The document discusses ways to optimize a company's quality management system (QMS). It recommends regularly reviewing the QMS to identify gaps and areas for improvement. Companies should harmonize quality processes across business units to prevent silos and identify issues. Adopting lean principles and automating quality processes can improve efficiency. Regularly evaluating and improving the QMS through reviews, harmonization, lean techniques and automation helps enhance product safety and prevent defects.

1. Optimize Your Quality Management System
November 30, 2009
Nikki Willett
Most people say “if it’s not broken, don’t x it!” This relaxed approach is similar to how companies
look at their quality management system (QMS) today. If defects and impacts are low, and
regulatory actions are practically non-existent, and you seem to be compliant, why take the time to
optimize your QMS? It’s time-consuming. It takes resources. You have other priorities.
But, quality management is not about compliance, rather, it is all about product safety and
continuous improvement, and each time we optimize, we improve our preventive measures for
avoiding the occurrence of costly defects.
“But hey, I have continuous improvement programs, Six Sigma projects and other lean initiatives,”
you say. Although it may be true, continuous improvement programs taking aim at overly long cycle
times, variability and waste may be doing so in a silo mentality, preventing manufacturing
functions in many companies from seeing the big picture.

2. Companies that are implementing lean manufacturing programs to improve performance and
reduce costs may be incapable without predictable processes built through effective quality
management, thereby preventing many lean goals from being met. Untapped potential of quality
process automation, which may only account for only 5% to 8% of total plant costs, can still have an
enormous impact on ef ciency and quality.
Build a beacon
So what needs to be done? Build a quality beacon. Like the captain of a lighthouse, we need to climb
those stairs every night and make sure the light shines on, wide and bright, guiding us through
potential hazardous terrain and steering us in the right direction. Shining a light regularly on a
quality system can actually prevent mishaps and raise the visibility of critical trends-both bad and
good.
Starting with four sides, or elements, of the QMS beacon can help achieve on-going optimization-
system reviews, harmonization, lean principles and automation.
QMS Reviews and Gap Assessments
First, a clear picture needs to be drawn of how the business creates products across the product
value chain. Identify, de ne the value/measure and risk or critical control points in each QMS
subsystem along the business process. Assess the current practices to identify speci c gaps between
the existing operation and the quality processes by interviewing key personnel, reviewing
procedures and observing processes taking place. A comparison is made to ideal and similar
operations elsewhere, or by the identi ed risk in order to set priorities.
Start by comparing the quality plan against all of the standard operating procedures (SOPs) and
procedures around the quality subsystem, and create a simple checklist.
De ne. What problem needs to be solved?
Measure. What is the capability of the process?

3. Analyze. When and where do defects occur?
Improve. How can process capability be improved? What are the nal factors?
Control. What control can be put in place to sustain the gain?
Be careful that the SOPs and procedures are not overburdening the processes. Many times we think
that continual improvement of the effectiveness of the QMS means adding more words and
documents to make sure every little item of the process is covered. Most times, non-value added
and redundant information is added that will not be read or used.
Too much detail also means constant monitoring for changes. Too many changes or inef ciently
changing management processes can have a major impact on the operational ef ciency of the
quality management system and lead to costly issues down the line.
By doing an effective review, OEE studies and implementing the resulting identi ed improvements,
companies can avoid the costs of unnecessary setup times, materials and tasks. Variability
reduction within each key quality management subsystem will help improve ow and quality by
making the effectiveness of the operation more visible and less subject to error.
Harmonization
Silo processes and systems for quality management can lead to silo data and the inability to see
issues and trends across an organization that may stem from a single problem, such as a supplier
component used across multiple business units. However, many companies wrestle with this
challenge simply because of the culture change to bring business process users under one umbrella.
“We’ve always done it this way, why do we need to change?” is an often-raised question by each
different user community.
Harmonization does not necessarily mean identical, but alignment and compatibility of business
processes and data. Due to varying product lines, machinery and client requirements, an
organization will not be able to achieve absolutely identical processes. Companies have to take into
account global needs and the strategy of the company, as well as local requirements and resources,

