Q U A L I T Y M A N A G E M E N T

How To Achieve
Operational Excellence
Organizations need to effectively establish,
communicate and assess their requirements
by
Madeline Bigelow

A TTAINING OPERATIONAL excellence

involves a return to the basic building
blocks of any organization: the establish-
ment, communication and assessment of
requirements. We need to make sure
requirements are clearly established, effectively com-
municated and periodically assessed to promote and
facilitate the continuous achievement of operational
excellence. We need to be sure we are providing our
major asset—employees—with the tools and mecha-
nisms they need to do their jobs right the first time.
Concepts such as reengineering, lean manufactur-
ing, just-in-time, statistical process control and Six
Sigma can significantly contribute to operations
enhancement. However, they cannot eliminate the
day-to-day operational costs that arise from devia-
tions, nonconformances and situations caused by
human error.
In today’s unpredictable market and competitive
business environment, companies are either growing
or dying. To grow, companies must be well-managed
and committed to improving faster than the competi-
tion. They also must minimize or eliminate unneces-
sary operational costs. Management must believe in
the fundamentals of quality and be committed to con-
tinuous improvement to enhance the organization’s
efficiencies and drive its competitiveness. This means
management must understand the organization’s
operations and systems well enough to recognize the
organization’s strengths and weaknesses.
There are three key goals pursued by all organiza-
tions:
• Maintain product and service quality.
• Preserve total compliance.
• Reduce quality related costs to satisfy customer
needs, ensure things are done right the first time
and remain competitive.
These goals are not reached by accident. We have to
make them happen, and the approach we take to
achieve them makes a difference in the end result.
Goal attainment is a process, not just an outcome.
It requires commitment, determination, attention to
detail and a team effort to attain these goals. I call
this the operational excellence cycle (see Figure 1).
Following the cycle, management should:
• Establish clear requirements.
• Effectively communicate established requirements.
• Continuously assess the communicated require-
ments.
Establish clear requirements
Philip B. Crosby said the first absolute in the attain-
ment of quality is to comply with requirements.1 So it
stands to reason the establishment of clear require-

70 I O C T O B E R 2 0 0 2 I W W W . A S Q . O R G
ments is the first step toward the achievement of oper-
ational excellence. FIGURE 1 Operational Excellence Cycle
Requirements come from many internal and exter-
nal sources, including state, federal and international
regulatory organizations; customers; suppliers; and
the company’s own regulations, vendor contracts,
quality agreements, corporate policies, procedures,
product specifications, test and inspection methods, 1 2
and qualification and validation protocols.
Established requirements should be clear, accurate
and appropriate for their intended purpose. For exam-
ple, written requirements need to:
• Clearly define what needs to be done, why it needs
3
to be done, where it is to be done, how it will be
done, when it will be done and who will do it.
1 2 3
• Accurately establish responsibilities, frequencies,
time frames, materials, components, equipment, Establish Communicate Assess
requirements requirements requirements
quantities, formulas, methods, measurements, envi-
ronmental conditions and documentation. Regulations Orientations Internal audits
Policies Training External audits
• Be appropriate for intended use and not impose lim- Procedures Subject matter talks Extrinsic audits
itations on the user, efficiencies and management Specifications
Methods
prerogative. For example, a requirement should not Protocols
mandate something be done on a daily basis when it Agreements
Contracts
only needs to be done prior to performance.
• Be written for the reader, taking into consideration
the reader’s age, education, experience, training,
knowledge, skills and culture.
• Clearly outline key points to be performed or fol- tors and contractors throughout the United States,
lowed. Canada and Europe. Unfortunately, I have found that
• Have pictures, diagrams, flowcharts or illustrations written operational procedures, sampling plans, test
to help facilitate the user’s understanding of the and inspection methods, product specifications, and
requirement. qualification and validation protocols either do not
• Be appropriately packaged. Show attention to page exist or are lacking some important information.
design, instructions, table of contents, index, In most companies, requirements are written,
dividers, visual layouts and the type of binder used. reviewed and approved by management or highly
• Be readily accessible to the intended users at all technical personnel who are either not the people
times. responsible for executing them or have not received
If one or more of these attributes is missing, compli- any formal training in writing requirements. Input
ance levels, product quality, efficiencies and profits from intended users is usually not obtained to ensure
could be jeopardized. The missing attribute could comprehensive knowledge from different perspectives
cause confusion, misinterpretation or undue con- is applied to the written requirement.
straints, which are usually the root causes for daily To ensure total compliance with established require-
operational errors. ments, it is vital to understand the regulations, poli-
As a certified corporate auditor for various major cies, procedures, specifications, plans, methods,
pharmaceutical companies, I have audited multiple protocols and agreements as they apply to employees’
material, component and service suppliers, distribu- assigned functions within the organization.

