A.W102.1 Arete logo name RGB(255,0,0) R TM SM Arete Consulting
A.W128.2 Flickr - Janet Lindenmuth - Law Library Looks - Code of Federal Regulations - Title 49

Parsing regulations, analyzing requirements.

Thinking far beyond the box.

             Photo Janet Lindenmuth

About

Overview

Arete Consulting (“Arete”) provides nonprofit educational information and summaries of product- and vehicle-related statutes, regulations, standards, specifications, and other requirements. Arete may also provide independent conformity assessment, to review engineering designs and products in accordance with the applicable requirements, and then render opinions; regarding:

  • Product and vehicle regulations, standards, specifications, design, development, and construction (where “vehicle” means any vehicle of whatever type or nature, including ground-based motor vehicle, aircraft, and/or watercraft);

  • Secondary cell and rechargeable battery regulations, standards, specifications, material science, design, development, and construction; and

  • Crisis management relating to manufacturing, quality, vehicle failure-modes, and recalls.

Arete is meticulous, creative, and respectful with requirements and product quality. With its unique position of knowledge and experience, Arete is confident, decisive, and can move very quickly. Arete can assist OEM overflow from in-house regulatory and engineering teams, and all professional analyses are approached objectively and supported with empirical data to be bulletproof.

Choose Arete

Arete uniquely offers “one stop shopping”. How should regulatory information be obtained? Using the U.S. motor vehicle industry as an example, this is a simple comparison of costs across alternatives:

  • Option 1: Build a regulatory team in-house. Recruiting experienced personnel away from big automakers is difficult, there is low turnover in the field, and once an employee is on-boarded and trained as a regulatory engineer, they typically stay a long time with the company or even the whole of their career. Hiring new would require several people working nonstop for more than a year to accumulate the necessary tribal information by doing original research from scratch, with ample support from law firms specializing in the automotive field at $750-$1,000+ per hour. This is how many startups have painfully accumulated regulatory knowledge.

    However, “legal counsel” is not the same as regulatory compliance leadership. Lawyers are not knowledgeable in engineering nor production, and engineers are not expert in the law nor regulations. Lawyers may have legal opinions, but lawyers don’t know how to technically apply them, because lawyers don’t actually know the hundreds of technical regulations that affect an engineer’s or policymaker’s work. Even if lawyers did memorize what the law requires for regulations and engineering standards, lawyers can’t share any engineering interpretation, because typically lawyers have zero credentials or experience in engineering or production.

  • Option 2: Choose Arete. The concept of Arete is sharing, by applying research to multiple situations. This will always come in faster and less expensive than Option 1. Arete contributes value by leveraging technical backgrounds to reveal what everybody is looking at but does not see. Arete’s perspective fully integrates all requirements of the market, manufacturing, engineering, and regulatory.

  • Option 3: Contract with a competitor. Arete is not aware of any competitors that integrate engineering, manufacturing, and regulatory consulting, which is why Arete was created.

Regardless where a product is in its lifecycle, regulatory is always needed as far upstream as possible. Regulatory compliance and ethical engineering start with identifying applicable requirements. Arete can encourage teams to optimize designs, development, and testing campaigns. Arete can also assist manufacturers to iron-out engineering and manufacturing problems on the line. And Arete can help companies to triage, troubleshoot, solve field failures, and guide manufacturers through the recall and mandatory reporting processes.

Even if Arete wasn’t involved early on, there is plenty of work remaining to do. For example, after a vehicle gets into actual retail production, all manufacturers will eventually have recalls, they cannot avoid that certainty. If a company wants to achieve its proposed business plan, then it must be compliant and support inevitable NHTSA recalls, an ever-growing list of federal regulations, and the necessary good process foundations. From solving manufacturing and quality issues, to vehicle failure-modes, to crisis management and recalls, Arete can help with all of that.

A company’s internal legal team and external counsel can only contribute to a point but will not be able to provide regulatory information integrated with engineering and manufacturing advice. Arete can help where others cannot.

A company’s internal compliance department can also only support to a point. Even if a startup’s small internal team has some experience, Arete should be involved. Arete can provide veteran experience across years of production, directing field investigations, managing RCA research, and reporting scores of safety and noncompliance recalls. Arete brings a perspective that a small in-house team cannot provide.

Produce ROI

If Arete provides information directly, ROI can be measured as savings between the best-case minimums, as opposed to the worst-case maximums of failure and recalls.