4. along with the environment, culture and terminology:
Products-speci c needs for product or product families that may require some variances
Production lines-speci c needs for product manufacturing that may require some variances
Equipment-speci c needs for facilities and product lines
Location-plant sites, outsourcing and partners
Regulations-global and local governance and regulatory agencies that impact process
Suppliers-global and local sourcing impacting process
Employees and contractors-headquartered and local resources to participate, manage, use or be
impacted by new process
Language and culture-global data-entry language for reporting, date/time formats for each
locale, and terminology use across the organization
A harmonization approach can provide companies the mechanism to create a global
standardization and enforcement of its QMS while maintaining variants for local considerations.
Harmonization avoids a one-size- ts-all approach. It makes the trade-off between too many and
too few process standards and avoids inconsistencies between standards.
Getting ready for a quality management system harmonization has to start from senior
management buy-in and governance. Process standardization and harmonization need to be
explicitly stated as objectives with clear decision rules for the standardization and harmonization.
Criteria should be identi ed for selecting the best standard, based on process performance and cost,
and when process variants should not be standardized, determining exactly how common business
process can be. Efforts need to be well organized, with well-de ned plans and roles and
responsibilities for the team leading the project.
Buy-in from the top is essential, as corporate governance and executive leadership make or break
opportunities to execute dramatic cultural change.

5. Achieving consensus of harmonization requirements means involving the right individuals in the
planning stages to get the right input. Creating teams for oversight, implementation, execution and
trial/testing should be a combination of local process owners, management, end-user
representatives and IT. Teams are often the best approach for a global QMS harmonization project
but somebody needs to make the nal decision. Assign the lead decision-maker if consensus is not
achieved.
Set up a communication plan for knowledge and new idea sharing. People will be more willing to
participate if they know they are being heard.
Start small. Select one or two key quality processes to map and harmonize rst. Develop models
that offer space for local adaption. Explaining the bene t of adoption and the reason for change will
help end-users recognize how new quality process/requirements may be required to support and
align to the future state of the business process. Users of successful pilot sites will help the rest of
the end-user community adoption.
Get sign-offs. Make sure everybody understands the key requirements and aligns with nal business
processes. Without consensus on the process and key requirements, more than likely a second
major project will be needed to correct de ciencies in the rst release.
Be careful of redesigning the quality processes for harmonization with the wrong people.
Complexity of day-to-day activities must be considered when looking at harmonizing and
modifying the quality processes.
Involve experienced line-level personnel that support a speci c function. Rather than involving
senior managers, who may be far removed from current operating conditions, have them serve as a
sounding board to line personnel that are empowered to affect change.
Don’t make the mistake of mixing process change and organizational changes. Organizations are
more successful when they allow redesigned processes to be the primary driver of organizational
change. The organizational change can then be conducted to support and align with process
change.
Finally, prepare the employees for changes by investing in employee training and developing a
train-the-trainer program. This expands knowledge, reduces resistance, and produces skill and
capacity for long-term improvements. Identify measurable goals and establish key performance

