|As supplier activities become more complicated,
there's a new role for a supply chain liaison consultant
who can facilitate activities between the
manufacturer and the product developer.
In order to achieve success with your outsourced manufactured medical devices, there must be cohesiveness between the manufacturer (Supplier) and the product developer (Customer). I’ve exemplified this role as that of the supply chain liaison consultant, involved directly with the development of the manufacturing processes, while in step with the roll-out of the product design intent. This article will discuss the five steps required to accomplish all of this while defining the role of the consultant. The consultant provides the tools and leadership to maximize the value of the supplier in their partnership with the customer.
In my role as the consultant, several factors need to be considered when assessing a potential supplier for a particular component or assembly. First, what are the supplier's core competencies and what applicable deliverables do they provide? This is critical knowledge because it determines the level of expertise and helps consolidate the supply chain. Historically, blanket considerations such as price & delivery trumped everything else when it came to supplier selection. While these certainly are factors, it’s every bit as important to consider their performance track record, primary processes, and what, if any, secondary processes are captured within their facility. When it comes to the selection process, it’s also important to confirm that there are resources available for a new project initiative team. This team represents the cross-departmental interests on the part of the supplier once the process development kicks off.
At this stage, all existing standard operating procedures (SOPs), work instructions (WIs) and data collection forms are identified, as applicable, for the process being defined. Also, all equipment that comes into play will be introduced with its associated Installation Qualifications (IQs) and Preventative Maintenance (PM) documentation. I align the two project teams at both the supplier and customer job sites for the first time to ensure all these prerequisite action items are met. Next, in my role as consultant I initiate the Process Operational Protocols (POQs) where applicable. This will become a collaborative effort on the part of both teams, with the protocols and reports signed off before the next phase of manufacturing deliverables is initiated.
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This next step is most critical in establishing what we’re quantifying in determining the supplier’s ability to manufacture product from a quality and cost perspective that benefits both sides in the relationship. In assessing what critical features to measure within the process, you factor in not the most critical feature to the design integrity but rather which ones are most critical to the stability of the process. In other words, while measurable features with very little allowable tolerance are certainly considered, they’re not necessarily that difficult to maintain during manufacturing.
This is where my role as consultant is most influential. I act as the neutral party while working with the supplier and the customer in reaching a compromise on what’s reasonable within the design intent. It’s been my experience that this is a most critical stage in the project and one where you often need a “broker” to ultimately reach a collaborative agreement.
When the process feature parameters are determined, a sample size for each deliverable is set. The desired statistical reliability and confidence are established now, as well. With this information in mind, the next step is to introduce the applicable Process Performance Protocols (PPQs). The consultant assumes the key leadership role while collaboratively working with both the supplier and the customer in drafting these documents for approval. Establishing the methods of measurement for all feature parameters completes this third step.
When the PPQs are completed, the data are captured and analyzed prior to report writing. Once the data are evaluated with a mutually approved method, the statistical targets are then deemed met with each process parameter or feature. Each feature is reviewed on a case by case basis and will determine, based on the statistical capability, the sampling rate from which each feature is to be measured moving forward. This is where you’ll likely see some deviations on the PPQ report, and that’s acceptable, as long as the features that missed the target of statistical reliability are measured with more frequency.
Once the collective team has completed this step, a major milestone has been accomplished. One can ascertain that the supplier selection, qualifying of the equipment and process validations have led us to the manufacturing of the components in a production-ready environment. We can now conclusively say, with a scheduled Gage R&R scheduled correlation between supplier and customer to support us, that the reports are now ready for approval in completing this step.
Our last phase in the process development is one that leads us to cost saving activities. Now that the validations have been completed, process costs can be quantifiably measured, which will in turn be evaluated against the profit margin. Armed with this information, in my role as consultant, I’ll align the customer executive team’s cost savings objectives in establishing a new project scope to outline the next set of deliverables. This will rely on determining scope based on targeted areas where there’s opportunity for cost savings.
We’ll include process improvements by way of enhanced technology, targeted high frequency inspection points, and the potential for design improvements. Assistance in design revisions could come by the revising the device after use in surgical cases.
Finally, a sustaining team should extend to the floor, where the most intimate knowledge of the process exists with the operators. At this point two sustaining teams in representing the customer and supplier are formed. The goal is to lead ultimately to a supplier/customer relationship that is a partnership. This cohesiveness leads to minimal inspection requirements, and ultimately a supplier managed inventory or “Kanban” system in meeting the demand with diminished inventory on hand.
After working as a consultant liaison, I’ve often wondered how we’ve gone without this role for so long in our industry. The role does require an intimate knowledge of the supply chain, along with a manufacturing background that supports process development on a high level. With the proper commitment and skill set required of this individual, the odds for a successful, timely launch between the supplier and customer will go up dramatically. In the end, this is about relationship building, and the pride and satisfaction in meeting the bottom line!
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Stephen O'Neil has worked in several capacities---entrepreneur, manufacturing representative, manufacturing engineering---which have allowed him to combine all this experience into consulting in a multi-faceted position. Stephen has built business plans for engineering solutions that included marketing facilities in the U.K. and U.S., developed product prototypes and delivered new product based on an orthopedic customer's design intent. Most recently, he has represented MIS Spine new project teams in the role of a manufacturing engineer, where he led the manufacturing effort to bring about product launches, through both internal & external supply chain resources, in expediting new product to market in support of the thoracic lumbar, anterior cervical and posterior lumbar regions. He may be reached at https://www.linkedin.com/in/steveoneil.