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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-

ments is the first step toward the achievement of oper- ational excellence. 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, 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 to be done, where it is to be done, how it will be done, when it will be done and who will do it.

• Accurately establish responsibilities, frequencies, time frames, materials, components, equipment, quantities, formulas, methods, measurements, envi- ronmental conditions and documentation.

• Be appropriate for intended use and not impose lim- itations on the user, efficiencies and management prerogative. For example, a requirement should not mandate something be done on a daily basis when it 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- lowed.

• Have pictures, diagrams, flowcharts or illustrations to help facilitate the user’s understanding of the requirement.

• Be appropriately packaged. Show attention to page design, instructions, table of contents, index, dividers, visual layouts and the type of binder used.

• Be readily accessible to the intended users at all times. If one or more of these attributes is missing, compli- ance levels, product quality, efficiencies and profits could be jeopardized. The missing attribute could cause confusion, misinterpretation or undue con- straints, which are usually the root causes for daily operational errors. As a certified corporate auditor for various major pharmaceutical companies, I have audited multiple material, component and service suppliers, distribu-

FIGURE 1 Operational Excellence Cycle 1 2 3
Operational Excellence Cycle












Internal audits



External audits


Subject matter talks

Extrinsic audits






tors and contractors throughout the United States, Canada and Europe. Unfortunately, I have found that written operational procedures, sampling plans, test and inspection methods, product specifications, and qualification and validation protocols either do not exist or are lacking some important information. In most companies, requirements are written, reviewed and approved by management or highly technical personnel who are either not the people responsible for executing them or have not received any formal training in writing requirements. Input from intended users is usually not obtained to ensure comprehensive knowledge from different perspectives is applied to the written requirement. To ensure total compliance with established require- ments, it is vital to understand the regulations, poli- cies, procedures, specifications, plans, methods, protocols and agreements as they apply to employees’ assigned functions within the organization.












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:

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

• 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 informative discussion meetings intended to keep employees up- to-date on current on-the-job and company related matters. Duration: 15 to 30 minutes. Frequency: As determined appropriate. New employee orientations. Informative discussion sessions

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-

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.







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-

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.

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

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.












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







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.




Philip B. Crosby, Quality Without Tears, McGraw-Hill,

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.


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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