Determining When Quality Leaders Should Be

Involved in New Product Development

Refreshed 27 April 2022, Published 1 April 2019 - ID G00705866 - 13 min read
FOUNDATIONAL This research is reviewed periodically for accuracy.

Quality Research Team

Initiatives: Quality Management

This research helps quality leaders understand and articulate when

and how they should be involved in the early stages of new
product development based on three considerations — the degree
of regulations, how new the product or process elements are and
the potential business impact.

Overview
Costly rework due to avoidable mistakes is often a key factor leading to product launch
delays. Quality leaders want to help catch these errors earlier in the process by getting
involved further upstream. However, resourcing constraints and resistance from new
product development (NPD) project teams often prevent them from having end-to-end
involvement. Instead of pushing for early involvement on all projects, quality leaders
should decide when and how to be involved in NPD projects based on the risks associated
with regulations, how new the product or process change is and the product or process
change’s potential business impact.

Key Findings

■ Fifty-one percent of quality errors are caught after new products move past the
design phase, creating costly rework and delaying launch times.
■ Quality’s early involvement is crucial for highly regulated products and those with
many new elements because it ensures NPD teams understand how to meet the
necessary requirements to successfully bring the product to market.
■ Products with the potential to most significantly impact the bottom line require more
integrated involvement from tenured quality professionals in early NPD stages.

Recommendations

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Quality leaders deciding how to allocate resources for earlier involvement in NPD should:

■ Decide what stages to get involved in based on regulatory and novelty risks.
■ Work with business partners to determine the appropriate level of quality team
involvement based on the product or process’s potential impact on the business’s
bottom line.

Ensuring Quality Earlier in NPD

Companies are increasingly turning inward to propel growth. A majority (62%) of CEOs are
looking to drive revenue growth through new product or service launches.[1] To meet these
ambitious growth targets, product development teams are being asked to launch a higher
volume of innovative and complex new products in the same amount of, or often less,
time. In this business environment, addressing quality issues early — when fixing them is
less costly and time consuming — is a critical priority. As a result, quality leaders are trying
to get involved earlier in NPD processes. However, they face two challenges in doing so —
resistance from business leaders and limited quality resources.

Some companies believe the best way to launch products on time is involving only critical
personal during early NPD stages, so they resist quality’s involvement. This approach is
grounded on the idea that involving too many people slows things down. Conversely, other
companies recognize the value of quality’s involvement in the early stages. However,
quality struggles to meet the demand for early involvement — a problem that’s only
exacerbated with the increasing number of new product launches each year.

In either case, quality struggles to effectively provide the right level of support during the
early stages of every new project. Instead, the best quality leaders determine and
articulate when and how they should, and shouldn’t, be involved based on when they can
add more value. This approach works because:

■ Once quality clearly defines and articulates when and how it should, and should not,
be involved in early NPD stages, business partners that were initially resistant will
see the benefit of quality’s involvement.
■ It ensures quality most effectively allocates its limited resources.

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Considerations for Assessing Quality’s Involvement
When considering the quality function’s involvement in NPD, quality leaders must make
two decisions (see Figure 1):

1. When the quality function should get involved (that is, the stages in NPD that require
quality’s participation)

2. How much involvement quality personnel should have during those stages of NPD
(that is, how embedded quality should be in each step of the process and which
quality staff members should be involved).

Figure 1: NPD Involvement Decision Points

Quality decides when to get involved and the amount of involvement based on regulations,
novelty and business impact.

To determine when and how much quality should be involved in early development for
each new product or process change, quality leaders should consider three risk factors —
regulations, novelty and business impact.

■ Regulations and novelty indicate when quality’s involvement is necessary.

■ Business impact (potential gains and losses) proportionately distributes quality’s
limited resources based on the needs of the product or process.

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Deciding When to Get Involved
Deciding the NPD stages that require quality’s involvement is determined by the amount of
regulations and degree of novelty of the product.

Interviews with over 80 quality leaders show that virtually all quality functions are
involved in NPD during the final three stages — development and testing, manufacturing
and production, and commercialization. However, quality’s involvement during the first
three stages is less common. While a majority of quality organizations are involved during
the design phase, only about half play a role in concept and creation and very few are
involved in ideation.

