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.

Cleaning Solution and a Disinfectant Solution

To the average person on the floor, there are just things to clean with. However, cleaning and sanitization are very different, and it’s important to recognize this and ensure folks are properly educated. I can’t count how many audits I’ve had where this became a tripping point.

The primary difference between a cleaning solution and a disinfectant solution lies in their purposes and the outcomes they achieve.

Cleaning Solutions

Purpose: Cleaning solutions are designed to remove dirt, dust, grime, and impurities from surfaces. This process involves using soap, detergents, or other cleaning agents combined with water and physical action (e.g., scrubbing) to lift and wash away contaminants.

Effectiveness: Cleaning physically removes germs from surfaces but does not necessarily kill them. It reduces the number of germs and prepares the surface for further treatment, such as sanitizing or disinfecting.

Examples: Common cleaning agents include all-purpose cleaners, dish soap, and glass cleaners.

Disinfectant Solutions

Purpose: Disinfectant solutions are specifically formulated to kill or inactivate harmful microorganisms on surfaces, including bacteria and viruses. They contain chemical agents that are effective against a wide range of pathogens.

Effectiveness: When used correctly, disinfectants are designed to kill nearly 100% of the germs listed on their labels. They are regulated by the Environmental Protection Agency (EPA) and must meet stringent efficacy standards.

Examples: Common disinfectants include bleach solutions, alcohol-based solutions, and products containing quaternary ammonium compounds (QUATS).

Here is a table comparing the key differences between cleaning solutions and disinfectant solutions:

Aspect	Cleaning Solutions	Disinfectant Solutions
Purpose	Remove dirt, dust, grime, and impurities	Kill or inactivate harmful microorganisms
Effectiveness	Physically removes germs but does not necessarily kill them	Kills nearly 100% of germs listed on their labels when used correctly
Examples	All-purpose cleaners, dish soap, glass cleaners	Bleach solutions, alcohol-based solutions, QUATS
Function	Reduces the number of germs	Kills or inactivates germs
Usage	First step in the cleaning process	Applied after cleaning to kill remaining germs
Regulation	Not always regulated by the EPA unless they have sanitizing or disinfecting claims	Must be registered with the EPA and meet specific efficacy standards
Contact Time	Not applicable	Requires specific contact time (usually 5-10 minutes)
Safety	Generally safer, fewer precautions needed	May require precautions such as gloves or ventilation
Impact on Equipment	Less likely to cause wear and tear on equipment	Can be harsh on surfaces and equipment, potentially causing damage over time

Comparison of the key differences between cleaning solutions and disinfectant solutions

Method Qualification and Validation

The terms “method qualification” and “method validation” are often used in the context of analytical procedures in the pharmaceutical and biotechnology industries. While related, they serve different purposes and are applied at different stages of method development. Here is a detailed comparison of the two:

Method Qualification

Definition

Method qualification demonstrates that an analytical method is suitable for its intended use during the early stages of development. It involves preliminary testing to ensure the method can produce reliable and reproducible results for the specific application.

Purpose

Early Development: This is typically performed during the early phases of drug development (e.g., preclinical and Phase I clinical trials) to assess the method’s feasibility.
Optimization: Helps in optimizing the method to ensure it meets the necessary performance criteria before full validation.
Feasibility Studies: Often referred to as feasibility or pre-validation studies, method qualification helps understand the method’s performance characteristics and establish preliminary acceptance criteria.

Characteristics

Flexibility: The method can still be modified and optimized based on the results obtained during qualification.
Parameters: This evaluation method evaluates fewer parameters than validation, focusing on key performance indicators like specificity, linearity, accuracy, and precision.
Voluntary: This is not always required by regulatory authorities, but it is a good practice to ensure the method is on the right track for future validation.

Example

A company developing a new drug might perform method qualification to ensure that their analytical method can accurately measure the drug’s concentration in biological samples before moving on to more rigorous validation studies.

Method Validation

Definition

Method validation proves that an analytical method is suitable for its intended purpose and can consistently produce reliable and reproducible results under specified conditions. It is a regulatory requirement for methods used to test drug substances and products.

Purpose

Regulatory Compliance: Required by regulatory authorities (e.g., FDA, EMA) for methods used in quality control and release testing of pharmaceutical products.
Late Development: This is typically performed during the later stages of drug development (e.g., Phase III clinical trials, and commercial production) when the method is fully developed and optimized.
Consistency: Ensures that the method produces consistent results over time and across different laboratories.

Characteristics

Rigidity: The method must be fully developed and optimized before validation. Any changes to the method after validation would require re-validation.
Comprehensive: Involves a thorough evaluation of multiple parameters as defined by guidelines such as ICH Q2(R1), including accuracy, precision, specificity, linearity, range, limit of detection (LOD), limit of quantification (LOQ), robustness, and ruggedness.
Mandatory: Required by regulatory authorities to ensure the quality, reliability, and consistency of analytical results.

Example

Before a pharmaceutical company can market a new drug, it must validate its analytical methods to demonstrate that they can reliably measure the drug’s potency, purity, and stability according to regulatory standards.

Key Differences

Aspect	Method Qualification	Method Validation
Stage of Development	Early stages (pre-clinical, Phase I)	Later stages (Phase III, commercial production)
Purpose	Feasibility and optimization	Regulatory compliance and consistency
Flexibility	Method can be modified	Method must be fully developed and optimized
Parameters Evaluated	Fewer, key performance indicators	Comprehensive, as per regulatory guidelines
Regulatory Requirement	Voluntary, good practice	Mandatory

In summary, method qualification is an early-stage activity aimed at ensuring that an analytical method is on the right path to becoming reliable and reproducible, while method validation is a more rigorous, comprehensive process required to demonstrate that the method meets all regulatory requirements for its intended use.

Practicing Humbleness

My greatest weakness is my poor track record of practicing humbleness. Balancing humility with assertiveness in professional life is essential for effective leadership and personal growth. It is critical to being an expert. So here are the things I remind myself of and practice as part of my mindfulness.

Acknowledge your limitations and knowledge gaps

Be open about areas where you still have more to learn
Admit when you don’t know something or are uncertain
Recognize that expertise in one area doesn’t make you an expert in everything

Remain open to learning from others

Listen attentively to different perspectives and ideas
Be willing to change your views based on new information
Seek out opportunities to expand your knowledge

Give credit to others

Recognize the contributions and insights of colleagues and mentors
Share credit for successes and accomplishments
Use “we” instead of “I” when discussing team achievements

Practice gratitude

Express appreciation for opportunities you’ve had to develop expertise
Thank those who have supported your growth and learning
Be grateful for chances to share your knowledge with others

Stay curious and ask questions

Maintain a learner’s mindset, even as an expert
Ask thoughtful questions to deepen your understanding
Be open to new ideas and approaches in your field

Focus on serving others with your expertise

Use your knowledge to help and empower others
Prioritize making a positive impact over personal recognition
Share your expertise generously without expectation of reward

Reflect on your journey and growth

Remember the challenges you faced in developing your expertise
Consider how much more there is still to learn in your field
Appreciate the ongoing nature of learning and development

Accept and learn from criticism and feedback

Be open to constructive criticism of your work
Use feedback as an opportunity for improvement
Avoid becoming defensive when your ideas are challenged

By consistently practicing these behaviors, we can maintain humility while confidently sharing our expertise. This approach allows us to continue growing professionally while fostering positive relationships and respect from colleagues and peers.