Shortage Prevention and Mitigation Plans a Reality for Compliance

On June 18, 2024, the EMA issued templates for Shortage Prevention Plans (SPPs) and Mitigation Plans (SMPs). Marketing authorization holders (MAHs) in the European Union/European Economic Area are encouraged to create SPPs to minimize the risk of medicinal shortages. SPPs are already obligatory under Regulation 2022/123 for drugs listed in the list of critical medicines for that particular crisis, and the US has similar guidance.

Shortage Prevention Plans help to identify and manage potential risks in the supply chain and include information on the MAH, the supply and manufacturing chain, key data on stock, sales, consumption, and manufacturing, and an analysis of the history of supply issues. A SPP should be in place for each medicinal product marketed by the MAH. The minimum requirements for the SPP state that MAHs should analyze and evaluate weaknesses in the supply chain. The robustness of shortage prevention measures is to be evaluated. MAHs are obliged to assess the risks of supply interruptions for patients. A medicine shortage risk register should be developed to identify clinically significant products based on therapeutic use and availability of substitutes. Using available information, such as root cause analysis of shortages, the MAH must determine whether corrective and preventive actions or revalidation are needed nationally and internationally. Furthermore, MAHs should maintain minimum stock levels at national levels. Measures to prevent drug shortages should be reviewed regularly.

Shortage Mitigation Plans are designed to eliminate potential or actual drug shortages and minimize the impact on patients. The minimum requirements for the SMPs include procedures for dealing with shortages, from identification to resolution. These procedures should include measures to reduce the shortage’s impact, notification to regulatory authorities, and follow-up actions. MAHs should define roles, responsibilities, and escalation processes and maintain records of root causes and mitigation measures after resolving shortages.

Both should be readily available for submission upon request and can be subject to inspection during GMP and/or GDP inspections or inspections of MAHs. Thus, they should be living documents in the quality system together with the SMF, contamination control strategies, APQRs, and other similar apex documents.

Parental Leave

When I had my kids I was lucky to be able to take a week or two, and it certainly wasn’t easy coming back. As such I’m really invested in making sure my team gets the opportunity to have more breathing room around parental leave than I did. Here’s my checklist of activities.

Recommendation	Description
Plan early	As soon as you are notified of the upcoming leave, start discussing transition plans, coverage needs, and expectations.
Create a transition plan	Work with the employee to document key responsibilities, ongoing projects, contacts, and critical information.
Be supportive	Recognize this as an important life event and avoid making employees feel guilty about taking leave.
Maintain appropriate contact	Establish expectations upfront for communication during leave.
Plan for re-entry	Schedule a meeting before the employee returns to bring them up to speed on changes.
Be flexible upon return	Consider gradual return options and be open to flexible work arrangements.
Focus on outputs	Trust that the employee can still perform at a high level, even if their work style changes.
Provide mentoring support	Connect returning parents with other employees who have successfully navigated parental leave.
Review compensation fairly	Ensure taking leave doesn’t unfairly impact compensation or advancement opportunities.
Use leave as an opportunity	Identify ways to improve processes or develop other team members’ skills.
Communicate effectively	Be transparent about leave plans and delegate responsibilities clearly.
Trust and empower	Create growth opportunities for team members by delegating responsibilities.

Actions for Parental Leave

Thinking About the High Performers

I am blessed to have inherited a lot of high performers from my predecessor, who built and sustained a highly functioning team, often amid chaos.

I think about what that means to my team a lot. Being a bunch of high performers, they tend to get:

Stressful projects and goals: They often receive a lot of complex and risky projects and goals.
Meeting mania: Because my team is viewed as an essential part of the work (and they are) and can solve even the thorniest issues, their days are filled with back-to-back meetings.
Return-to-office pressure: Because they are “high profile,” my local team members are expected to work more from the plant, resulting in less flexibility. There are many good reasons for this, but that doesn’t make it more popular.