Rather than following this benchmark or overcorrecting and getting overly involved too
early, quality needs to assess if it is involved at the right time on the right projects.

Consideration 1: Regulations
The more heavily regulated the product, the earlier the quality function should be involved.

Early involvement ensures NPD teams know the relevant regulations before the design
work begins and the potential downstream implications of changes. This prevents
commercialization delays and additional costs from rework when making required,
significant compliance changes in later stages.

Quality can help NPD teams prevent regulation issues during early stages in the following
three distinct ways:

1. Identify regulatory implications. During concept and creation, quality can identify
existing and forthcoming regulatory requirements applicable to the concept
proposal. These considerations ensure NPD teams accurately understand and
design for compliance and select certified suppliers.

2. Recommend solutions to regulatory requirements. By identifying implications early,

quality has time to help NPD teams determine what must change in the design or
component of the product to meet regulations. Quality should also use its
knowledge and skills in regulatory compliance to help identify potential solutions
(e.g., leveraging capabilities from another part of the company or upskilling a critical
supplier to ensure compliance).

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3. Find creative alternatives to apparent regulatory impasses. Finally, if quality
cannot find a way to fill compliance gaps with existing capabilities, it can use its
relationship with regulators to find alternative solutions, such as asking for
regulatory interpretations and working with regulators to change regulations. For
example, when Johnson & Johnson (J&J) wanted to move from batch production to
continuous manufacturing, it worked with the FDA to find an acceptable alternative
to historical batch testing requirements.[2] However, finding creative alternatives to
apparent regulatory impasses often requires extensive work with regulators to find
alternative ways to be compliant, so the process must start early.

Consideration 2: Novelty
The second determining factor for when quality should be involved is novelty — how new
is the change, the environment or the team for a given new product or process design?

Design problems are more likely to occur when a design project is trying something
significantly new. Therefore, the earlier quality can help NPD teams think through and
identify potential implications of the new elements of the product or process, the more
likely the projects are to succeed.

Specifically, novelty in four different areas increases the risk of failure for a new product
or process:

■ Level of innovation of the design: Is the product or its components new, unique,
different, difficult (NUDD), next generation or incremental?
■ Product’s complexity: How intertwined are the elements of the product (e.g., creating
software versus embedding software into a legacy, physical product)? And, how
much experience do product teams have with individual and combined elements?
■ Impact of the product on processes or other products: How much does each new
design element impact preexisting products or processes?
■ Level of design team experience: How much experience does the NPD team (either
internal or external) have with the company’s design process and the product it is
creating?

Products with many new elements based on this assessment require quality’s early
involvement. Table 1 highlights the activities quality should conduct in predevelopment
and testing phases for products with many new elements or processes.

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 Table 1: Activities for Quality in Products’ Predevelopment and Testing Phases
Area of Quality’s Role Example of Quality’s Actions to Decrease Risks From New
Novelty Changes

  Specification ■ Translate customer and company expectations of

Translator product quality into critical-to-quality aspects (CTQs).
 
■ Ensure design specifications are realistic given curren
  manufacturing capabilities.

 
Failure Modes ■ Identify potential failure modes (areas where a failure
Process/ Identifier could occur).

Product ■ Assess risk based on the likelihood of failure at each

failure mode.
■ Assess the impact a failure at each mode would have
on the rest of the product and/or process.

Quality Test ■ Set product approval standards and development test

Definer components that ensure products meet quality
specifications.
■ Assist in identifying ways to improve quality in design
when errors occur.

  Process Help NPD teams understand the quality processes and

Educator standards relevant to the product to ensure they are met.
 
End-to-End Set short, targeted and frequently occurring design
People
Advisor consultations to identify potential issues early, and often,
before they build up.

Source: Gartner (March 2019)

Evaluating novelty is best completed during concept and creation, allowing quality the
time to assess the proposed product and identify related requirements and processes to
ensure they are met.

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Deciding How Much Quality Is Involved
Quality’s level of involvement varies project-to-project and is determined by its associated
potential gains and losses.

Rather than assuming its level of involvement should be the same for all projects, quality
should adjust how much it is involved based on the impact the project will have on the
bottom line. This approach ensures:

■ NPD teams own as much of the process as possible.

