SITUATION 

A Four Hundred (400) person R&D Facility, part of a 2 billion dollar per year Medical Device Company, required a solution for the following problems:

1. Maintenance requirements for equipment where causing unacceptable impact on facility operations
2. Lab techs lack sufficient regulatory knowledge leading to QA violations
3. Maintenance plans and work execution did not meet SOP requirements
4. Unacceptable levels of potential rework on critical equipment
5. Inefficient methods of executing cost control or work history retention for maintenance program components

APPROACH

Our proprietary approach incorporated equipment validation, equipment criticality reviews and several risk-based programs to achieve the results required by our client. We implemented a centrally managed work control process, enabled by our proprietary data management system. A team of Subject Matter Experts and Technical Staff in the area of regulatory compliance and maintenance work control with support from client leadership and staff implemented an integrated maintenance best practices and validation information into a robust fully compliant maintenance program designed for maximum reliability at reasonable cost. 

 SCOPE OF WORK

We initiated our process which combines regulatory and maintenance process experts to aid understanding work management and control needs of the client.  The process began with the development of a maintenance plan and master equipment list (MEL) with assigned criticality. Critical compliance and work practice information was loaded into a project data management system for each component in the plan. Each subsequent piece of equipment was entered in this manner. The next step is to conduct life-cycle analysis for each record in the MEL by first developing maintainability reviews from equipment specifications and procurement documents and subsequent criticality categories for cGDP components and other process/utility equipment. Based on the criticality review, specific maintenance plans were developed and converted to PM tasks from existing IQ and OQ protocols, manufacturers recommendations and/or warranty requirements. Based on criticality reviews conducted we were able to ensure calibration and PM task frequencies were optimized for cost and regulatory impact. The next phase was to develop an approved network of service providers and vendor support for equipment groupings. The final element was to complete knowledge transfer to client staff to ensure sustainability.

MAINTENANCE PROGRAM PLAN

The initial step was to establish Maintenance Plan for the maintenance and configuration control process.  The plan included a complete inventory of all required equipment and all recurring maintenance tasks.  The Maintenance Plan assisted in integrating the prioritization of project elements and manpower resources.  Our Implementation Manager supported by validation and maintenance program experts provided the configuration control function for this plan.

PROJECT DATA MANAGEMENT SYSTEM (PDMS)

The entire maintenance process was enabled at start up by our proprietary data management system.  The system supports basic accounting and reporting functions, plans, schedules work, approved service provider records provide critical data to all stakeholders, collect metrics for continuous improvement, and functions as the going forward the compliant work control process. 

Client staff gained on-line access to maintenance support information like work status, cost and regulatory information. Our methods, processes, and technology became part of the business environment and culture through the data management system.

KNOWLEDGE TRANSFER

We partnered with the client to implement our maintenance program approach with a focus on knowledge transfer.  The integrated package of risk-based technology and support services that includes 400 benchmarked best practices was instrumental in establishing process control. 

The approach to managing day-to-day work and interfacing with the site team included planning, execution, and continuous improvement.  We utilized the underlying PDMS system to enable the entire process and provide demand-driven information. Prior to systems turnover all maintenance and operations critical information was thoroughly reviewed by the client staff through effective on-the-job training. Our implementation methods drove new behaviors in a learn-by-doing environment.

METRICS

The third part of our approach was to support the new process by a suite of metrics to ensure effective decision-making and compliance is maintained. We worked with senior management to establish new performance measures and identified the metrics that were used. The effectiveness of the model will be driven by the accuracy of measured performance and the effectiveness of data based maintenance and compliance based decisions.

OUTCOMES 

• Fully implemented maintenance system for work control with full online access to critical information needed to assure compliance and cost control.
• Established a fully compliant and sustainable system.
• Implemented an effective Preventative Maintenance program.
• Knowledgeable and informed staff/knowledge transfer
• Ability to schedule maintenance around operations schedules
• Identification of process equipment criticality
• Control of service providers and vendor support
• Increased lab tech availability to technical related jobs  
• Merged two traditional manager roles to one

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One of the many factors that have been recognized as the hallmarks of successful management behavior is the ability of Managers and Executives to develop their Direct Reports and staff. This attention to and interest in their professional growth is perhaps the most significant factor in the loyalty and commitment of personnel to their company.

However, the design in the majority of management development  programs omits the details of how Managers and Executives are to accomplish staff development, though their performance evaluation frequently includes how well they perform in this respect.

The intent of most management development programs is to broaden the individual’s view of what constitutes good management practice, with the expectation that the insight the Executive acquires will lead to the development of talent among his or her staff. They are expected to apply this knowledge without further training. What is not stressed is the formal coaching of these future leaders in the “how” of how to develop the talent of staff members.

There are at least two responsibilities of the Manager and Executive that can interfere with the coaching process:

<!–[if !supportLists]–>·         <!–[endif]–>The Manager has to evaluate staff members and judge their performance and competency.

<!–[if !supportLists]–>·         <!–[endif]–>The Manager is responsible for achieving the strategic goals assigned her department

These responsibilities can result in a host of contradictory aims that may interfere with the employee development process.

Our program, Coaching Managers to Become Coaches, is designed to help managers not only successfully realize their goals and expectations as managers, but also to develop their ability to develop their staff.

 THE PROGRAM

 (A). THE ELEMENTS OF THE PROGRAM

The following are the major ingredients of our program. They comprise what a Coach or Executive needs to possess to be successful.

          (1).     Understanding of self and one’s impact on others, and, a desire to continual learn about oneself.

          (2).     Understanding others and their personalities, including:

        (a).     Recognizing the strengths and talents of his/her Direct Reports.

