Let’s begin this topic by defining our terms. When we say “mirage,” an image gets conjured, that of a shimmering pool of cool, life-saving water in the middle of a desert that is being jackhammered by a searing mid-day sun. This image, we now know, is created by atmospheric conditions. The word has come to mean “something that appears real or possible, but is not, in fact, so.” In others words, it is fantasy, a figment of one’s imagination. In the hard-edged world of business and manufacturing, we say that we are seeing what we want to see, not what is there.
From the Mirage of Supply “Chain” Quality to the Reality of “Cirque du Soleil” Supply Networks
“Chain” usually conjures the image of a strong, flexible, metal object. This is a metaphor only, and this mirage can easily create a gap in management with serious consequences.
Far from having real the kind of substance and constancy that metal implies, manufacturing across a supply chain calls to mind metaphors closer to an intricate multi-ring, multi-tier performance by the brilliant Cirque du Soleil.
Imagine the trapeze artists, for example, needing to rely on others’ performance to catch them in another ring, and one tier down or up, without actually being able to see them.
In other words, the metaphor of a chain, something solid and reliable, can create such a gap in perceptions that a company can easily fall into the predictability and comfort of the status quo. The swirls of variables with which your QA professionals are dealing confront them with questions such as:
1. What is the RANGE of products involved overall (including your suppliers, as well as the suppliers of your suppliers and their suppliers?
- How varied are the raw materials?
- What is the range in the variety of ingredients, components, and subcomponents?
- What range of software is required?
- Range of laboratories
- Range of kinds of other processes such as sterilizers, etc.
- Range of services required along the entire external and internal production process
2. What level of COMPLEXITY is involved in the supplied products?
- How complex are the raw materials?
- How complex are the ingredients, components, and subcomponents?
- Level of complexity of the software required
- How sophisticated do any laboratories need to be?
3. What kinds of RISKS are associated with each of the items above?
- What level of risk is associated with each category or item listed above?
- To what extent does the level of risk change depending on how your product or service is used?
The above really does reflect the reality of a three-ring, multi-tier Cirque du Soleil performance much more than the stable image conjured by the term “Chain” in “Supply Chain.” (This variables listing is based on a description of a ruling by the FDA* cited further below.)
The Material Variability Challenges of Fluidity
The layer that we see, the manufacturing organization itself, may appear stable, a study end-point to the chain made up of solid links. The reality is that, behind it, there is a constantly-moving assortment of material variability challenges. These include not only the actual materials but also the performance of the ingredients, parts, and sub-assemblies that move every day between shipping and receiving locations. Some of these are destined to be quarantined or rejected, setting off separate processes of nonconformance resolution and refunds.
Some chains are organized hastily (at any level – either by your First Tier supplier or somewhere at the levels of the suppliers to the suppliers). The chain may have been put together opportunistically, based on taking advantage of market success of a product, and it may disintegrate just as quickly. Others last through generations of owners. The fluidity or the stability of the chain may be affected by any one of your suppliers, whether they are visible to you or deeper than your First Tier.
Behind the Mirage in a Specific Industry
The result of this mismatch between the reality and the mirage is exemplified by the medical devices industry, as described in these excerpts from an article on the website “Medical Devices Summit” (see link at end of article). *
The U.S. Food and Drug Administration (FDA) recently issued a proposed order that will require manufacturers of automated external defibrillators (AEDs) to submit pre-market approval (PMA) applications. The order is a direct result of recalls and manufacturing problems tied to Supplier and Purchasing Control Issues… Research shows that the most common issues identified by the Agency involve the inadequate control of components purchased from other suppliers as well as design and manufacturing controls.
FDA received approximately 45,000 adverse event reports associated with the failure of these devices between 2005 and 2012. … Problems with the manufacturing of a capacitor from a supplier used in various locations of the AED led to a potential for the device to delay or not deliver defibrillating shock which might have resulted in a failure to resuscitate the patient.
According to FDA, the most commonly identified deficiencies for Purchasing Controls are:
- Inappropriate evaluation of suppliers.
- Changes to the components without notification to the manufacturer.
- Problems with the manufacturing of a component/subassembly.
- Inadequate incoming acceptance activities to detect nonconformities
- Inadequate or lack of process validation activities at the supplier.
Addressing the Range, Complexity, and Risks in a Supply Chain
The problems addressed above that can result in the death of a human being are not unique to the medical devices industry.
The question that every CEO addresses is “how can we balance quality with our mandate to earn a profit for our investors or owners?”
An Affordable and Effective Approach
The challenge is to find an approach that is both affordable and effective. A comprehensive approach to supplier and supply chain quality management calls for software-as-a-service (SaaS) solutions. The service makes geographic distance irrelevant: suppliers, co-manufacturers, and feeder plants in both nearby and remote locations, as well as in-house production departments, are accessible through secure supply chain quality portals, with equal power to prevent the kinds of breakdowns that can stop a production line or threaten an enterprise’s financial well-being and its brand image.
If your company has a supply chain, and if the material variability of the inputs to the supply chain impacts the quality of your finished product, and if you have a commitment to quality, then your company would benefit from implementing GSQA®. Some questions to consider include:
- Are the far reaches of your supply chain (supplier’s suppliers) for all practical purposes invisible?
- Are there inputs to your supply chain that make it essential to reduce material variability?
- Are there different methods of producing COAs (Certificates of Analysis) being practiced in your supply chain? Do your customers receive different COA formats from different enterprise locations?
- Does your company have a web-based method for tracking supplier non-conformances?
- Do you need to streamline compliance document scheduling, alerting, submittal and approval?
- Do you track yield improvement (compare the ideal product with the actual product and its ingredients, components, and sub-assemblies) on a regular basis?
If you answered “yes” to these questions, then GSQA could most likely help your company deal with the true complexity and the reality that exists behind the mirage of the “supply chain” metaphor.
Below is a graphic depicting GSQA’s ability to address the challenges faced in the Medical Devices industry. GSQA can be a good fit for your industry as well.