QU A L I T Y P R O G R E S S I O C T O B E R 2 0 0 2 I 71
H O W T O A C H I E V E O P E R AT I O N A L E X C E L L E N C E
Effectively communicate established requirements
As stated by Joseph M. Juran in his Quality
Handbook, a person is in a state of self-control only if
he or she possesses the means of knowing what is
supposed to be done.2 Therefore, the second step in
achieving operational excellence is to effectively com-
municate established requirements through one or
more of the following means:
• Subject matter talks with employees.
• New employee orientations.
• Employee training programs.
Employee training procedures should clearly indi-
cate what will be defined as a subject matter talk, an
orientation, a training, a refresh-
er and a retraining. You can fol-
low these guidelines:
Subject matter talks. Periodic
Most companies don’t limit how many
informative discussion meetings times an employee can be retrained in
intended to keep employees up-
to-date on current on-the-job the same subject matter without an
and company related matters.
Duration: 15 to 30 minutes. investigation into the root cause of the
Frequency: As determined
appropriate. employee’s inability to learn or comply
New employee orientations.
Informative discussion sessions with the requirements.
provided by the HR, quality or
engineering departments. They
are intended to give new hires
guidance and direction on general and specific subject
matters, such as company policies, regulatory require-
ments and safety rules.
Duration: One to two hours per subject matter.
Frequency: Upon employee hire.
Trainings. Formal instruction sessions to provide
employees with knowledge, skills, competence and
expertise in specific subject matters or job functions.
Duration: Two hours or more. It depends on the
nature and complexity of the subject matter or job
function.
Frequency: As determined appropriate by the sub-
ject matter training procedures.
Refreshers. Periodic reviews to keep employees
familiar with applicable regulatory, client, corporate,
company and job related requirements and revisions.
Duration: Depends on the nature and complexity of
the training subject matter.
Frequency: As determined appropriate, but should
be held at least once every two years or when subject
matter has been revised and changed.
Retrainings. Trainings offered when an employee
has committed a regulatory, corporate, company or
job related nonconformance, and it has been deter-
72 I O C T O B E R 2 0 0 2 I W W W . A S Q . O R G
mined the employee needs to be retrained in the sub-
ject matter as a preventive action.
Duration: Depends on the nature and complexity of
training’s subject matter.
Frequency: As determined necessary, but not to
exceed three times without further investigation into
the root cause as to why the training has not been
effective.
Most companies don’t limit how many times an
employee can be retrained in the same subject matter
without an investigation into the root cause of the
employee’s inability to learn or comply with the
requirements. No effort is made to identify whether
the problem is the train-
ing, the trainer or the
trainee. An adequate
employee training pro-
gram should provide for
this type of investigation.
If management takes
the time to do training
right the first time, it will
have fewer errors, devia-
tions, reworks, rejects,
returns, back orders, re-
calls and complaints, not
to mention the significant
long-term operational cost
reductions it will achieve.
Employee communication and training involve an
investment of time, resources and money. Therefore, it
is crucial certain elements be present to ensure a maxi-
mum return on investment, provide workers with a
mechanism for self-control, ensure conformance to
requirements, guarantee product and service quality,
reduce the tangible and hidden costs of poor quality
and ensure optimum levels of regulatory compliance
(see “Communicate Established Requirements”):
Trainings must be performed by qualified train-
ers. Someone who not only has the education and
experience to be a trainer, but who has also been for-
mally trained in the subject matter. Unfortunately,
many on-site trainers have never received trainer
development courses, are not familiar with adult
learning theories and have not received prior training
in the subject matter.
The current International Organization for
Standardization’s, known as ISO, standards and good
manufacturing practices require assigned functions to
be performed by employees who have the education,
experience and training to perform them.
How many times have you seen on-the-job training
performed in five to 15 minutes or found that 10 or
more standard operating procedure (SOP) training
sessions have been scheduled within a one-
hour time frame? How adequate or effective
can that be? SOP and on-the-job training
involve both a theoretical and practical learn-
ing process. They require the following generic
instructional steps be followed:
• Worker preparation. Put the worker at ease,
state the job to be learned, find out what the
worker knows (pretest), get the worker
interested in learning the job and provide
the worker with sufficient time to read the
SOP or job requirements prior to actual
training.
• SOP or job presentation. Tell, show and
illustrate one important SOP or job step at a
time; stress each key point of the job being
taught; and instruct the worker clearly, com-
pletely and patiently.
• Performance trial. Have the worker perform the
job, and constructively correct errors made by the
worker, having the worker explain each key point
as he or she performs the job again. Make sure the
worker understands the job (post-test), and have
the worker repeat the job until he or she knows how
to perform it.
• Follow-up. Put the worker on his or her own, under
adequate supervision. Encourage questions, pro-
vide feedback, and periodically check and evaluate
the worker’s job performance.
Trainings must be measured for effectiveness.
Management needs to measure and trend/track the
results of the training sessions offered, the trainers’
teaching skills and the trainees’ learning curves to
determine whether the training sessions are achieving
the desired results and the trainers are effective.
The effectiveness of the training sessions can be
measured through one or any combination of the fol-
lowing methods:
• Pre and post-testing. Measure training and trainer
effectiveness and an employee’s prior knowledge
and learning curve.
• Workshops or debates. Provide a trainee with the
opportunity to practice learned knowledge. Present
trainees with hypothetical cases and key questions
related to the subject matter.
• One-on-one discussions. Allow the trainer to dis-
cuss the subject matter, answer questions or clarify
any doubts the trainees may have.
• Performance checklists. Allow trainees to perform
the job under direct supervision and demonstrate
their ability to perform learned processes and oper-
ations.
• Progress checklists. Periodically evaluate trained
personnel to make sure they continue to perform
Communicate Established
Requirements
Valuable employee orientations, training and talks
must meet the following elements:
• They must be performed by qualified trainers.
• They must be measured for effectiveness.
• They must be appropriately documented.
the learned processes and operations.
