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陳維峰中央研究院

Laboratories for the 21st Century (Labs21) 21世紀實驗室管理趨勢

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Management system integration

• Laboratory management system is compatible with the ISO 9001:2000 (Quality), ISO 14001:2004 (Environmental) and OHSAS 18001:2007 (Occupational Health and Safety) management systems standards, in order to facilitate the integration of all such management systems of an organization.

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Laboratory management systems- Approach

• In order to improve laboratory management the organization needs to focus on the causes of non-conformities and undesirable events.

• Systematic identification and correction of system deficiencies leads to improved performance and control of laboratory.

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QUALITY CONTROL

QUALITY ASSURANCE

QUALITY SYSTEM

Stages of Quality - Hierarchy

Implementing quality and control

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Total Quality Management

• TQM is a philosophy of managing a set of business practices that emphasises continuous improvement in all phases of operations, 100 percent accuracy in performing tasks, involvement and empowerment of employees at all levels, team-based work design, benchmarking, and total customer satisfaction

• TQM is about continuously improving the performance of every task and value chain activity

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Keys to a successful Laboratory management system

The key factors in establishing and implementing asuccessful management system include:• Commitment by top management: 1.providing adequate resources, prioritization and communication of laboratory management policy; 2.integrating of management throughout the organization; 3.identifying opportunities for improvement and prevention, determining root causes and preventing recurrence.

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Key Elements of Management System

Policy development

Organisational development

Developing techniques of planning, measuring and reviewing

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Keys to a successful laboratory management system

• Focus on continual improvement: 1.making continual improvement an objective for every individual in the organization; 2.using periodic assessment against established risk-criteria to identify areas for potential improvement; 3.continually improving the effectiveness and efficiency of processes; 4.promoting prevention activities; 5.providing personnel in the organization with appropriate education and training including the methods and tools of continual improvement; 6.establishing measures and goals for improvement; recognizing improvement.

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Management systems approach• An effective management system approach should be built on

the concept of continual improvement through a cycle of planning, implementing, reviewing and improving the processes and actions that an organization undertakes to meet goals.

• This is known as the PDCA (Plan-Do-Check-Act) principle:

Plan: Planning, including identification of hazard and risk and establishing goals,Do: Implementing, including training and operational issues,Check: Checking, including monitoring and corrective action,Act: Reviewing, including process innovation and acting to make needed changes to the management system

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Labs21 Missions

• Labs21 aims to improve laboratory energy and water efficiency, encourage the use of renewable energy sources, and promote environmental stewardship within the laboratory community.

• The guiding principle of the Labs21 program is that improving the energy efficiency and environmental performance of a laboratory requires examining the entire facility from a “whole building” perspective, rather than focusing on a specific component.

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Why Laboratories and High Performance Facilities?

• The typical laboratory, for example, uses far more energy and water per square foot than the typical office building due to intensive ventilation requirements and other health and safety concerns.

• On a square-foot basis, laboratories often consume four to six times as much energy as typical office buildings.

• Because the requirements of laboratories and related high performance facilities differ so dramatically from those of other buildings, a clear need exists for an initiative exclusively targeting these facilities.

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• The primary guiding principle of the Labs21 approach is that improving the energy efficiency and environmental performance of these facilities requires examining the entire facility from a "whole building" perspective.

• Adopting this perspective allows owners to improve the efficiency of the entire facility, rather than focusing on specific building components.

• As Labs21 participants understand, improving the efficiency of individual components without examining their relation to the entire system can eliminate opportunities to make other more significant efficiency improvements.

Why Laboratories and High Performance Facilities?

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Labs21 is dedicated to the pursuit of

sustainable,high performance, and low-energy

laboratories that will:• Minimize overall environmental impacts. • Protect occupant safety. • Optimize whole building efficiency on a life-c

ycle basis. • Establish goals, track performance, and shar

e results for continuous improvement.

Labs21 Approach

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To demonstrate their commitment to this philosophy, Labs21 Partners commit to the following:

• Adopt voluntary goals. • Assess opportunities from a "whole buildings" approach. • Use life-cycle cost analysis as an important decision-making tool. • Incorporate a comprehensive, whole building commissioning process

into new construction and retrofit projects. • Employ a range of energy and water efficiency strategies. • Measure energy and water consumption and track emission reductions. • Evaluate on-site power generation, combined heat and power

technologies, and renewable power purchases. • Build with "green" construction materials. • Promote energy and water efficiency efforts. • Expand beyond the laboratory building.

Labs21 Approach

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• Labs21 seeks to create environmental showcase laboratories by encouraging laboratory owners, operators, and designers to adopt the "Labs21 Approach."

• This strategy involves taking an initial evaluation of a laboratory's energy use from a comprehensive perspective when considering efficiency improvements.

