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Any regularly repeated activity that involves more than a few steps and more than one person is a candidate for process documentation or process mapping. When multiple employees are all doing the same repeated activity, everything else being equal, most of the time one of the employees will be faster and more accurate than the others. While some differences are no doubt accounted for by individual differences in skill, in most cases some of the efficiency differentials are due to process. Whether intentionally or by happenstance, one employee is following a more effective series of steps (process) than the other employees. It follows that documenting, and having the rest of the employees adopt, the most efficient process will generate a net improvement in overall efficiency.

Drop us a line for a complimentary evaluation of your regulatory risk profile.

The larger the organization, the greater the number of employees, the greater the number of processes, the greater the number of repetitions of those processes, the more there is to gain by determining which is the best process and adopting that process throughout the organization. Not every form of work is amenable to process mapping or improvement. Some activities are almost entirely “bespoke” and pointless to document. “Creative” work, such as painting, poetry, music composition, come to mind. Process documentation is nothing more than writing done the steps of the process. The amount of detail can vary, but critical to the creation of useful process diagrams is a common syntax, grammar, and vocabulary. Also critical to effective process diagramming is the participation of the people who actually execute the process on a daily basis, regardless of where these people fit in the organizational hierarchy. Effectively documenting processes requires knowledge of the process documentation grammar, syntax, and vocabulary.

It also requires the ability to ask opened questions and listen carefully to the answers. It is necessary to know how and when to follow up, seeking further detail or confirmation. It also is important for the process documentation facilitator to be patient and resist the impulse to make “obvious” improvements to the process during the documentation stage. But this tendency must be avoided. It is critical to capture the process as it is actually practiced. Or at least as the stakeholders believe that it is practiced. Only by using a common format to first document processes in their “as is” states can we begin the task of improving the processes. Think of planning a road trip using a map. It is more difficult if the maps are not in the same format (e.g., North up, scale, contour, key, language, etc.).

Have you already hired the best subject matter expertise that money can buy, but they’ve been kneading the problem for 2-years with no end in sight. First, the corrosion guru from Philadelphia convinced nearly everyone that the problem was regional and seasonal. That led to a service bulletin targeted at a subset of the market. Unfortunately, the corrosion guru was mistaken. Next, the Notre Dame coatings whiz persuasively identified root cause as deviations in No. 3 spray painter maintenance schedule. After a second service bulletin, that hypothesis turned out to be a bust, too. Maybe they were both right, and both wrong. What if the real answer is more nuanced, with multiple contributing root causes? Sometimes you need a structured problem-solving facilitator to solve the root cause. Someone who does not purport to have any subject matter expertise relative to the problem. Someone with no skin in the game. What if your product compliance advisor was a truly disinterested facilitator? A structured problem-solving process expert, not a subject matter expert. An advisor fluent in 8D, 5-Whys, Kepner-Tregoe, Ishikawa or Fishbone. Someone to herd the cats.

Let us know how we can help untangle your knots.

Regulators sometimes push for the scope of the recall to be significantly more expansive than you know to be necessary. What if you need to “bookend” the beginning and end dates of the production lots that could potentially include defective product? What if, to do this, you have to break down the environmental and human factors? What if you also need to isolate metallurgical and other material considerations? What if your product safety advisors “understood your products and development process,” possessed a “solid knowledge of common high-risk failure modes” and could design a repeatable test confirming your hypothesis? What if you need to the test results and findings of your analysis documented and preserved on video? What if you need a witness capable of testifying about the test protocols and results? What if you need everything consolidated into a persuasive slide deck suitable for presentation to the regulators and customers?

Drop us a note to find out how we can help you, present, persuade and prevail.

Flexible, scalable, product safety team. On your team, but not your payroll. Contact us for a confidential, risk-free evaluation or about any of the following services: Design failure mode effects analysis | Fine tuning tone-at-the-top | Focus group analysis of social media | Insurance renewal support | Issue escalation process | Lessons learned processes | M&A “due diligence” and acquired entity integration | Notice of proposed rulemaking | Process development, documentation, implementation and audit | Product crisis management | Product safety compliance plans | Record retention and litigation hold | Regulatory agency interface | Regulatory interpretation | Regulatory subpoena analysis and response | Regulatory waiver requests | Requirements engineering (regulatory requirements, customer requirements & “due care” requirements) | Sarbanes-Oxley reporting | Service bulletins & recall design | Structured problem-solving facilitation using | 8D, Kepner-Tregoe, Fishbone, 5 Whys | Supplier vetting | Test design.

Let us know how much or little help you need to stay on top of your regulatory compliance risk profile.

Facing increased liability insurance premiums due to a product safety recall and related liability claims, we helped a manufacturer negotiate more favorable rates by developing and documenting a cohesive risk management strategy. This included recall countermeasures, responsive process improvements, claim data analysis, and a strong liability management strategy for recall-related litigation. We also helped the manufacturer present their strategy at the insurance renewal meeting. The manufacturer was able to persuade their insurers that their risk management strategy would effectively contain claim costs. This resulted in a renegotiation of the premium increase.

If you’re paying higher premiums than you used to, drop us a line for a complimentary evaluation of whether we may be able to assist.

A particular model of water heater had previously been Energy Star certified. Since the time of the initial certification, the criteria for carrying the Energy Star logo had changed. That particular model of water heater, however, had not been redesigned to make it satisfy the new Energy Star criteria and therefore the water heater was no longer qualified to carry the Energy Star logo. In a regulatory compliance oversight, the manufacturer did not revise the on-product labels. Before the problem was noticed, in a periodic quality audit, the manufacturer shipped 175,000 water heaters that incorporated the Energy Star logo in violation of Energy Star requirements. The on-product label did include accurate, verifiable and certified efficiency and performance data for the model in question. The question was whether the unwarranted use of the Energy Star logo constituted a regulatory non-compliance and if so, what were the consequences? Analysis of the subject product’s use profile confirmed that the incorrect label did not constitute any kind of product safety hazard. Analysis of the marketing, distribution, sales materials for the product confirmed that the only place the Energy Star logo was shown was the on-product label. All of the other places where the product performance specifications were noted, the numbers were accurate and the Energy Star logo was not included. This included the manufacturer’s website, marketing brochures, the owner’s manual and so on. Moreover, the product was always sold in a carton. Accordingly, it was extraordinarily unlikely that consumers would have relied on the mistaken information in the on-product label before deciding to buy the product. Therefore, since it was highly improbable that a consumer would have purchased the product because it bore the Energy Star logo. Given those facts, the regulator agreed to “silent” service bulletin approach to the issue. Anytime a dealer ordered parts for that particular water heater, along with the parts the manufacturer shipped a correct label (sans Energy Star) and instructions for application of the on-product label. This compromise approach saved the manufacturer $4-5 million in recall costs.