■ All projects that require early involvement based on regulation and novelty risk
receive the appropriate level of involvement.
■ Quality allocates resources based on business needs.

Consideration 3: Business Impact

Projected gains and losses give quality clarity on how to best allocate resources to match
the impact the project could have on the business.

To determine the relative implications of failure, quality should consider two things:

1. Potential gains from a successful launch, including:

■ Forecasting the additional revenue the product will provide

■ Expected cost savings from scaling new processes created for the product

2. Potential losses from postproduction errors, such as:

■ Costs of recalls, rework and relaunch

■ Reputational damage from negative publicity due to product errors

Based on this assessment, quality should place the most attention and resources on the
products that matter most. It can do that by adjusting how many staff members are
involved, which staff members and what role they take (see Figure 2).

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Figure 2: Ways to Adapt Quality’s Level of Involvement

Quality can use three factors to adjust its level of involvement to best match the business
impact.

For new products or processes that have a higher potential to impact the bottom line,
quality should deploy more of its most experienced staff. These staff members should act
as an integrated facilitator — embedded in the project team to ask probing questions,
validate tests and facilitate quality process execution. Often, quality also acts as the final
decision maker before the product moves to the next phase. This ensures costly flaws are
caught early on in the process and allows time for changes when business partners are
more receptive to iteration.

For projects with a lower potential impact on the bottom line than other projects in the
portfolio, quality should still be involved, but fewer team members with less experience
can be involved. Given the lower risk, they also do not need to be embedded in the project
and can instead act as advisors as issues arrive. This not only creates a lower-stakes
opportunity for newer team members to learn but also frees up resources for greater
involvement for other, more financially critical projects.

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Building the Case for Involvement
A detailed risk analysis at the start of each NPD cycle gives quality a clearer picture into
when it is needed in the process and what its involvement consists of. While NPD teams
should always own the process in full, quality acts as a partner during critical stages,
providing support that matches the needs of the product. This approach helps overcome
two critical barriers quality faces in NPD — creating a compelling vision for the need of its
selective, early involvement and proportionally distributing resources based on project
needs.

Recommended by the Authors

■ “Embedding Quality in New Product Design”
While common approaches to improve early attention to design quality — such as
streamlining quality activities — are helpful, they do not go far enough. To most
effectively increase early attention to quality in new product development, quality
leaders must follow a new approach: guided ownership.
■ “Design Quality Activity Map”
Use the Design Quality Activity Map to benchmark how your organization embeds
quality in new product development and to identify critical process steps. The map
includes activities, tools and roles for key players involved in each step of the
process. 
■ “High-Frequency Design Consultations (Moen)”
Quality leaders at Moen use design consultations to uncover potential issues earlier
and more frequently than traditional reviews. This gives product developers
increased ownership over the design creation and sufficient time to solve potential
issues when it best fits their workflows.
■ “Trending Critical-to-Quality (CTQ) Design Scores (BlackDime)”
While cost and time are easy to measure, quality of a new design is less clear,
making trade-off decisions difficult. This resource allows quality leaders to track and
measure the most important quality standards over time.

Endnotes
[1] “CEOs’ Curbed Confidence Spells Caution: 22nd Annual Global CEO Survey,” PwC.

[2] “J&J Still Has Much to Explore With Continuous Manufacturing,” BioPharma Dive.

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Table 1: Activities for Quality in Products’ Predevelopment and Testing Phases
Area of Novelty Quality’s Role
  Specification Translator
  Failure Modes Identifier
Process/
Product
Quality Test Definer
  Process Educator
End-to-End Advisor
People
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Example of Quality’s Actions to Decrease Risks From New Changes
■ Translate customer and company expectations of product quality into critical-to-quality
aspects (CTQs).
■ Ensure design specifications are realistic given current manufacturing capabilities.
■ Identify potential failure modes (areas where a failure could occur).
■ Assess risk based on the likelihood of failure at each failure mode.
■ Assess the impact a failure at each mode would have on the rest of the product and/or
process.
■ Set product approval standards and development test components that ensure products
meet quality specifications.
■ Assist in identifying ways to improve quality in design when errors occur.
Help NPD teams understand the quality processes and standards relevant to the product to
ensure they are met.
Set short, targeted and frequently occurring design consultations to identify potential issues
early, and often, before they build up.
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