  • For example, 1x is the minimum to design and develop a product to requirements; only a very small fraction of this would be information cost. If not properly designed to requirements, 10x is the correction cost to fix the product before it enters the market. And if not caught and corrected before delivery, 100x is the cost to remedy inevitable field failures and recalls.

  • When a company is pre-production, working on a design, maybe even taking pre-orders, this is an advantageous time to consult with Arete, to help identify or even avoid regulatory concerns. The reliability of the 1-10-100 Rule and its prediction of 10x-100x cost savings as a project goes forward in time is reliably accurate.

  • For the manufacturer who consults Arete early in development, ROI as savings could be as low as 10x – 1x = 9x relative to what would have been spent on correction costs, or ROI could be as high as 100x – 1x = 99x relative to what would have been spent on failure and recall costs.
A.W136.1 The 1-10-100 Rule

Image Arete Consulting

The benefit to deploying Arete’s particular value now would be to help prevent accidents and incidents in future. It is always better optics, easier, quicker, and less expensive to do something right the first time. The results would be less headaches. Increased safety, quality, and regulatory compliance. Confident stakeholders, satisfied regulators, and happier customers. Fairness, transparency, and accountability. In short, movement toward a better world.

If a manufacturer has already contracted with a consultant, and if Arete provides assistance, ROI can be measured as efficiency, keeping the project on-budget and on-time, and supporting longevity of the manufacturer’s and contractor’s personnel.

  • For example, Arete can be tasked to rapidly bring inexperienced personnel “up to speed” on industry-specific compliance requirements, online resources, and best practices. When the contractor’s personnel later interact with the manufacturer about suppliers and production, this means they can communicate more effectively, focus the discussions, and spend less time on remedial topics. Arete can help significantly reduce project fatigue and frustration for everyone involved.

  • For the contractor, ROI as efficiency could increase 20% or more, such as a two-month project that is saved from being delayed two weeks, by precluding out-of-scope ad hoc requests and preventing uncertainty in making decisions due to unfamiliarity with product requirements.
Process

Arete’s typical preliminary communication includes:

Arete’s information of surveys, reviews, assessments, and opinions may include:

  • Survey a particular market and jurisdiction’s regulations and compliance testing requirements.

    • For example, provide a comprehensive list of applicable U.S. federal or state regulatory motor vehicle requirements.

    • Explain and interpret the requirements.

  • Plan and/or perform audits of existing:

    • Vehicle designs, drawings, systems, and prototypes.

    • Documentation system and any preparations for ISO registration.

    • Design and development process with iterative feedback loops among departments and business units, including current state of any use of D/PFMEA, DVP&R, PPAP, APQP, RCA/8D.

    • Regulatory team and legal team relevant to product compliance.

    • Operations and certain business processes relevant to product compliance.

  • Plan guidance during the iterative process of design, development, and testing.

    • For example, suggestions for design to comply with regulatory and/or other requirements.

    • For example, cell and battery research, experiments, surveillance of testing, suggestions for design, production, and process control.

  • Plan testing campaigns of current state of vehicle prototype for compliance, safety, functionality, quality, durability, and reliability.

Arete’s crisis management information includes analysis of data and sites for quality, manufacturing, or recall issues, project management of research and RCA, technical reports for solutions, suggestions for NHTSA reporting on service bulletins, safety defects, non-compliance, and recall remedies and execution.

Arete understands that time is money, so there will always be a fast turnaround. Schedule will be proportionate to project risk and SOW complexity. Progress, delays and challenges are updated immediately and honestly.

The Project Management Triangle of Scope, Time, and Cost means the triple constraints Quality, Schedule, and Price. “Good, fast, cheap. Choose two.”

A.W137.2 The Iron Triangle - Triple Constraints - Good Fast Cheap - Infeasible

Image Arete Consulting

Arete suggests to focus on high quality and fast schedule.

If you are a startup product or vehicle manufacturer, objectively consider whether you are truly ready for production or sales. If you are an established manufacturer, evaluate whether your program management is sufficient to bring new models to market without mistakes. For each regulation (NHTSA, PHMSA, FCC, EPA, etc.), determine if each component and system has been designed to federal requirements, tested, passed, and fully documented with test reports and company-written certifications. If you are not 100% certain and fully prepared to withstand significant failures in the field, NTSB investigation, NHTSA audit, or an entire fleet recall, then contact and engage Arete asap before any further investment toward design or production. For more information, see Terms of Use > Disclaimers and Limitations.

Contact

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A.W130.1 Flickr - Phil Varney - Great Smoky Mtns Natl Park - Newfound Gap Road

             Photo Phil Varney

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