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Central Sterilization Department Remodel

Quality Management Plan


With the implementation of a new quality management plan for the Central Sterilization Department Remodel project, it is expected that a renovated department will meet and exceed industry standards. This includes efficiency, safety, compliance with statutory provisions, and satisfactory patient care quality.

Quality Standards

Compliance with Regulatory Standards: Follow all relevant regulations and standards, such as those established by the medical conformity boards, regulatory bureau, and accreditation association.

Industry Best Practices: Use standardized best practices in the design and layout of sterilization departments, selection and use of equipment technologies, optimization of staff workflows, and employee training practices.

Patient Safety: This process will enable the community to prioritize patients’ safety by employing advanced sterilization equipment, strict training regimes, and implementing infection control guidelines.

Equipment Reliability: Use equipment and technology renowned for reliability, durability, and continual performance support towards minimization of downtime and interruption-free sterilization activities (World Health Organization, 2021).

Continuous Improvement: Create feedback loops for ongoing monitoring, controlling, checking, and adjusting sterilization processes, workflows that support IPO cycle stages, and staff training and development programs.


Sterilization Efficiency: Sterilization time before and after remodeling activities can be measured to gauge the efficiency’s impact (World Health Organization, 2021).

Compliance Rate: Make sure you track protocols and standards to satisfy the regulatory bodies.

Patient Satisfaction: The other way is to get feedback from patients and healthcare professionals involved in sterilizing the equipment regarding their experience using sterilized products.

Equipment Downtime: Monitor and reduce prolonged equipment shutdown to ensure its uninterrupted sterilization system.

Training Completion Rate: Measure the percentage of employees who successfully enroll in mandatory training programs, which should make them remain competitive regarding new processes and technologies being put into place.

Problem Reporting and Corrective Action Process

Formulate a formal procedure of quality reporting that will tackle standard omissions, equipment failures, and security issues.

Appoint a Quality Assurance Officer to ensure that the issues reporting process is rightly followed and appropriate corrective actions are started (World Health Organization, 2021).

Design and implement a corrective action plan, including root cause analysis and corrections made when the problem occurs in case different issues persist, among other preventative procedures.

Supplier Quality and Control

Assess suppliers based on the type of history they have had regarding the quality of products, materials, and services they provide.

Put quality control systems on incoming parts and equipment to ensure observations are made concerning their specifications and standards.

Keep the communication lines with suppliers open when any of them raise concerns about the quality.

Risk Management Plan


Use a proactive risk management technique that highlights the occurrence of risks along with their evaluation, mitigation, and monitoring from various stages throughout the project.

Roles and Responsibilities

Project Manager: Establish the overall responsibility for monitoring and controlling risk management activities and ensuring that risks are appropriately handled.

Risk Management Team: TA Key stakeholders are responsible for identifying, assessing, and managing project risks. They are a cross-functional team.

Department SME: They have subject matter knowledge of sterilization processes, equipment, and standards (Blundo et al., 2021).

Engineer, Architect, Contractor: Involve in the identification and mitigation associated with design, construction, and equipment installation for cultivating risk together.

Quality Assurance Officer: Follows risk management activities recording and accomplishes recorded measures implemented.

Budget and Schedule

Budget contingency funds should be used within the project budget to cover unexpected risks and prevent spending overages in some areas.

Perform a qualitative assessment of the various potential project factors that could challenge the reliability of the schedule. Therefore, implement an acceptable plan with suitable delays that account for surprise risks such as equipment lead times or construction difficulties.

Risk Categories

Technical Risks: Installation-related risks, design-related risks, and changeover or assimilation of new technology/equipment.

Regulatory Risks: Risk attached to the neglectful arrangement about ignoring the regulatory standards and accreditation requirements.

Operational Risks: The risks that emerge from conducting routine procedures and operational activities, equipment snags, or other related inefficiencies linked to workflow.

Financial Risks: Under budget, unforeseen costs or overshoots, and inadequately funded projects (Blundo et al., 2021).

Stakeholder Risks: Conflict of Interest risk where stakeholder priorities shift, communication issues occur, or other conflicts of interest occur.

Risk Probability and Impact

Identify the level of risk and what will be measured as a successful or unsuccessful outcome for every identified risk, cost, schedule, quality, and patient care.

The essence of risk management as a process is to reduce the risk list that was distinguished previously (World Health Organization, 2021).

Risk Documentation

Prepare an appropriate risk register, where all the risks that have been identified will be listed, including their possible impacts on success, mitigation strategies, and who is responsible for each.

Get into the practice of reviewing and updating the risk registers during phases of the project lifespan to ensure that, as a result, emerging risks like this one are detected in time (Blundo et al., 2021).


Blundo, D. S., Sánchez, R. G., Salgado, S. M., & Muiña, F. E. G. (2021). Flexibility and resilience in corporate decision making: A new sustainability-based risk management system in uncertain times. Global Journal of Flexible Systems Management, 22(2).



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