Development of the protocols and documentation

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1.

a. How does transactional leadership theory differ from transformational leadership theory?

b. Why is transformational leadership more relevant to quality and performance excellence?

Case Study 1- Johnson Pharmaceuticals

Johnson Pharmaceuticals is a large manufacturer that was highly motivated to meet quality challenges. It implemented an ISO 9000-compatible quality system to ensure not only FDA compliance requirements, but also customer satisfaction. As the manufacturing plants of the organization were audited by the internal audit division, it became apparent that some plants were meeting the challenge, while others continued to struggle in both the quality and regulatory aspects of production. This fact was evident in the reports of internal findings and in FDA inspection reports.

For the most part, the manufacturing plants share consistent resources and face similar environments. All were issued the responsibility of meeting the expectations of the quality system through the same mechanism. All understood the consequence of not conforming, that is, of jeopardizing their manufacturing license as bound by the consent decree. The issue then became why some plants could successfully design and implement the requirements of the quality system, whereas others could not and still cannot.

Although the plants are similar in many ways, they differ in terms of leadership, as each plant its own CEO. The CEO, as the leader of his or her plant, has the responsibility of ensuring the successful implementation of a quality system. The plants also differ in their organizational members, those who are to be led by the CEO. The relationship between the leader and the organizational members is critical to a plant's ability to implement an effective quality system, with effectiveness being a measure of how successfully a plant can comply with FDA regulations and internal quality standards.

Both plants have a similar culture that can be best described as conserving, reflecting, a level of rigidity in response to the external environment, but demonstrating organizational commitment. The strategy used by the leader in Plant A was a combination of moderate to high amounts of structuring actions, with high to moderate amounts of inspiring actions, whereas the strategy used by Plant B's CEO was a combination of moderate to low amounts of structuring actions, with moderate to high amounts of inspiring actions.

2. Answer following questions based on the case study:

a. What type of situational leadership style did the CEO of each plant demonstrate? WHY?
b. Which of these styles was more appropriate in view of the Situational Leadership model? WHY?
c. Would it be surprising to find out that Plant A was more successful in achieving the goals of the quality system?

Case Study 2- Distinguished Ad Agency

Distinguished Ad Agency (DAA) had been in business for about 10 years. It had been strong regional reputation, and counted divisions of five Fortune 500 firms among its clients. Manuel Novedad, cofounder and president, had built the firm on a foundation of client focus, adherence to a quality system, and rapid response.

One of their largest customers, a Fortune 500 consumer products company, required compliance to jointly developed protocols and a mature quality management system, but not to registration under ISO. A documented system was in place, and Novedad chaired an active steering committee. Members were department heads, including the quality manager, and the union president. System upgrades were made on a routine basis. However, this valued customer, Megaproducts, Incorporated, had missed a scheduled launch date for a new, potentially important mega-product because of miscommunications with DAA's project team and faulty ad copy, which had to be revised after being sent to the printer. These problems could have been prevented if DAA's protocols had been followed and required quality checks had been performed.

Time was factor because noncompliant product had been reaching the customer despite DAA's assurances that protocols were being followed. Much of the documentation had been written by the quality managers and edited by the president. Review by managers and supervisors, who were asked to implement applicable elements in their departments, was minimal. Consequently, many of the procedures and instructions did not reflect work realities. They depicted an ideal and were ultimately challenged as supervisors and process operators tried to implement them. But, since the clock was ticking and Megaproducts was threatening to cancel orders, implementation proceeded with promises of a complete quality management system revision once improvements were in place.

Making the quality system operable was chaotic. Managers, not wanting to appear unsure of their changed responsibilities and authority, clung to the status quo. Training -when done-focused on lower level employees, which left supervisors without a good understanding of new requirements. They were caught saying one thing but doing another. Interfaces between departments and individuals, although described in an organizational chart and statements of authority and responsibility, were not truly functional. System work-flow faltered because new relationships and interdependencies encountered old departmental barriers. Audit reports and corrective actions languished because the president periodically overrode the quality manager's authority, fearing delivery promises might be compromised. However, early implementation steps were handled well. Gaps and shortfalls were identified, and proposed solutions recommended. But, because of time, it was assumed that acceptance and adoption would be automatic. Steering committee members rationalized that everyone knew what needed to be done because solution finding had been such a fervent effort. However, like many improvement projects, concluding steps were inadequately thought through and poorly managed. Proposed solutions were not completely integrated into daily activities.

Eventually the Steering Committee realized that they lacked a comprehensive plan that would make system changes truly operational. The Committee understood that this created indecision at supervisory levels, plus inadequate coordination and dissatisfaction by those trying to make the changes workable. They saw that first-line design project managers, writers, and artists were trying to maintain a sense of order and get their work done by falling back on customary routines. Amazingly, their "stopgap" actions allowed them to get some of the Megaproducts projects back on schedule, but they realized that they must go back to the drawing board to develop a comprehensive plan. Time was running out.

Questions:

1. What mistakes did Novedad and the Steering Committee make in the initial development of the protocols and documentation and early implementation stage?

2. What were the early indications that the system was not working as planned, and why weren't improvement efforts more effectively?

3. Now that Novedad and the Steering Committee have received their "wake-up" call, what steps should be taken to revise and implement an improved, workable quality management system?

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