Basically, there are two overall approaches to developing a new product or service: (1) get a bright idea, dive in, create a few items, and see if anyone is interested enough to buy one, or (2) define the idea, examine the feasibility of producing the product or service, test the marketplace for salability, make a go/no go decision. If go, detail the production and launching plans and track the development through every step, making corrections, both to processes, production quantities and to the product/service itself, as needed.

The landscape is littered with misjudgments, overshadowed by the overwhelming successes of the fortunate few. Unrealistically, the realm of product or service development is often not on the radar for QMS auditors. Product or service development may be viewed as primarily a creative process not subject to the protocols and procedures of product realization, and perceived as not a “process” to be audited and critiqued. It’s the world of inventors, the risk-takers, the visionaries, a world not often accepting of organizational constraints (and auditors).

But, unless we envision two unshaven, sleep-deprived geniuses tinkering in an unheated garage creating the ultimate machine to crack the space-time continuum, the informed organization would see product or service development as a rational process, a process that would benefit from auditing and improvement. Yes, a few bountiful trees have successfully grown from tiny nuts. However, in the context of an ongoing organization contemplating expansion with a new product or service, there are a myriad of constraints to consider, such as market, money, capacity, resources, etc.

If not already done, your first role may be to demonstrate to management why a rational approach to product or service development is the smart approach, how the approach should benefit the customer segment for which the product or service is intended, and the approach’s profitability for the organization. In taking on this role, you come armed with quality principles, a portfolio of proven quality practices, pertinent examples of the value of rational thinking, and your best interpersonal relationship skills. You probe for in-house examples or competitors’ examples of missteps taken in choosing, designing, and launching a new product or service. And, you shape your informative questioning from the list in this article, augmented from your experience in the organization and industry, all with a focus on what is particularly meaningful to the people you are approaching. It may not be easy to convince the wizards of Oz to give up the trial-and-error concept—but you can do it.

Outline of Questions for Auditors to Consider for Their Checklist

Is this product/service idea feasible?

• Is understanding of the marketplace sufficient?
  1. What is the basis of for thinking that this idea makes sense to pursue?
  2. Is formal market research needed before proceeding?
• Where does the proposed idea fit strategically?
  1. Near-term or long-term strategy?
  2. Have one or more strategic objectives been established?
• What are the potential risks?
• What is the potential impact to the organization?
  1. Increased customer satisfaction?
  2. Improved profits?
  3. Environmental improvement?
  4. Enhanced organizational image?
  5. What segment of the present customer base would likely buy it?
  6. What new segment(s) could be attracted to buy it?
  7. Do we presently have the knowledge and skills to produce it?
  8. Do we presently have the capacity to produce it?
  9. Are there any present or potential laws, regulations, ethics, industry standards, and cultural norms that could adversely affect success?
  10. Who are the real and perceived competitors?
      • Our own products and services?
      • Inside same industry?
      • Outside our industry?
      • Global competitors?
  11. If produced, what is or could be the effect on our present products/services?
      • Will the proposed product/service:
        1. Upgrade existing products/services?
        2. Replace or make obsolete existing products/services?
        3. Displease present customers?
        4. Substantially alter present customer base (+ or -)?
      • Have we over-emphasized the positive impacts of developing this idea and not sufficiently probed the negative impacts?
• If it appears feasible and logical is the organization really going to do this?
  1. Is the present organizational structure appropriate for the potential magnitude of the initiative?
     • Should a special team (task force) be organized and operate as a parallel organization until the implementation is deemed complete and successful? If so:
       1. To whom should the project team report?
       2. Where should the project team be physically located?
       3. What disciplines, skills, and experience should be represented on the team? How many members?
       4. What additional training will members need:
          • Team dynamics?
          • Interpersonal skills?
          • Project planning and management skills?
          • Communication protocols?
          • Technical skills?
          • Product/service subject matter knowledge?
  2. Should separate project teams be formed for each of three phases?
     • Feasibility?
     • Product/service development?
     • Product/service launch?
• How much and from where will funding be needed?
• Is it best to do a trial run or jump in without “testing the water”?
  1. Models for product development include:
     • Build, test, and fix mode?
     • Staircase mode—specific phasing of development for design, fabrication, test, and integration, coupled through feedback?
     • Prototyping mode—to help define requirements where the customer does not fully know what they want or need?
     • Spiral mode—using three prototypes and multiple iterations of design concepts and refinements, the process is portrayed as a spiral converging on a final design, and then proceeding to the staircase mode?
     • Rapid development mode—recognizing that product operational behavior needed to be experienced in order to fully develop product requirements?
  2. What additional resources are needed for whatever approach is selected?
     • Are these resources available now or will sources have to found or developed?
  3. Will substantial changes to our present procedures, processes, safeguards, etc. be required?
  4. Is the proposed product or service such that an extreme degree of confidentiality will be needed until we are ready to launch?
  5. What are the risks during this stage?
• Assuming the decision is to proceed, what is the process needed to make it happen?
  1. What are the requirements and risks pertinent to each of the process steps:
     • Design?
       1. Is the necessary in-house design expertise available?
       2. What additional resources and capability is required?
       3. Are there any legal requirements or issues to consider?
     • Produce the product or service?
       1. Are the needed personnel, facilities, equipment, space, etc. available?
       2. What additional human resources and capability is required?
       3. Are suppliers identified and arrangements made?
     • Conduct a trial launch?
       1. Produce short run of product or conduct test runs of service?
       2. What risks are pertinent at this stage:
          • Risk of divulging plan to competition?
          • Risk of damaging customer perceptions if trial fails?
          • Risk of waste?
          • Assess against criteria to be met before a full launch?
            1. What criteria? Who develops?
       3. Go or No Go decision?
          • If no go:
            1. Risk of organization’s reputation being damaged when launch fails?
            2. Cost to re-engineer or scrap?
            3. Financial impact if launch delayed or canceled?
     • Full launch?
       1. Sequential, time-phased launch?
          • Where, with what territory, what customer segment(s)?
          • Deployment process and support through initial introduction (within each phase)?
     • All-at-once launch?
       1. Is everything and everyone ready for simultaneous launch?
          • Product/service ready?
            1. Sufficient product produced?
            2. Stock replenishment plans in place (to keep the “pipeline” full)?
            3. Services ready to deploy?
          • All required permits, inspections, and regulations have been met?
          • Training completed?
          • Advertising/notifications ready?
          • Sufficient trouble-shooting personnel have been trained and are available for deployment if needed?
     • Post-implementation assessment?
       1. Overall strategic objectives met?
       2. Preventive actions initiated if needed?
       3. Lesson learned documented?
       4. Refresher training and/or remedial actions initiated as needed?
       5. Long-term commitment made to continually improve processes, product/service?