Employee training sessions should be trended to
identify improvement opportunities. They should also
be maintained so there’s a historical reference of the
trainees’ qualifications.
Follow these training trending guidelines:
• Trend and analyze training performance and effec-
tiveness results to identify improvement opportuni-
ties and areas of concern related to employee
training sessions, training procedures, trainers and
the overall employee training program.
• Report trending results to site management for
information, evaluation and determination of
appropriate actions.
• Develop and implement action plans to address
identified training improvement opportunities and
areas of concern based on management feedback
and trend analysis results.
• Follow up, confirm and ensure the timely and satis-
factory closure of employee training action plans.
Trainings must be appropriately documented. To
show required trainings have been performed and
that all necessary personnel have attended, and to
track and follow up on the training, management
must adequately document the training sessions
offered.
Training documentation should include the training
date, training title, summary of topics covered, train-
ing’s duration, trainer’s printed name and signature,
and the printed name and signature of all attendees.
Upon review of employee training records in most
of the audits I’ve performed, I have found training
documentation does not indicate the session’s dura-
tion. There is then no way to know if adequate time
was allowed for the training process, and the
company cannot accurately assess its training costs.
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H O W T O A C H I E V E O P E R AT I O N A L E X C E L L E N C E
Most training documentation does not summarize or
indicate topics covered during the training process;
therefore, there is no way to determine what the actu-
al training consisted of. For example, in the case of an
SOP training, was the complete SOP discussed or only
changes to the SOP?
Also, many employee training records do not include
the printed names of the trainer and the employees
who attended the training; only their signatures. This
makes it difficult to assess or confirm employee atten-
dance without looking up each signature in the compa-
ny’s master signature log, assuming the company has
one and that it has been maintained.
Continuously assess the communicated requirements
To ensure compliance with communicated require-
ments, continuous assessments must be performed to
determine compliance levels, verify actual practices
and challenge the requirements’ effectiveness.
Auditing is the process by which we assess actual
conditions, compare them to established requirements
and report results to management. It is a fact finding
process by which we help our organization, suppliers
and clients identify improvement opportunities, areas
of concern, and ways to reduce quality related costs
and achieve operational excellence.
The three types of audits performed to assess com-
pliance to communicated requirements are:
• Internal first-party audits. Periodic self-inspections
performed internally to confirm, measure and
determine the effectiveness of communicated
requirements.
• External second-party audits. Supplier assessments
and audits performed to determine and confirm a
supplier’s capability, capacity and reliability to pro-
vide materials, components and services within
required specifications. These audits also investigate
the root cause of any nonconformance found in the
materials and components received from a supplier.
• Extrinsic third-party audits. Audits and inspections
performed by third parties (state, federal or interna-
tional regulatory agency investigators, client audi-
tors or corporate auditors) to determine, confirm
and challenge a company’s level of compliance with
required regulations, agreements or specifications.
The current Food and Drug Administration (FDA)
Compliance Policy Guide, chapter 1, subsection 130.300,
says, “FDA regulated industries may establish quality
assurance units to perform functions independently
from the manufacturing or quality control organiza-
tion to periodically audit and critically review its
processes and procedures to determine whether estab-
lished protocols and procedures are being followed.”3
Although most FDA regulated and nonregulated
74 I O C T O B E R 2 0 0 2 I W W W . A S Q . O R G
industries have some sort of internal audit program in
place, the audits are not necessarily independent from
their manufacturing or quality control business units.
This practice tends to significantly jeopardize and
limit the independence and objectivity of the internal
audit units, especially when it comes to auditing their
own processes and quality systems. It also creates
adversarial relationships between assigned internal
auditors and their co-workers.
To address this issue, management can either estab-
lish an independent audit department that does not
report to its manufacturing or quality departments, or
have an outsider review or assess the business once a
year or every other year. Outsiders can often see what
insiders cannot. Outsourcing professional services has
become not only an alternative, but also a necessity in
achieving operational excellence. It is an opportunity to
have an unbiased assessment of an organization and its
facilities, equipment, processes and systems performed
by qualified, independent and certified professionals.
Another problem associated with internal auditing
is that many companies will assign people who have
no formal training in auditing to perform audits. They
are unaware of the auditing requirements for each
type of audit, auditing liabilities, auditor responsibili-
ties and the actions required prior to, during and after
the audit process. Usually these employees have limit-
ed knowledge of the standards and regulations that
apply to the entity they are assigned to audit.
Furthermore, many companies do not have time
limits in place for the issuing of audit reports and
audit report responses or an effective follow-up sys-
tem for the closure of audit findings and actions. In
other words, they lack a system to report, respond to,
follow up and close the audit loop. In many compa-
nies, the auditing process is finished once the audit is
complete and the audit report is distributed. Others
do not clearly assign responsibilities and target dates
for the completion of the required actions when devel-
oping the audit action plan.
According to the FDA Compliance Policy Guide, the
FDA will not review or copy reports resulting from
internal audits performed during routine inspections
conducted at regulated entities, but it may seek writ-
ten certification such audits have been performed and
documented and that the required corrective actions
have been taken.
The action plans based on the audit results should
be developed to address areas in which improvements
can be made. The cycle then begins again through the
establishment, communication and assessment of new
requirements.
If we are to consistently ensure the quality of our
products and services, remain competitive and ensure
we are in compliance with current regulatory require-
ments, we need to identify and act on improvement
opportunities at a revolutionary pace, 4 as well as
ensure required corrective and preventive actions are
taken.