6. indicators (KPIs) focusing on eliminating waste and showing the impact within and beyond the
boundaries of the enterprise. Dig into the root problems-both people and process-and look to re-
engineer the business before turning to technology to enhance the value, and you’ll end up with
successful implementations and better overall results.
Remember, a global QMS harmonization implementation is never easy. It stretches a company and
its employees professionally, personally, and at all levels.
Adopting Lean Principles
The adoption of lean principles is beginning to transform an increasing number of companies, by
fostering continuous process and technological innovation, the building of new organizational
relationships, the creation of new cooperative arrangements, and the establishment of new roles
and responsibilities. Lean quality needs to be deeply embedded for lean manufacturing to live up to
its promises of lower cost, more ef cient processes, higher pro ts and increased customer
satisfaction. A lean quality system is a system that is intolerant to waste in all its forms by creating
a culture that expects daily improvement.
Key lean principles are: perfect rst-time quality; waste minimization by removing all activities that
do not add value; continuous improvement; exibility; and long-term relationships.
Seek and destroy the fat. Exercise ef ciencies. And empower oneself with new lean fundamentals.
For lean to work, it is important not to view quality as an isolated system. Instead, the quality
system must be an integral part of the overall lean process. Quality itself can be made lean but also
drives lean improvement. By identifying and eliminating non-value-added steps, thereby
eliminating waste throughout the production cycle, companies can convert their quality system
from cost-absorbing to value-added.
Sure, lean can mean less of many things-less tasks, less cycle time, fewer organizational layers and
fewer resources. But lean can also mean more-more employee empowerment, more exibility and
capability, more productivity, more customer satisfaction and more long-term competitive success.
Lean principles for quality incorporated in the workplace today can spell business survival for the
future. Lean cannot be achieved overnight. The path to a lean quality system is incremental,
evolutionary and continuous. It requires bottom-up dedication and top-down support, but offers

7. signi cant return on investment.
Automation for Optimization
So how can automation help companies achieve a more proactive and optimized vision of a quality
system? There are several ways, including enabling companies to identify and measure the metrics
that are most critical to the quality system, allowing them to merge and analyze data across
different departments, making it easier for users to feed back quality data into design and
manufacturing more quickly.
An automated quality system helps minimize reliance on memory and on the expert. With the
shifting tides in the economy, and downsizing or re-allocating resources, an automated QMS is no
longer people-dependent. Data is real-time and is easily reproducible with reports that look alike.
Reports can be generated when needed, helping to share the knowledge faster without relying on
IT. Trends can easily be evaluated. With such information, accountability across multiple locations
is easily attained.
Cycle time can be reduced. Automated work ow, called rules engine, eliminates lengthy manual
steps. The system can easily handle multi-tasks/parallel tasks while eliminating risky copies. It
helps companies create the easy standardization and enforcement handed down from business
policies-no perception or interpretation. It also helps cross dif cult departmental boundaries-no
guessing games on who owns what-or when or who is today’s backup.
Through automation, the quality system can become a vehicle for easier collaboration, eliminating
constant and lengthy meetings. The system noti es end users quickly when they are next in the
step or when things are due. Escalations no longer become nagging phone calls as the system can
immediately escalate to the manager for overdue tasks vs. the manager constantly asking questions
about the company’s current state.
However, adapting a QMS technology to existing processes can only lead to broken process
happening sooner. Most work processes are created over time to support the existing paper-centric
environment. Attempting to modify software, whether packaged or custom-built, to support
existing work processes will lock in all the inef ciencies in the current environment.
Don’t rely solely on IT to conduct testing. IT needs to partner closely with operations stakeholders

8. to conduct the testing which can also serve as a train-the-trainer opportunity. Make sure the
appropriate amount of time is provided for not only the software training, but the new process
training as well. Don’t burden personnel with having to teach themselves. Self-instruction on new
processes rarely produces adequate results.
By optimizing your quality management system (QMS), companies can achieve tangible ROIs such
as:
ef cient use of resources
rapid cycles
higher quality at lower cost
greater exibility
sustainable processes
Finally, understand what controls can be put in place to sustain the gain. Optimization, lean,
continuous improvement programs are not just one-time projects, but a continuous cycle for
improving your quality management system.
Remember, even a small change in ef ciency could save money. Q
Tech Tips
A clear picture needs to be drawn of how the business creates products across the product value
chain.
Harmonization does not necessarily mean identical but alignment and compatibility of business
processes and data.

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Nikki Willett is vice president of product marketing and
regulatory affairs, Pilgrim Software Inc. (Tampa, FL). For
more information, e-mail willettn@pilgrimsoftware.com
or visit www.pilgrimsoftware.com .
A lean quality system is a system that is intolerant to waste in all its forms by creating a culture
that expects daily improvement.
An automated quality system helps minimize reliance on memory and on experts.