us from getting to the cake, but trust me, in the long run, its best to avoid upsetting the police (the FDA and other Competent Authorities in our case). They can stop you altogether, and no one will get cake!
Bottom line folks—quality people are like everyone else; they like cake.”
This is a true story with a clear message. The role of the quality function is to support the business. While at times, it may require a stop or delay activity in the interest of compliance, its core motivation should always be to serve.
It is extremely surprising to see how many quality professionals across many different organizations who are blind to the opportunities in front of them in which they could partner with their business team members for the good of the company.
Too often, they confine themselves to a role of quality control “police” or they hamstring themselves and the organization via precedent interpretations of regulatory guidelines, thus preventing creative options.
(Note: The message of this article is NOT meant to risk safety or circumvent any regulations, nor does it advocate avoiding the intent of any regulatory guidelines or standards; patient safety is and will always be job number one.)
There are, however, many opportunities for quality professionals who understand the regulations, guidelines, and applied statistics to help identify opportunities for improvement within their organizations—all without incurring any additional quality, safety, or compliance risks. All it takes is a different mindset, and then, we can all get cake.
Following are a few examples of the different mindset required.
Case #1: Streamlined Release Process ($14 million in cash-inventory reduction)
Indeed, the big project example is upfront, but it does represent the type of return quality professionals can provide to their respective businesses if they open their minds to the fact that quality is not just a matter of compliance. Instead, they need to realize quality represents the improvement of every process that takes place within the company.
In this first case example, the quality manager of a medical device company was essentially unhappy that 14 days of inventory needed to sit and wait to be released. She pulled a group of impact individuals together and developed a value stream map of this process. They identified and mitigated several different bottlenecks and defect producing steps within the process. In addition, they streamlined the batch record contents and eliminated certain elements found in their release documentation. Further, the quality manager and her team implemented a heat aeration step.
All of these activities drove the release cycle time from 14 days down to seven days, eliminating seven days of inventory and providing the company with $14 million in cash.
Case #2: Incoming Inspection ($375,000/year in savings—WIP inventory reduced by $600,000)
At an electro-mechanical medical device assembly plant, the internal audit team identified issues regarding the overflowing storage of quarantine material in the warehouse. The quality manager of the site immediately set out to mitigate the potential compliance risk. A funny thing happened, however, on the way to the play. This quality manager identified several opportunities related to the receiving operation that were causing much of the quarantined overflow. By applying proper statistical tools and implementing a compliant, risk-based, dock-to-stock strategy plan, the plant was actually able to reduce QA overhead by 3 FTEs (full-time equivalent) in the incoming inspection department, while at the same time, reducing destructive testing and reducing a large portion of WIP (work in progress). In addition, all of these benefits were realized while addressing the original potential compliance risk.
Case #3: Microbiology Lab ($210,000/year in savings)
A medical device manufacturer had a long-standing, seven-year contract/relationship with an outside lab that was responsible for handling microbial sampling needs for the site. A quality engineer who was involved in performing an internal audit of the QA labs just happened to come across an invoice to the lab in question. With a “service to the business” mindset, she took it upon herself (as a business partner) to assess the opportunity and determine the requirements of bringing the required sampling in house. The firm established the necessary facilities within its own company and maintained necessary compliance. The entire effort ultimately saved the company $210,000/year.
Case #4: Supplier Quality ($75,000/year in savings)
A supplier quality engineer was preparing slides for an upcoming management review as he had done each quarter for the previous two years. He gathered his metrics and provided charts that illustrated the typical supplier quality key indicators, measuring delivery, quality, responsiveness, etc.
For some reason, however, the process was different this time. He took a more discerning look at the data and realized that, although his highest volume component suppliers were performing consistently (i.e., no adverse trends), they were creating a significant amount of logistical work for the part of his company handling various issues in delivery and quality. They were consistent, but their performance was also regularly costing the company money.
Rather than continuing the practice of issuing and managing supplier corrective actions (SCARs) to “address” the issues, he proposed an idea to his manager. He requested approval to attend a Six Sigma Green Belt training seminar; he wanted his project to focus on the improvement of their highest volume supplier performance. His project reduced supplier-related non-conformances by 45 percent and eliminated redundant sampling of components by validating the measurement system at the supplier’s facility and accepting their product as is—dock-to-stock. The total labor and destructive sampling testing saved $75,000/year.