A commitment to quality
To achieve the goals of the operational excellence
cycle, organizations and management must be com-
mitted to quality, continuous improvement and total
compliance. They have to be willing to invest in the
training and development of their requirement writ-
ers, trainers and auditors to ensure requirements are
always clearly written, effectively communicated and
continuously assessed by properly trained personnel.
No matter what industry you are in or what structure
your organization may have, the principles of the
defined operational excellence cycle apply.

REFERENCES
1. Philip B. Crosby, Quality Without Tears, McGraw-Hill,
1995.
2. Joseph M. Juran, Juran’s Quality Handbook, fifth edition,
McGraw-Hill, 1998.
3. FDA/ORA Compliance Policy Guide, chapter 1, subchapter
130.300, U.S. Food & Drug Administration, 1969.
4. Joseph M. Juran, Juran’s Quality Handbook, fifth edition, see
reference 2.

BIBLIOGRAPHY
ASQ’s Quality Audit Division, J.P. Russell, ed., The Quality
Audit Handbook, ASQ Quality Press, 2000.
Friedman, Kenneth, Guide to Writing Standard Operating
Procedures, Lehigh University, 1999.
Journal of GXP Compliance, www.ivthome.com/journals.
The Small Business Journal, www.tsbj.com.
Tracey, William R., Managing Training and Development Systems,
Amacom, 1974.

MADELINE BIGELOW is proprietor and president of Operational

Excellence Services in San Juan, Puerto Rico. She earned a mas-
ter’s degree in business management from LaSalle University in
Mandeville, LA. Bigelow is an ASQ member and certified quality
auditor.

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QU A L I T Y P R O G R E S S I O C T O B E R 2 0 0 2 I 75