What types of reviews should be considered during the process?

• Basic formal reviews:
  1. Product requirements review?
  2. Preliminary design review?
  3. Critical design review?
  4. Production part approval review?
  5. Test readiness review?
  6. Pre-ship review?
• Basic informal reviews:
  1. Documentation critique?
  2. Walkthroughs of (types/topics overall):
     • Statement of functional requirements?
     • Non-technical summary of requirements?
     • List of end-requirements traceable back to each system’s functional requirement?
     • Description of interface requirements—connections?
     • Assurance that requirements are testable and method to test?
  3. Walkthroughs (design topics):
     • Complete description of design?
     • Assurance that algorithms meet required functions and computations?
     • Assurance that the design is traceable to overall requirements?
     • Documentation of complete design?
     • Description of all error detection and handling procedures and mechanisms?
     • Description of interface design?
  4. Walkthroughs (software topics):
     • Assurance that program coding meets the design requirements?
     • Program is structured to effectively meet ease of use as well as ease of future updating?
     • Comments are documented and sufficient for an unfamiliar reader?
     • Program language is correctly and effectively used?
     • Factors and formulas are correctly programmed and tested?
     • Design documentation is up-to-date and complete?
  5. Walkthrough (post-implementation topics -not to be confused with formal audits or assessments):
     • Product/service is meeting the overall need or niche intended?
     • Implementation of product/service was accomplished effectively and by the established plans?

Additional audit checklist questions

Management support:

• Is the new product or service development part of the organization’s strategic plan?
• Does the project to design and launch a new product or service report to a top management person?
  1. Is that person actively involved in on-going support of the project?
  2. Are the project team members representatives of the functions that will be involved or impacted by the new product or service?
  3. Has a feasible return-on-investment been estimated and accepted?

Tools and methods used:

• Are commonly accepted project planning and project management tools and methods effectively used?
• Is a design failure mode and effects analysis (DFMEA) used effectively, if applicable?
• Is a design for manufacturability and assembly (DFMA) used effectively, if applicable?
• Have design review procedures been established and used effectively?
• Are there effective control plans for all phases from feasibility study > product/service design > production process > product/service launch > measurement systems analysis > reviews in use?
• Are standards established for: engineering specifications and drawings, material specifications, drawing and specification changes?
• If product or service is in response to an expressed customer-need, is the voice of the customer appropriately cascaded through the stages of development and delivery?

Conclusion

Team-based product and service development does work. The benefits are: going to market faster, serving customer needs or wants, quality principles and practices are applied throughout the process, organizational strategy is achieved, probability of errors of omission are absent or decreased, the product/service is produced within budget and on time, the team learns and passes on knowledge for next time, and a successful launch and future sustainability creates satisfaction for all involved.

Additional information sources

Russell T. Westcott is an ASQ Fellow, certified quality auditor, and certified manager of quality/organizational excellence. He edited The ASQ Certified Manager of Quality/Organizational Excellence Handbook, third and fourth Editions (ASQ Quality Press, 2005), and co-edited the ASQ Quality Improvement Handbook. Westcott authored Simplified Project Management for Quality Professionals (ASQ Quality Press, 2005), and Stepping Up To ISO 9004:2000 (Paton Professional, 2003). He is active in ASQ’s quality management division and the Thames Valley, Connecticut section management. Westcott instructs the ASQ certified manager of quality/organizational excellence refresher course nationwide. He writes for Quality Progress, The Quality Management Division Forum, The Auditor, and other publications.

Westcott is president of R.T. Westcott & Associates, founded in 1979, based in Old Saybrook, Connecticut. He guides clients in implementing quality management systems, applying the Baldrige criteria, strategic planning, and project management practices.