By Jean White, Qualidoc

Training is everything. The peach was once a

bitter almond; the cauliflower nothing but cabbage with a college education.” –Mark Twain in Pudd’nhead Wilson’s Calendar, 1894

Organizations entering the quality system arena through standards such as ISO 9000 and AS9100 might find that, although training is not everything, they will need to increase their training resources. While senior executives acknowledge the need for train-ing, they might not regard it in the same critical light as business processes such as marketing or production.

Inadequate or neglected train-ing, however, can have a serious effect on the certification status of the organization. Standards boards such as the American National Accreditation Board and the Standards Coordinating Committee have warned that “incomplete reports will no lon-ger be tolerated”—“incomplete” meaning, among other things, nonconformance reports closed out without sufficient root cause analyses. The boards suggest that unsatisfactory training could be a root cause along with ambiguous procedures and working instruc-tions. They are adamant that they will not accept root causes based on “employee error, human error, operator error or anyone else who made an error.”

Given these constraints, it can be difficult and time consuming to decide what sort of training is

required. Above all, a quality sys-tem should be a healthy discipline, not a straitjacket. Some training needs might be obvious, such as recognizing counterfeit or suspect parts, different reporting require-ments, new documentation or pro-cesses, or the difference between containment, and corrective and preventive action. Others are more subtle, such as introducing unfa-miliar concepts and obligations to employees who often believe the quality system is management’s business.

Employees must be confident about their responsibility and authority, and be committed to the success of the quality system. Clearly, the certification bodies and standards boards expect the certifi-cation audits to reflect this commit-ment. Employees at all levels should be able to answer qualified ques-tions about their work, especially if they are questioned in unfamiliar circumstances such as the assess-ment for certification. Consider an example from the draft ISO 9001:2015 (ISO underlined words for emphasis):

Clause 5.1—Leadership and com-mitment: “involving, directing and supporting persons to contribute to the effectiveness of the quality management system.”1

Lack of training can show up during the audit when the asses-sor might ask anyone questions such as: “Can you show me your working instructions?” A relaxed, well-trained employee will refer the assessor to the master docu-ment list (also known as the quality system document index) and the relevant documents without floun-dering.

Training becomes less onerous when trainees discover they con-

tribute to the quality system, but getting this kind of cooperation is not always easy. One long-term employee (I will call him Louis) fol-lowed me around the shop floor on each of my site visits, muttering about trade union intervention. He even produced a tape recorder at one of my training sessions. As work progressed on the quality sys-tem, however, Louis became a fan. He made some useful comments on the draft procedure, which our organization was able to incorpo-rate into a working instruction. In his interview with the assessor, he conducted himself well and empha-sized the importance of the weld-ing procedure. I was impressed.

Unfortunately, Louis forgot advice not to talk too much dur-ing the audit. Before preparing his report, the assessor decided to wan-der around the shop floor again. As a result of another encounter with Louis, he asked to see the pur-chase order for the welding rods. The organization had a purchase order with a standing order for welding rods, but it was 15 years old and had never been reviewed or revised. It had no specification on it or quality assurance requirement. The assessor regretfully issued a minor nonconformance, and I was left with a very red face.

I hasten to point out that attempts to train employees to respond in parrot-fashion to an auditor’s questions are doomed. As long as they are trained thoroughly in the day-to-day processes and they know how to answer questions about their work (questions that might not be phrased in familiar terms), the audit should not reveal ambiguities in the quality system or extend into assessment overtime.

While comprehensive training is

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Tackle Training Before the Audit

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“

By Daniel Zrymiak,Accenture

T he U.S. Food and Drug

Administration’s (FDA) 2004 final ruling titled “Bar Code Label Requirements for Human Drug Products and Biological Products” was projected to result in more than 500,000 fewer adverse events during the next 20 years. Thus, the FDA esti-mated a 50% reduction in medica-tion errors. The FDA elaborates on this subject in its 2010 Guidance for

Industry: Bar Code Label Requirements Questions and Answers document.1

According to 69 FR 9120, the FDA published a final rule requir-ing certain drug and biological products to include linear bar codes and machine-readable information on drugs, biological products, and labels for blood and blood components. The intent is to help reduce the number of medica-tion errors that occur in hospitals and healthcare settings, including nursing homes. The scope of this ruling includes manufacturers, repackers, relabelers and private label distributors. Noncompliance will represent a “misbranding”

regulatory violation.The FDA final rule requires the

use of a linear bar code and does not restrict organizations from add-ing other technologies (such as two-dimensional symbology and radio frequency identification chips), unless an exemption is formally requested and approved. This essen-tially locks down linear bar codes as the acceptable standard technology to represent product data. Specific approved machine-readable bar code symbology standards include Codabar and ISBT 128 protocols. As an automated data capture method, bar codes provide organizations with a rapid and inexpensive improve-

necessary for full-time employees, it is neither necessary nor required for temporary employees. They might be hired for eight hours at a time. It is not reasonable to expect supervisors to spend four of the eight hours explaining a quality system. Instructions are usually con-fined to “This goes here, that goes there, check with Joe Smith, the foreman, if you have any questions.” These conditions can be found in any industry or service. Just ensure that the certification body is aware that temporary employees could be on site at the time of audit.