As I move through my 2nd quarter, here are the activities I am working to implement.

Establish a simple weekly team rhythm that drives intensity, not pressure. This is going to take a lot of effort with my peer teams. We need to build a rhythm where we know (to a much higher detail) the types of work we do. I want to move more to a model where we do prioritization on Monday, including defining projects, managing change controls, etc.; problem-solving midweek and a time we do a lot of execution (though frankly, that also happens on the weekend); and Friday is to review completed work, share feedback, and align on next steps. No matter what, we need to create a standardized calendar.

Measure the team’s motivation. As I get close to my 5-month mark, I will be asking the following questions:

What are teammates excited about working on in the second half of the year?
What might be causing them anxiety or pressure?
What habits does the team want to improve?
What are some specific ideas for improving those habits?
What did we do really well last quarter that we should maintain?

Continue to prioritize teaching. I will be scheduling a quarterly skill-check meeting with each of the team. During this conversation, I will help the individual reflect on their current skill goals and pick a new one if they don’t yet have any or have hit them all. We put a lot of work into this during my first quarter, and it is critical to continue to grow here.

Practice Joy. Practicing joy at work is important to maintaining a positive work environment and improving overall job satisfaction.

Cultivate gratitude: Start each day by acknowledging something you’re grateful for at work.
Celebrate small wins: Recognize and appreciate your accomplishments, no matter how small. This can boost your motivation and create a sense of progress.
Find purpose in your work: Connect your daily tasks to the larger goals of your organization or to your personal values. Understanding how your work contributes to a greater purpose can increase job satisfaction.
Find humor in daily situations: Look for opportunities to laugh and share light moments with your colleagues. Humor can help reduce stress and create a more positive work environment.
Practice self-care: Prioritize your physical and mental health by getting enough sleep, eating well, and exercising regularly. When you feel good, it’s easier to experience joy at work.

Preventive Maintenance and Calibration

I find that folks often confuse preventive maintenance and calibration. While both processes contribute to overall asset reliability and performance, preventive maintenance focuses on maintaining general functionality, while calibration ensures measurement accuracy. In many cases, calibration can be considered a specialized form of preventive maintenance for measuring instruments. Some equipment may require preventive maintenance and calibration to ensure optimal performance and accuracy. Understanding the difference can be vital to the asset lifecycle. Misunderstanding can lead to poor asset control (and maybe an audit finding or two).

Preventive Maintenance

Preventive maintenance (PM) is a proactive approach to equipment and asset management involving regularly scheduled inspections, cleaning, lubrication, adjustments, repairs, and replacement parts. The goal is to prevent unexpected breakdowns and extend the lifespan of assets.

Purpose

Prevent equipment failures before they occur
Extend asset lifespan
Reduce unplanned downtime
Improve overall equipment reliability and efficiency

Types

Time-Based Maintenance (TBM): This involves performing maintenance tasks at fixed time intervals, regardless of the asset’s condition. For example, servicing equipment every 3 months or annually.
Usage-Based Maintenance: Maintenance is scheduled based on an asset’s actual utilization or operational hours.
Condition-Based Maintenance (CBM): This approach involves monitoring the actual condition of assets to determine when maintenance should be performed.
Predictive Maintenance (PdM): This uses data analysis tools and techniques to predict when an asset will likely fail and should be maintained.
Failure-finding maintenance (FFM) detects hidden failures, typically in protective devices and backup systems.
Risk-Based Maintenance (RBM): Maintenance activities are prioritized based on the risk assessment of equipment downtime and its impact.
Prescriptive Maintenance: This predicts when failure will occur, analyzes why, and determines different options to mitigate risks.
Meter-Based Maintenance: Similar to usage-based maintenance, this type schedules tasks based on equipment meter readings.