        (b).     Recognizing the limitations and personal impediments of each Direct Report.

        (c).     Being able to diagnose personality problems that require forms of intervention other than coaching.

        These abilities are succinctly captured in the chart (below) devised by those in the “emotional intelligence” movement.

          (3).     Developing a team which involves:

        (a).     Understanding team dynamics.

        (b).     Conveying goals, expectations and priorities clearly and directly so that the entire team is pulling in the same                   direction; creating a strategic vision that is both compelling and motivating.

        (c).     Ensuring that the team knows how its performance is related to the overall corporate objectives and strategy.

EMOTIONAL INTELLIGENCE

          (4).     Making assignments (as appropriate) to both individuals and teams: The list of tasks and their descriptions are offered as an important part of the developmental planning process of the Center for Creative Leadership. Types of assignments:

              (a).     Scope: an increase in responsibility that is broader and different than what has gone before. Three core features: bigger scale, bottom-line accountability, new required skills or knowledge.

                   (b).     Fix-it: fixing or stabilizing failing organizations or projects.                           

                   (c).     Scratch: building something from almost nothing; taking action under uncertainty.

                   (d).     Line to Staff: moving from line operation to a corporate staff role.

                   (e).     Project/task forces: discrete projects or temporary assignments done alone or as part of a team or task force with recognizable end points indicating success or failure.

                   (f).     Hardships: trials by fire, demanding situations sometimes resulting in great successes and sometimes feeling like                             setbacks or failures. (demotion, missed promotion, lousy job, personal trauma).

          (5).     Planning the assignments with respect to:

                   (a).     The learning goals to be derived.

                   (b).     The values and attitudes to be learned.

                   (c).     The performance goals and standards to be achieved as a result of the assignment.

          (6).     Debriefing the assignments, i.e., providing feedback to the staff member for developmental purposes keeping in mind the following:                            (a).     Performance outcomes.

                   (b).     The hierarchy of knowledge and skills required to perform the task.

                   (c).     The sequence of steps used to perform the task.

                   (d).     Special environmental conditions or concerns that had to be handled.

                   (e).     How efficiently and productively the person functioned throughout the assignment.

(B). THE PROGRAM’S STRUCTURE

          (1).     Knowing Oneself

There will always be a discrepancy between our self-image and how others perceive us. “Knowing oneself” entails being able to bridge that gap and to narrow it as much as possible. The successful Executive/Coach knows who he is, how he appears to others, what impact his style has on others. He is able to appropriately modify his behavior to achieve the results he wants. In particular, he is aware of his own developmental needs and ensures that they are satisfied. Since his feedback to Coachees in debriefing assignments is a major fulcrum on which the development of staff depends, all the more important is his self-understanding. To that end, we will utilize the following procedures:

                   (a).     A 360º feedback assessment at the beginning and at the end of the program.

                   (b).     Management assessments utilizing standard tests administered at the beginning of the program.

                   (c).     Personal one-on-one meetings with Managers/ Coaches both at the beginning of and throughout the program. These meetings will be devoted to reviewing the candidate’s own developmental process and progress.

                   (d).     Periodic team feedback (see below) to the Managers/ Coaches

                    “Knowing oneself” is also demonstrated in an Executive/Coach’s strategic vision of management, in being able to articulate, utilize and teach his philosophy of management. Therefore, another aspect of our program is:

                                     (e).     The development by each participant of a written and tested strategic vision of management.

          (2).     Knowing Others

We each have a philosophy of personality and of interpersonal behavior that is usually implicit and sometimes explicit. We use this philosophy to explain why people do what they do and, therefore, it molds how we respond to others. The danger is not in having one – we really don’t have a choice in the matter. Rather, it is in not being able to modify, change and expand it with experience. To be successful, the Executive/Manager has to be aware of his philosophy and its limitations and has to be willing to continually expand upon it. Accordingly, part of our program will be devoted to the Executives:

                   (a).     Making explicit their philosophies of personality and how they arrived at them.

                   (b).     Reviewing different personality theories, the object being to modify their thinking about people and people’s motivations.

                   (c).     Reviewing different theories of personal and professional development and their application to their work situations.

                   (d).     Utilizing this knowledge in discussing the developmental needs of their Direct Reports.

          (3).     Team Dynamics

The value in having a strong team behind you is that much more can be accomplished than otherwise. Each person on a strong team becomes more productive than otherwise. They share information more readily, they are more supportive of and helpful to each other, they suggest ideas that a person working alone or in a non-productive team would not have access to, they each know their role and what is expected of them. Executives/Coaches will learn about the value of teams through:

                   (a).     A review of team dynamics.

                   (b).     Discussion of how each is functioning as a team leader.            `       

(c).          Participating in their Executive/Coach team.

The Executive/Coach team is a crucial part of the training in that direct participation brings home the message more effectively than mere words. Being part of a team in which a person can trust expedites the learning and developmental process. In addition, our intent is for the Executive/Coach team to continue as a support group, a learning network, after the completion of training and, also, for its members to function as models and mentors for other Executives and Managers wanting to become Coaches.

          (4).     Task Assignments

The major vehicle for a Manager/Coach’s influence on the developmental process of personnel is the assignment and debriefing of tasks. Accordingly, the following issues will be dealt with in the program:

                   (a).     Determining the types of assignments that are available to be made.

                   (b).     Analyzing how they fit into the overall scheme of the mission of any particular Executive/Coach’s division.

                   (c).     Deciding on the needs of personnel.

                   (d).     Fitting the assignment to personnel.

                   (e).     Specifying the issues to be debriefed for Coachees.

                   (f).     Giving feedback to the Executive/Coach regarding how he debriefs any one Coachee.

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