Training at more senior levels has its own pitfalls. My clients some-times assume that training the qual-ity assurance manager (QAM) to be a manager is part of my job as a con-sultant. I expect to train the QAM incumbent or candidate in quality system requirements, but I can’t make managers out of them if they haven’t the potential. I’m reminded of one purchasing manager who, on returning from sick leave, was told he had been appointed QAM. He

had neither the strength nor the inclination to take on those respon-sibilities so had to be replaced. This was not good for morale.

QAMs must be able to balance the requirements of the quality system and the practicalities of the business, and have a mature out-look when handling employees. QAMs often have other responsi-bilities that have to be given priority at times. The strain can be eased by delegating tasks, such as main-taining the master document list, as long as the delegated authority is shown on the organization chart.

Training can take many forms. I encourage my clients to avoid slogans and mission statements. I asked one QAM to prepare a notice for the large nonconforming product segregation (quarantine) area of a warehouse. I discovered that his idea of a notice was an 8 x 8-inch piece of paper with a vis-ibility of about two feet. It pays to think about: Who needs to know? What do they need to know? When do they need to know and where?

Training is an important part of quality standards implementa-tion. It requires alert participation from all employees. We don’t want them to discover their involvement for the first time at assessment. Assessors do not take kindly to train-ing plans that have been hastily con-trived or postponed through lack of time or funds. If the training plan is given the attention it deserves, it won’t become an immediate casualty if resources are strained temporarily. As a bonus, auditors will appreciate being spared the embarrassment of reports returned by the certification body because of “insufficient root cause analysis.”

REFERENCE

1. International Organization for Standardiza-tion, ISO 9001:2015 Draft International Standard, Clause 5.1—Leadership and commitment.

JEAN WHITE is a quality management consultant at Qualidoc in Cheltenham, Gloucestershire, U.K. White has a bach-elor’s degree in English language and lit-erature and is a member of ASQ.

Beyond Bar Codes

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ment over manual methods. To realize the desired improve-

ments in patient safety and error reduction, bar codes must comple-ment lean Six Sigma initiatives emphasizing risk management, safe-ty analysis and process engineering.

Understanding bar codes

The correct preparation and suc-cessful deployment of bar codes require their own level of require-ments analysis and subsequent vali-dation. Only after these needs are identified and fulfilled can bar cod-ing support improvement initiatives.

To appreciate this position, it is important to first understand the composition and functionality of bar codes. Bar codes use symbols to represent information which, due to international inconsistencies, may generate misleading or incor-rect data. The information must be readable and protected from dam-age or deterioration. An unread-able bar code potentially causes delays as the healthcare practitio-ners must repeat bar code scans or revert to manual data capture methods. Business rules are neces-sary to make the data meaningful.

For example, different regions use different formats for how dates are indicated (such as dd-mm-yyyy or mm-dd-yyyy). Other issues include names with special characters (such as accents and apostrophes), truncation or partial matches. For the consistent and correct capture of data, business rules must be established and con-sistently applied.

The FDA guidance document suggests that linear bar coding will be sufficient to generate the desired improvement in patient safety and risk mitigation. Consistent processes that continually assess the biological, chemical and physical risks of the

substance or specimens, along with appropriate controls, are needed to mitigate those risks with timely alerts and warnings. Bar coding supports improvement by ensuring consistent data capture at appropriate control points in the process.

Using lean and Six Sigma

To have a stable process that ensures patient safety, lean and Six Sigma techniques are required. Value stream mapping is a lean technique in which the processes are analyzed to determine the value points, constraints and areas of waste. After the redundant or nonessential steps are removed, the process can be suitably prepared for further application to improve patient safety. Product and process hazard analysis is conducted to determine the items of greatest risk.

Techniques such as a failure mode and effects analysis can highlight and quantify hazards and determine the anticipated effect on the patient or specimen involved. Following process and hazard analysis, suit-able mitigations can be determined and prioritized. Bar coding—along with the other mitigations—can be incorporated into a revised and re-engineered process.

Process improvements must be validated and controlled, ensuring that the core purpose of the pro-cess is fulfilled and no new issues have been introduced. Process con-trols can be demonstrated by the audit trail of records necessary to prove correct process completion. Automated data capture using bar coding or any other format depends on correctly uploading data to the intended database fields for valid analysis and archiving. Long-term benefits only can be realized through a deliberate improvement initiative such as lean or Six Sigma.