These different types of preventive maintenance can be used individually or in combination, depending on the organization’s specific needs, the criticality of the assets, and the available resources. The goal is to prevent unexpected breakdowns, extend equipment life, and optimize maintenance costs

Key components

Regular inspections
Cleaning and lubrication
Adjustments and calibrations
Minor repairs and parts replacements

Benefits

Reduced unexpected breakdowns and associated costs
Improved equipment reliability and performance
Extended asset lifespan
Enhanced safety for operators and employees
Better compliance with warranties and regulations
Increased productivity due to reduced downtime

Implementation

Identify critical assets requiring PM
Develop maintenance schedules based on manufacturer recommendations and historical data.
Use preventive maintenance software or CMMS (Computerized Maintenance Management System) to manage schedules and work orders.
Train maintenance staff on PM procedures
Regularly review and optimize the PM program.

Calibration

Calibration is the act or process of comparing an instrument’s measurements to be calibrated against a traceable reference standard of known accuracy. It involves establishing a relationship between the measurement values of the device under test and those of the calibration standard.

Purpose

To ensure the accuracy and precision of measuring instruments
To determine and minimize measurement errors
To maintain the reliability of measurement results

Process:

Comparing the device under test with a calibration standard
Documenting the comparison results
Adjusting the device if necessary (although, strictly speaking, adjustment is not part of the formal definition of calibration)

Key components

Traceability: Calibration standards should be traceable through an unbroken chain of comparisons to national or international standards, each with stated uncertainties.
Uncertainty: Calibration includes the concept of measurement uncertainty, which defines the range of probable values of the measurand and indicates the “goodness” of the calibration process.
Applications: Calibration is used in various fields, including metrology, engineering, science, and industry. It applies to a wide range of measuring instruments, from simple thermometers to complex electronic devices.
Frequency: Instruments may require calibration for various reasons, including:

When new or after repairs
After a specified time period or usage
Before critical measurements
After exposure to conditions that might affect accuracy

Documentation: Calibration procedures are typically documented in specific test methods, capturing all the steps needed to perform a successful calibration.

Aspect	Preventive Maintenance	Calibration
Purpose	Prevent equipment failures and extend asset lifespan	Ensure accuracy and precision of measuring instruments
Scope	Wide range of activities to keep equipment in good working condition	Focused on measurement accuracy of instruments and devices
Frequency	Regular schedule based on time intervals or usage	Specific intervals, after repairs, or when accuracy is critical
Outcome	Improved reliability, reduced downtime, extended asset life	Accurate and reliable measurements within acceptable tolerances
Process	Cleaning, lubrication, parts replacement, visual inspections	Comparing readings to known standards, making adjustments
Applicability	Wide range of equipment and machinery	Specific to measuring instruments and devices

comparison of the key differences between preventive maintenance and calibration

Pay Attention to the Psychological Contract

A psychological contract refers to the unwritten, intangible set of expectations, beliefs, and obligations that define the relationship between an employer and an employee. Unlike a formal employment contract, which is legally binding and outlines specific duties, responsibilities, and compensation, a psychological contract encompasses the informal and often unspoken aspects of the employment relationship.

Key Characteristics of a Psychological Contract

Unwritten and Intangible: Psychological contracts are not documented formally. They are based on mutual perceptions and understandings that develop through interactions and experiences over time.
Mutual Expectations: These contracts involve what each party expects from the other. For example, an employee might expect job security, opportunities for growth, and fair treatment, while an employer might expect loyalty, hard work, and a willingness to go above and beyond.
Dynamic and Evolving: The terms of a psychological contract can change over time as the needs and circumstances of both the employee and employer evolve. What is considered fair and balanced at one stage of an employee’s career might change as their personal and professional priorities shift.
Relational and Transactional Elements: Psychological contracts can be categorized into relational and transactional. Relational contracts are long-term and based on mutual trust and loyalty, while transactional contracts are short-term and focus on specific exchanges of labor for rewards.