Case 5: Risk Management Procedures ($1.6 million/year in savings; plus $10 million in potential sales)
While working for a combination device manufacturer, a quality professional was tasked with reviewing the current company risk management procedure to ensure its alignment with the most recent ISO 14971 requirements. In her research, she identified inconsistencies between the risk management documentation and the statistical sampling procedures. Further, she noticed the sampling procedures directed a level of sampling that was significantly higher than what should ordinarily be required or expected for specific risk profiles. She made the necessary procedural design changes and processed the new procedures through the proper channels. Her job was complete, right? Unlikely.
This quality individual was constantly seeking opportunities through which she could support the business beyond her compliance activities. She was aware of a very large list of ongoing validation activities that supported a new manufacturing site. Protocols for the validations were all written and approved with the old sampling requirements. She sought out the protocol owners and trained them on the new procedures. The result of her new “Linked with Risk Management” procedures was a reduction in sampling, resulting in a savings of $1.6 million in samples and labor. In addition, time savings reduced the site acceptance by more than a month, resulting in an extra $10 million in potential sales.
Case #6: Complaint Handling ($75,000/year in savings)
A quality engineer for a medical device company that made Class I and Class II disposable medical devices was working in the post-market surveillance department handling complaints. Over a number of months, he found himself receiving, handling, investigating, and documenting the same type of complaints for several product lines numerous times.
While reviewing the FDA’s Quality System Regulation, he came upon the following:
PART 820—QUALITY SYSTEM REGULATION
Subpart M—Records Sec. 820.198 Complaint files.
(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.
(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.
He immediately brought this to the attention of his manager with a proposal to potentially reduce the department’s workload. Fortunately, the manager was open-minded and willing to listen, but made it clear to the engineer that complaints, as well as their investigations, are an extremely critical part of a compliant quality management system.
Nevertheless, they pursued this opportunity, and after a clear evaluation and thorough risk analysis performed by a number of stakeholders within the organization, the quality team was able to implement a system that maintained the proper level of due diligence and compliance while reducing the unnecessary amount of complaint investigations performed by the team. One full-time position was eliminated from the post-market surveillance group through attrition.
Benefits from Quality Outside the Company Walls
Each of the previous examples demonstrates how quality individuals can make an immediate internal impact on their business returns.
The benefits spearheaded by “quality assurance or individuals that provide quality support,” however, can also extend beyond the walls of the organization to make a larger impact across the industry. Currently, I am part of a very well organized and supported consortium made up of engineering, business, and quality subject-matter experts from several Fortune 500 companies within the medical device and pharmaceutical industries. All of us have the goal of realizing the benefits from decades of technical advances, particularly in the area of injection molding. (See “Part Process Development and Validations for Multiple Machines” in the July/August 2017 issue of MPO; http://bit.ly/mpo190499).
We are at a much different place than we were 15 to 20 years ago when the first and current documents were published providing Process Validation Guidelines for Medical Devices [GHTF/SG3/N99-10:2004 (Edition 2)]. While the information in those guidelines still provides very adequate direction to support product quality, we now see an opportunity to evaluate and change the way in which we meet those guidelines given progress in other areas of our business.
Phase I of the aforementioned consortium looked at, and identified, opportunities to streamline and/or eliminate the need for certain revalidation activities, while Phase II of the consortium recently kicked off to examine utilizing the advanced level of information and controls available to take advantage of other opportunities. Stay tuned for the results of Phase II.
For now, let’s get back to the cake.
Within this article, several real-world examples were provided in which quality professionals were able to identify and implement significant business improvements that were discovered during their day-to-day activities. It can happen. All that is needed is a change in mindset and expectations, particularly for those individuals working within regulated industries. The quality professional’s number one priority should always be to ensure patient safety and regulatory compliance; however, they should not neglect or fail to understand their responsibility in supporting business performance outside of compliance.
The two deliverables are not mutually exclusive. So, go out there, avoid the potholes, and sidestep the police, but don’t stop there. Get that car and its occupants to the cake.
Paul Robinson is an accomplished quality executive with over 25 years of domestic and international experience. His career has been built on a solid foundation in quality, engineering, and manufacturing through progressive positions focused on quality systems, design assurance, and operational excellence with companies such as Covidien, Boston Scientific Corp., and BARD. Robinson is a recognized QA/RA leader, having maintained over 20 manufacturing plants worldwide that produced various products including plastics, electronics, pharmaceuticals, biologics, and woven/non-woven materials. As an operational excellence head, he conceived and launched an organization-wide effort that realized over $260 million in three years. Currently, Robinson is the vice president of operations for Quality Systems Consulting Services (QSCS). QSCS offers the unique value proposition of delivering regulatory compliance essentially free by integrating operational excellence principles.