Module - 5

TOTAL PRODUCTIVE MAINTENANCE

a) Total Productive Maintenance (TPM):
Definition, Types of Maintenance, Steps in introduction of TPM in an
organization,Pillars of TPM – 5S, Jishu Hozen, Quality Maintenance,
Planned Maintenance.
b) Quality by Design (QbD): Definition, Key components of QbD, Role of
QbD in Pharmaceutical Industry, Benefits and Challenges of QbD.
c) Environmental Management Systems (EMS): Definition, Basic EMS,
EMS under ISO 14001, Costs and Benefits of EMS.
Maintenance Engineering is the discipline and profession of applying
engineering concepts for the optimization of equipment, procedures, and
departmental budgets to achieve better maintainability, reliability, and
availability of equipment.
 8 Pillers of TQM
Focused Improvement (Kobetsu Kaizen): Small, cross-functional teams work together to
proactively eliminate recurring losses and inefficiencies, ensuring continuous
improvement.
Autonomous Maintenance (Jishuken): Empowers operators to perform daily tasks like
cleaning, lubrication, and inspection, fostering ownership of their equipment.
Planned Maintenance: A structured approach scheduling preventive and predictive
actions based on machine data to avoid unplanned downtime.
Quality Maintenance (Hinshitsu Kaizen): Focuses on managing equipment to ensure it
produces defect-free products, detecting errors to reduce the Cost of Poor Quality
(COPQ).
Early Equipment Management: Uses experience from current machinery to design new,
more reliable, and maintainable equipment for future production.
Training and Education: Enhances the technical skills and knowledge of operators,
maintenance teams, and managers to support TPM goals.
Administrative & Office TPM: Extends TPM principles beyond the shop floor,
streamlining support functions like procurement and scheduling for better efficiency.
Safety, Health, and Environment: Aims to create a safe, healthy workplace, targeting
zero accidents and zero fires to ensure a sustainable working environment.
• Benefits of Total Productive Maintenance
• Minimal malfunctions of equipment
• Elimination of unforeseen downtime
• Enhanced performance and output
• Lower operating costs
• Cleaner and healthier work environment
• Improved workplace safety due to stricter adherence to safety
regulations
• Intensified skill development
• Greater employee empowerment
• Higher collaboration and sharing of knowledge between departments
and teams
• Reduced risks of accidents
• Better compliance with environmental laws and guidelines
• Increased satisfaction among all stakeholders
Quality by Design (QbD): Definition, Key components of QbD, Role of QbD
in Pharmaceutical Industry, Benefits and Challenges of QbD
Quality by Design (QbD) is a systematic, science-based pharmaceutical
development approach that builds quality into products from the start,
rather than relying on final testing. It aims to ensure consistent,
high-quality drug products by understanding and controlling critical
material attributes and process parameters. Key components
include Target Product Profile (QTPP), Critical Quality Attributes (CQAs),
and Design Space.
Key Components of QbD
Quality Target Product Profile (QTPP): Identifies the target, quality, safety,
and efficacy of the drug product.
Critical Quality Attributes (CQAs): Physical, chemical, or biological properties
of the product that must be within appropriate limits.
Critical Material Attributes (CMAs): Raw material properties influencing
product quality.
Critical Process Parameters (CPPs): Process parameters whose variability
affects product quality.
Design Space (DS): The multidimensional combination of input variables (e.g.,
material attributes) and process parameters that provide assurance of
quality.
Control Strategy: A planned set of controls derived from current product and
process understanding to ensure performance
Role of QbD in the Pharmaceutical Industry
Proactive Quality Assurance: Shifts focus from testing for quality at the end
to creating it during the development phase.
Process Understanding: Uses tools like Design of Experiments (DoE), risk
assessment, and Process Analytical Technology (PAT) to understand the
relationship between process, materials, and product.
Regulatory Flexibility: Allows for manufacturing improvements within the
approved Design Space without needing new regulatory approval.
Risk Management: Identifies potential issues early, reducing failures and
increasing product reliability.
Benefits of QbD
Reduced Batch Failures: Minimizes deviations, leading to better yield.
Increased Efficiency: Streamlines development and manufacturing,
lowering costs.
Real-time Release Testing (RTRT): Enables faster product release by
enabling in-process testing rather than relying on final inspection.
Continuous Improvement: Facilitates ongoing process optimization
Challenges of QbD
Implementation Resistance: Resistance to changing from traditional,
familiar methods to new, complex systems.
Resource Intensive: Requires significant upfront investment in
technology, training, and development time.
Complex Regulatory Hurdles: Although designed to streamline,
implementing and managing the documentation for a full QbD filing can
be initially challenging
Definition of an EMS
An EMS is a set of processes and practices that enable an organization
to reduce its environmental impacts and increase its operating
efficiency. It is not a checklist for compliance, but a comprehensive,
organization-wide framework that incorporates environmental
considerations into daily decision-making.
Basic Components of an EMS
A functional EMS generally follows the Plan-Do-Check-Act (PDCA) model,
which includes:
Environmental Policy: Top management commits to environmental
improvement.
Planning: Identifying environmental aspects (e.g., waste, emissions) and
legal requirements.
Implementation: Developing processes to meet environmental targets,
including training.
Checking/Evaluation: Monitoring and measuring operations against
environmental objectives.
Management Review: Reviewing results to drive continual improvement.
EMS under ISO 14001
ISO 14001 is the world’s most recognized standard for EMS, providing a
framework for certifying that an organization has appropriate
environmental practices in place.
Structure: It relies on voluntary initiatives, encouraging organizations to
identify aspects of their activities that have significant environmental
impacts.
Integration: It can be integrated with other management systems, such as
ISO 9001 (Quality) or ISO 45001 (Health & Safety).
Certification: Certification requires a rigorous audit by an external body to
ensure compliance.
Costs and Benefits of an EMS
Reduced Negative Impacts: Minimizes environmental footprint.
Regulatory Compliance: Reduces risks of fines and legal penalties.
Cost Savings: Lower costs through energy efficiency and reduced waste
management expenses.
Improved Reputation: Boosts credibility with customers and stakeholders.
Employee Engagement: Increases staff awareness and morale.
Costs:
Implementation Costs: Financial investment in training, consultants, and
new technologies.
Resource Allocation: Time investment for management and staff to
maintain the system.