REGULATORY COMPLIANCE

Do you need to know whether a regulation applies to your product? Are you looking for representation in discussions with a regulatory agency? Do you need to know whether a particular defect is a “safety” defect? Are you concerned about the potential of a regulatory non-compliance? Is it unclear whether a regulation applies to your product? Have you analyzed the regulation, but it doesn’t seem to make sense? Does your product comply with the regulation, except for one inconsequential point? Are you unsure how to measure or document compliance?

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

DESIGN & BUILD FOR SAFETY

Most manufacturers do their best to design and build products that are reasonably safe when used as intended. Similarly, most manufacturers do their best to develop products that comply with applicable regulations.

Doing the right thing, however, is not the same as being able to demonstrate or prove that you are doing the right thing. Whether in connection with product liability litigation, in response to a product safety investigation or recall, or public relations crisis, many companies struggle when called upon to document the product safety-related steps that they took and why.

PROCESS MAKES PERFECT

Most companies have processes such as requirements engineering, D-FMEA, etc., that act to preclude hazardous and non-compliant products. Just because you had and followed effective processes, however, does not mean you can readily prove that you had and followed these processes, or that they were effective. Some processes, for instance, are not documented. Or are inconsistently documented. Or aren’t routinely audited in a way that allows the manufacturer to prove that the processes being followed are effective.

Are your compliance processes documented in inconsistent formats? Do different silos and regions use inconsistent processes for the same work? Could you look at a map of your processes and readily identify inefficiencies or gaps?

GET ON THE SAME PAGE

There are many reasons to invest in a clear, integrated framework of process descriptions in a common format. For instance, just like speaking a common language makes it easier to do business, it makes sense for different silos within an enterprise to share a common process language.

Of course, each silo is sure to have processes unique to its challenges and business practices. Using a common set of grammatical rules, syntax, symbols, naming conventions, etc., means that when key personal take on new roles, their learning curve can be considerably shorter. Using common syntax and grammar in process description also means that it is easier for executives to get a quick handle on even the detailed aspects of an issue when a problem is escalated.

Harmonized process descriptions are also very useful in facilitating audits. Auditors can move through records quickly when they understand the roadmap. Harmonized processes are highly useful in problem-solving. Just as with DevOps software debugging, being able to quickly reference the standard flow of information, people, products, things, services, and decisions, makes the discovery of deviations faster and more accurate.

Ask about how we can help you do what you do, better, cheaper, faster, and safer.

LET GO OF MY LOGO

If you’re concerned about how to deal with a potential violation of EPA regulations, you’re not alone. One of our clients manufactured a water heater that had been 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.

WHAT IS NON-COMPLIANCE, EXACTLY?

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.

A PENNY SAVED IS A PENNY EARNED

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.

WHO’S RESPONSIBLE HERE, ANYWAY?

Are your products or components made overseas? Does that impact our regulatory compliance? If you assemble products from components purchased overseas, who is responsible for compliance reporting? Are your products all made-to-order? What if your products are hand-crafted? What if you don’t have documented processes? What if you’ve tried, but your products can’t be shoehorned into an off-the-shelf compliance approach?

Need an engineer who can read between the regulatory lines? Looking for an attorney who knows how to work with engineers? Seeking a balance of legal expertise with a thorough understanding of product development? Want the resources, experience, and expertise to “bridge gaps” among the stakeholders? What if your product compliance advisor is “fluent in cross-functional collaboration” and can help you reach better solutions, faster?

Reach out about a legal or engineering secondment.

GETTING TO THE ROOT CAUSE

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.

PREMIUMS GONE WILD

If you’re facing increased liability insurance premiums due to a product safety recall and related liability claims, you’re not alone, and we can help. 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.

RIGHT-SIZED RECALL SCOPE

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.

GIVE US A CALL

We’re your flexible and scalable product safety team. We’re on your team, but not your payroll. Contact us via the email contact form above, or by telephone at +1 (415) 324-8818, for a confidential, risk-free evaluation or about any of our product safety-related services.

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