MAN 6300 Module 4 Consulting Report Written Assignment Example

Keep the Speed, Restore the Voice: A Consulting Report and Twelve-Month Plan for a Contract Drug Manufacturer's Speaking-Up Problem

Student Name

Master of Science in Management, Thomas Edison State University

MAN-6300: Management Capstone

Mentor Name

Month Day, Year

Keep the Speed, Restore the Voice: A Consulting Report and Twelve-Month Plan for a Contract Drug Manufacturer's Speaking-Up Problem

Executive Summary

Since its 2024 acquisition, Millstone Pharma Services, a composite 480-employee maker of tablets and capsules for drug companies in central New Jersey, has improved productivity but lost much of its employees' willingness to raise quality concerns promptly. Only 41 percent of employees now say they can raise a concern without fear, deviations reported late have risen to 29 percent, and quality-staff turnover has reached 31 percent. The data analysis located the problem in quality functions and the night shift and linked it most strongly to supervisor behavior and to a reward system that favors output. This report recommends four changes: a balanced supervisor scorecard, coaching for supervisor openness, a retention plan for quality staff and a protected speak-up system. The plan costs about $544,000 in its first year, is expected to return about $502,000 in measurable savings, and reduces regulatory and client risks that are larger still. It is designed to keep the productivity gains of the acquisition.

Recommendation 1: Rebalance Measures and Rewards

Supervisors' bonuses are now based entirely on output. I recommend a scorecard weighted 40 percent on output, 30 percent on right-first-time batches and 30 percent on timely reporting, defined as the share of deviations entered within twenty-four hours. Timeliness, not the number of deviations, is rewarded, so the scorecard does not encourage hiding events. The color-coded shift league table should be replaced with a board that shows output and timely reporting side by side, and a monthly good-catch award should recognize employees whose reports prevented a problem. This change addresses the finding that employees read the reward system as the real statement of priorities.

Recommendation 2: Coach Supervisors in Openness

Supervisor openness had the strongest association with speaking up, and research shows that visible willingness to listen and act is a lever leaders control (Detert & Burris, 2007). All thirty-four supervisors and the site leadership team should complete a four-session program on responding to bad news, run by the training department with an outside facilitator. Each supervisor would then adopt one daily habit: closing the shift meeting by asking what worried people that day and recording one action taken in response. Edmondson (2019) describes such leader routines, including framing work as a learning problem and responding to concerns with appreciation, as the practical basis of psychological safety. Site leaders should hold monthly listening sessions on the night shift, where scores are lowest.

Recommendation 3: Retain Quality Staff

Quality functions had the lowest speaking-up score and the highest turnover. Three steps are recommended: a pay adjustment of 4 percent for quality staff to bring them to the regional market rate, a two-step career ladder from specialist to senior specialist with defined criteria, and two new night-shift quality leads, so that night operators have a quality colleague on site rather than a phone number. Stay interviews with every quality employee in the first quarter will identify other concerns before more people leave.

Recommendation 4: Protect the Speak-Up System

Stop-the-line authority should be restated by the site leader in person on every shift, written into each operator's job description and backed by a commitment that no one will be disciplined for a good-faith stop. A confidential reporting channel run by the parent company's compliance office should supplement, not replace, reporting through supervisors. Every concern raised through it should receive a written response within ten working days.

Legal and Ethical Implications

The recommendations support legal compliance as well as performance. FDA regulations require that deviations from written procedures be recorded and justified and that unexplained discrepancies be thoroughly investigated (21 C.F.R. § 211.100; 21 C.F.R. § 211.192). Late reporting makes thorough investigation harder, and it was the subject of the March 2026 inspection observation. New Jersey's Conscientious Employee Protection Act prohibits retaliation against employees who disclose or object to practices they reasonably believe violate the law (N.J. Stat. Ann. § 34:19-3), so any pattern of pressure on employees not to report quality problems would create legal exposure in addition to regulatory risk.

There is also an ethical dimension. The medicines Millstone makes are taken by patients who cannot inspect them, and clients rely on the site's honesty. Rewarding output in ways that discourage reporting shifts risk onto people who have no say in that choice. The recommended scorecard is designed so that the incentives point the same way as the site's obligations.

Financial Implications

First-year costs are estimated at about $544,000: $96,000 for supervisor training and facilitation, $213,000 for the quality-staff pay adjustment, $190,000 for two night-shift quality leads, $25,000 for recognition and $20,000 for a follow-up survey. Measurable savings are estimated at about $502,000. If quality-staff turnover falls from twenty-three departures a year to twelve, replacement costs fall by about $418,000, and if deviations return to about 120 a year, investigation labor falls by about $84,000. The plan therefore roughly pays for itself in its first year on these two measures alone.

The larger financial case is risk. A single mid-sized client represents several million dollars of annual revenue, and an FDA warning letter would affect every client relationship. The owner's growth plan for the new compression suites depends on a reputation for reliable quality. Against those exposures, the cost of the plan is small.

Human Capital Implications

The plan changes how supervisors are evaluated and paid, which may meet resistance from those who earned higher bonuses under the old system. A transition period in which supervisors receive the higher of their old-formula and new-formula bonus for two quarters will reduce that resistance. The pay adjustment and career ladder should improve retention, but they set an expectation that must be maintained in future budgets. Training time will take supervisors off the floor for about twelve hours each, scheduled across shifts to protect output.

Implementation Plan

The plan follows the sequence Kotter (2012) describes: creating urgency, building a guiding coalition, communicating a vision, removing obstacles, producing short-term wins and anchoring the change in the culture.

Two risks need active management. If the parent company sees the scorecard as weakening its output focus, the plan will stall; the presentation to the owner should therefore lead with the cost of quality failures and the commitment to keep effectiveness at or above 66 percent. If employees see the changes as slogans, trust will fall further; early, visible responses to concerns raised, and a published list of actions taken, are the best protection.

Conclusion

Millstone does not need to choose between the speed the owner wants and the quality culture that made it successful. The evidence shows that the speaking-up problem is concentrated, linked to supervisor behavior and rewards, and costly. Rebalancing incentives, coaching supervisors, retaining quality staff and protecting the speak-up system address those causes directly, support the site's legal and ethical obligations, roughly pay for themselves in a year, and can be carried out in twelve months with clear owners and measures. The final project will present these recommendations to the site's leadership.

References

21 C.F.R. § 211.192 (2025). Production record review. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-J/section-211.192

21 C.F.R. § 211.100 (2025). Written procedures; deviations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-F/section-211.100

Detert, J. R., & Burris, E. R. (2007). Leadership behavior and employee voice: Is the door really open? Academy of Management Journal, 50(4), 869-884. https://doi.org/10.5465/amj.2007.26279183

Edmondson, A. C. (2019). The fearless organization: Creating psychological safety in the workplace for learning, innovation, and growth. Wiley.

Kotter, J. P. (2012). Leading change. Harvard Business Review Press.

N.J. Stat. Ann. § 34:19-3 (2025). Retaliatory action prohibited.