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Oct 27, 2016

5 Nightmares that Haunt Quality Managers

Are corporate zombies, phantom projects
or life-draining QMS processes
keeping you awake at night?


by David R. Butcher

Marketing Communications

MasterControl



There are a number of spooky scenarios that quality managers face in their jobs, from unsupported initiatives and disengaged team members, to ineffective change management and inefficient QMS processes.

The five nightmares below are enough to keep any quality manager up at night – or to make them scream in terror!


1) Ghost of a Chance with Invisible Projects


Solution: Ensure support for quality initiatives with executive sponsors.

A lack of resources and support for a given project is often tied to a failure of getting executive buy-in. Make no bones about it, failure to have the necessary support from senior leadership can significantly impede a quality project’s success. In fact, according to the Project Management Institute (PMI), an executive sponsor’s active engagement is actually the top driver of project and program success.

For this reason, it is important that quality managers engage executive leadership and ensure their commitment to meaningful support of the quality efforts.

Effective executive sponsors have thorough knowledge of a project and how it connects to business strategy,” PMI says in its 2016 Pulse of the Profession report. “And owing to their position and experience, they have the necessary skills and authority to clear roadblocks, the confidence to make quick and effective decisions, and the influence to champion the project with senior management and position it as a top priority.

When members of the quality team and the rest of the organization see that senior leadership is committed to supporting quality, they are more likely to achieve success in their projects and work.

“With actively engaged executive sponsors, organizations can bridge the communications gap between influencers and implementers to significantly increase collaboration and support, boost project success rates and reduce risk,” according to PMI.




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2) Scared to Death of Change


Solution: Minimize fear of organizational change through effective change management.

Whether it’s implementing enterprise quality management software (EQMS) or undertaking ISO 9001:2015 certification, most quality initiatives involve change. Yet when it comes to organizational change, failure continues to be more common than success, according to McKinsey, HBR, PWC, Towers Watson and others in recent years.

Change can be intimidating and managing it arduous, which is why people are often terrified of it. Yet when quality leaders expect change and ensure that employees and executive leadership do as well, they can transition everyone involved into the new state more smoothly, with fewer pains and with more people open to accepting change.

Quality leaders must understand the change management process and how it helps with the successful implementation of a quality management initiative. Every organization’s change management process will vary, but the successful ones at least include: 1) identifying the key objectives of the initiative; 2) developing a team to steer the process; 3) communicating the change to everyone who will be affected; 4) engaging employees and welcoming their input; and 5) providing adequate training to build knowledge about the change and required competencies.

Ultimately, the best way to manage change is to always be prepared for it. Quality managers should understand that it’s nearly impossible to anticipate everything at the start of the project and, with that in mind, should foster a culture of perpetual change preparedness.

3) Managing the Walking Dead


Solution: Engage and retain talented quality management professionals.

Disengaged workers tend to be slow, uncommunicative, easily distracted, lacking enthusiasm and in a constant state of shuffling through the day showing few signs of life. Sound familiar? According to 2016 findings by Gallup, only 32 percent of employees in the U.S. are engaged – meaning “they are involved in, enthusiastic about and committed to their work and workplace.”

In a recent survey of more than 1,000 professionals in life sciences in the U.S., Europe and Asia Pacific, ProClinical found that 67 percent of respondents are engaged. Medical device companies have the highest level of engagement (71 percent) while those working for contract research organizations are the least engaged (62 percent).

The staffing company’s 2016 Employee Engagement Report also says that 43 percent of employers aren’t even surveying workers to understand their engagement level. This is a problem for quality managers in the life sciences, as they risk losing their best and brightest talent: disengaged employees were found to be twice as likely to leave their employers.

Respondents were asked a series of questions about commitment, caring, trust, recognition and job satisfaction. The most important factors in keeping life science employees engaged: 1) working in a role that is challenging and aligned with their skills; 2) career development opportunities; and 3) receiving recognition.

The findings underscore the importance of listening to employees and providing internal opportunities for career growth and regular recognition when quality managers in life sciences try to build and retain successful teams.

4) Feeding Braaains


Solution: Invest in ongoing employee training and professional development.

As noted above, job skills and professional development are important factors in employee engagement and talent retention. For these reasons, it is important that quality managers and their staff continue to upskill – through classroom education, online training, seminars, workshops, conferences, professional certifications, mentorships, etc. – with employer support on an ongoing basis.

Investing in training and development programs can improve employees’ job satisfaction, performance and security in their positions by enhancing their value to the company. Some employers may be reluctant to invest more in training programs rather than into core business functions. However, many are realizing that the initial costs of training and development may seem high, but they are a long-term investment in the development of their talent and their business.

“Increasingly, life science employers stress employee development as a key strategy for securing and keeping valuable talent. Many recognize that they can both increase productivity and reduce turnover by providing career growth opportunities for employees, and allowing them to explore career paths, create development plans and otherwise build their resumes,” according to the Coalition of State Bioscience Institutes’ 2016 Life Sciences Workforce Trends report. “In addition, as technologies and corporate environments evolve, employees must also develop new skills. Ongoing training and development are essential to keep employees’ technical and business skills relevant and help companies attract the best talent.”

5) Blood-Sucking Processes


Solution: Automate with robust QMS tools to improve efficiency.

Many organizations still rely on manual, paper-based systems for managing quality processes and documents. These systems tend to drag down operational efficiency and hinder companies’ ability to get products to market quickly and safely. There’s incomplete or outdated documentation, duplication of effort and many other workflow inefficiencies that can suck the life from a QMS.

For instance, in 2013 survey findings from Harris Interactive, 83 percent of knowledge workers said they lose or waste time due to document collaboration issues on a daily basis. Common issues include: wasting time looking for files; confusion about the right version of a document; manually merging changes from multiple contributors; and working on the wrong or outdated version. These inefficiencies bleed companies dry, costly as they are in terms of low productivity, poor decision making, decreased morale, damaged reputation and even lost business.

A robust electronic QMS can help reduce the blood-letting by giving regulated companies the infrastructure and automated tools needed to bring all documents- and forms-based quality processes together within a single, secure platform. An effective EQMS can improve efficiency related to quality processes critical in compliance, reducing waste and enhancing visibility and control.

For quality managers and their teams, this means automating tasks and workflow, improving communication and collaboration and, ultimately, streamlining critical processes to significantly cut down throughput processes and cycle times. By automating their QMS, quality managers can empower employees to focus less on managing processes/documents and more on adding value.


What other nightmares terrify quality managers? Are blood-sucking processes draining the life from your job? Let us know below!


David Butcher has been writing about business and technology trends in the industrial B2B space for more than a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.







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White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
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White Paper: Six Corporate Oversights of Quality and Compliance Issues in Pharmaceutical Environments
Analyst Report: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)