After defining and measuring performance (incidents or near-misses, in the case of patient safety), a Six Sigma team can analyze, set targets and make improvements. The improvement steps will most likely require more than just imple-menting linear bar coding data capture, such as revising processes, conducting training, deploying additional resources, and adopting more visual indicators.

By engaging a process expert to work alongside the healthcare prac-titioners, the ideal processes will be defined and supported, fulfilling the necessary transactions and pre-serving patient safety. Technology solutions can be formed by col-laborating with the biomedical engineering and information tech-nology groups. Process expertise can be readily obtained.

For example, the ideal blood transfusion process was defined in 2003 in the Serious Hazards of Transfusion (SHOT) program by Mike Murphy and colleagues at John Radcliffe Hospital at Oxford University. This process defines the critical points where neutral data capture technology can be intro-duced to offset the process and product risks associated with blood transfusion.

A professor of blood transfusion medicine at the university, Murphy said, “We’ve looked very carefully at the hospital’s transfusion process, which is very complex and involves many staff. We’ve broken this down into a series of simpler steps and designed the software around them. The new system now means that one nurse is prompted to carry out 14 checks, where it previously required two nurses following 27 stages making paper records. It’s safer, it’s less time consuming and we know that staff prefers it.”

This is a successful example of

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first determining the hazards of a medical procedure, defining a process, and applying bar cod-ing technology to fit the process. Because the process was defined first, bar coding was successfully applied. Alternatively, if the pro-cess steps or business rules were compromised or neglected, bar coding alone would not ensure patient safety. Bar coding requires suitable and compatible tech-nology, symbology, interfaces and business rules for correct operation. Bar coding is worth-while and applicable only when incorporated after hazards have been analyzed and mitigated, and sound processes have been

defined with critical control points for the timely application of data capture.

Ultimately, patient safety is best guaranteed by removing risks and hazards at their root cause. This is the essence of Six Sigma and the only way to achieve the target of 500,000 fewer adverse events dur-ing the next 20 years and a 50% reduction in medication errors. There is no “silver bullet” tech-nical solution to achieve these goals. Only through a carefully considered, continually updated sequence of analysis and regular improvements of medical pro-cesses is the best hope for better patient safety.

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NEWS SIXSIGMAFORUM

Plans Underway for 2015 Lean and Six Sigma Event The 15th annual ASQ Lean and Six Sigma Conference will be held March 2-3 in Phoenix.

Organizers are planning various activities around the conference theme, “Leading the Quality Journey Through Lean and Six Sigma.” Focus areas at the con-ference include:

• Lean and Six Sigma fundamentals.• Implementing lean and Six Sigma.• Nontraditional applications of lean and Six

Sigma.• Sustaining results.• Establishing and sustaining a culture of quality.Before the two-day event’s formal programming

begins, the Six Sigma Forum plans to host a recep-tion on Sunday, March 1, to give conference-goers a chance to meet keynote speakers, fellow attendees, as well as sponsors and exhibitors.

A speed-networking session also is in the works to occur sometime during the conference. At this activity, participants will rotate through a series of stations with prescribed questions, aimed to help people make new connections and share experiences

related to the conference theme and focus areas.Keep tabs on all conference updates, including

details on keynote speakers, presentations and workshop sessions, by visiting http://asq.org/ conferences/six-sigma/index.html.

Case Study Focuses onSix Sigma, Army ProjectASQ’s Knowledge Center has released a new case study related to lean Six Sigma.

The study describes a define, measure, analyze, improve and control project involving a U.S. Army contractor working to improve vehicle inspection standards.

You can read the entire case study at http://asq.org/2014/06/six-sigma/uniform-inspection-standards.pdf.

Earlier this year, the Knowledge Center released another case study describing how Max Life Insurance Co., headquartered in New Delhi, India, used Six Sigma and quality tools to improve customer retention.

You can find that case study at http://asq.org/2014/05/six-sigma/life-insurer-improves- customer-retention.pdf.

REFERENCE

1. U.S. Food and Drug Administration, Guidance for Industry: Bar Code Label Requirements Questions and Answers, 2010, http://bit.ly/guidanceforindustry.

DANIEL ZRYMIAK is a mobilization lead at Accenture in Vancouver, British Columbia. He holds a bachelor’s degree in commerce with honors in marketing from the University of Saskatchewan in Saskatoon. Zrymiak is an ASQ fellow and an ASQ-certified quality auditor, hazard analysis and critical control points auditor, biomedical auditor, engineer, manager, Six Sigma Black Belt and software quality engineer. He is also a QMI Canada-certified environmental management systems lead auditor and quality systems lead auditor. Zrymiak is an ASQ Quality Press author and reviewer, regional director for ASQ Region 4 (Canada) for the 2015-2016 term, and active with the Quality Management Division’s finance and governance technical committee.