Importance of Psychological Contracts

Employee Engagement and Motivation: A well-balanced psychological contract can increase employee engagement, motivation, and job satisfaction. Employees who feel their expectations are being met are more likely to be committed to their organization and perform better.
Organizational Performance: Organizations that manage psychological contracts effectively can benefit from improved performance and lower turnover rates. Employees who perceive their psychological contract as fair are likelier to stay with the company and contribute positively to its goals.
Trust and Fairness: The psychological contract is crucial for building trust between employees and employers. When employees feel that their employer is keeping its informal promises, it fosters a sense of fairness and mutual respect.

Breach of Psychological Contracts

A breach occurs when one party perceives that the other has failed to fulfill its obligations. This can lead to feelings of betrayal, decreased job satisfaction, and reduced organizational commitment. Common consequences of a breached psychological contract include increased turnover, lower productivity, and higher levels of employee disengagement.

Examples of Psychological Contracts

Promotion Expectations: An employee might be verbally promised a promotion after completing specific training. If this promotion does not materialize, the employee may feel that the psychological contract has been breached.
Work-Life Balance: An organization might have an unwritten rule that employees can leave early on Fridays. Employees might feel that their psychological contract has been violated if a new manager enforces strict hours.
Job Security: Employees might expect job security in exchange for their loyalty and hard work. If the company undergoes layoffs without clear communication, it can lead to a breach of the psychological contract.

Managing Psychological Contracts

Communicate Clearly: Regular and transparent communication helps align expectations and reduces misunderstandings.
Foster Trust: Building a culture of trust and fairness can help maintain a positive psychological contract.
Adapt to Changes: Recognize that employees’ needs and expectations change over time and be willing to adapt accordingly.

Yes, psychological contracts change over time, and there are several ways this can occur:

Organizational changes: Major organizational shifts, such as restructuring, mergers, or leadership changes, can alter the implicit expectations and obligations between employees and employers. For example, a company that previously emphasized job security may shift towards a more flexible workforce, changing the psychological contract around long-term employment.
Societal and economic changes: Broader societal trends and economic conditions can influence psychological contracts. The COVID-19 pandemic, for instance, dramatically shifted expectations around remote work and work-life balance for many employees and employers.
Career progression: As employees advance, their expectations and perceived obligations often evolve. An entry-level employee might prioritize learning opportunities, while a more experienced worker may expect greater autonomy and decision-making power.
Generational differences: Different generations often have varying expectations about work. Younger generations may emphasize work-life balance and purpose-driven work more than older generations.
Technological advancements: The rapid pace of technological change can alter how work is performed and what skills are valued, shifting the psychological contract.
Personal life changes: Major life events for employees (e.g., starting a family or approaching retirement) can change their priorities and expectations from work.
Ongoing experiences and interactions: Day-to-day experiences and interactions between employees and employers continuously shape and refine the psychological contract.
Explicit renegotiation: In some cases, employers and employees may openly discuss and revise their mutual expectations, especially during performance reviews or when job roles change significantly.

It’s important to note that these changes in psychological contracts can sometimes lead to perceived breaches if not properly managed or communicated. Organizations and employees need to be aware of these potential shifts and work to maintain alignment in their mutual expectations over time. Regular communication, transparency, and flexibility are crucial to adapting psychological contracts as circumstances change.

Psychological contracts are under constant assault in most workplaces. Just look at all the tension around returning to work, quitting quietly, and whatever the new term de-jour is. We have entered an era in which continuous reinvention is the only way to manage continuous turbulence. This means that, when it comes to the psychological contract, we are (inadvertently) lying to our employees everywhere. Gone are the days when “you support this one-time transformation, and things will return to normal for a few years.” Now is the time for honest dialogue and explicit re-negotiation. We must allocate some of our time and resources to perpetual reinvention to survive and thrive in the perpetually turbulent world. That is the new normal. And psychological contracts are under a lot of tension. Plan to deal with that.