• This requires focusing on all of a laboratory's energy systems and wastes, including its HVAC and electrical power supply, rather than focusing on specific energy-using components.

Labs21 Approach

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Allows laboratory owners and operators to pursue integrated energy and water conservation measures with significantlyhigher efficiencies and cost savings than the traditional approachof addressing components sequentially or individually.

Adopting the Labs21 Approach will encourage laboratories to: • 1) make capital investment decisions based on life cycle cost savings; • 2) pursue advanced, energy-efficient HVAC technologies; • 3) design systems that recover and exchange waste heat and

other forms of free energy; • 4) incorporate renewable energy systems.

The resulting showcase facilities will reduce emissions, streamline energy and

water usage, and decrease overall costs—all while preserving the integrity of the

laboratory's mission.

Labs21 Approach

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Green Buildings• Designing, constructing, operating, and

maintaining buildings involves large amounts of energy, water, and other resources and creates significant amounts of waste.

• The building process also impacts the environment and ecosystem surrounding the building site. Even after buildings are constructed, occupants and building managers face a host of challenges as they try to maintain a healthy, efficient, and productive work environment.

• EPA addresses these challenges by promoting energy and resource efficiency, waste reduction and pollution prevention practices, indoor air quality standards, and other environmental initiatives for both new construction and existing buildings.

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Building systems commissioning

• A process designed to ensure that the finished facility, equipment and systems will operate in accordance with the design intent and construction documents.

• It is recommended that commissioning be implemented early in the planning phase through to the construction and certification.

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Protect occupant safety

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Risk Analysis

Risk Assessment Risk Management

Risk Communication

Science based+Explanation

Policy based+Implementation

Interactive exchange of information and opinions

concerning risks

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Risk Assessment

Risk assessments on lab proceduresShould be done before initiating them.They should answer the following:• What are the hazards?• What might happen? • How likely is it to happen?• How serious are the consequences if it

happens?• What are the possible exposures?• How can I mitigate exposure?• What is the worst that can happen?• Familiarity affects your perception of risk.

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Risk Management1.評估實驗室個人及個人安全需求To evaluate personal or personnel safety in a laboratory workplace. 2.評估適當的防護等級及操作需求To determine the appropriate containment level and physical engineering, and operational requirements for work with the agents.3.決定個人防護裝備To determine the appropriate personal protective equipment requirements. 4.決定訓練需求To determine training needs5.決定設置機構之責任義務To quantify institutional liability6.符合法規需求To comply with legislated requirements

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Biorisk - A Global Issue

The management of biosafety and biosecurity (collectively know as biorisk) have become a vital global issue, especially in light of the laboratory-acquired cases of SARS in Singapore, Taiwan and China in 2004.

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Not without risk • A feature of these cases is that often there is a failure of the sa

fety management system, as opposed to deficiencies in the facility and equipment employed.

• It is also our experience that in this field a great deal of emphasis is placed on the design and construction of the facility itself, but rather less attention can sometimes be paid to how the facility will be run and the staff deemed competent with regard to biosafety and biosecurity.

• This can be partly due to the difficulty in finding experienced personnel available in this field, but also a lack of the necessary structures and frameworks around which facilities can build adequate biorisk management systems.

• Such problems exist in Europe and North America, but can be particularly severe in developing countries.

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Building a “Commissionable” Containment Facility:

A step-by-step walkthrough

How NOT to do it ？ How-in my experience to do it ？

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Facility Design and Construction Engineering Design Issues

Laboratory Characteristics

Guidelines,Standards,Codes and Regulations

Cotainment BarriersArchitectural Design Issues

CommissioningMechanical Design Issues

Other Engineering Design Consideration

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Facility Design and Construction: Engineering Design Issues

Mechanical design issues HVAC system,air

flow,diffuser,HEPA,damper,BSC,plumbing systems,drainage,autoclave,decontamination

ports,other critical componentsOther engineering design consideration

space pressure control,control system,space pressure control,flow

tracking,alarm,monitor,sensor,electrical issues,phone/intercom,door

interlock,penetration,security/entry control

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Commissioning• Verification of phyical construction and performance of critical

containment components• Process designed to ensure that the finished facility,equipment

and system will operate in accordance with the design intent and construction documents

• Is one part of the overall certification process

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Certification• A matrix of critical containment components to be

verified during initial certification is provided below. Operational protocols must also be established before work with pathogens at the specified containment level can be carried out.

• Training of personnel is a critical aspect of this process and may involve initial work with pathogens normally requiring a lower containment level.

• Users must understand the containment systems and their operation in addition to scientific procedures. Detailed records of the certification process and test results must be maintained.

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What is certification ?

• Certification=

completion of commissioning and verification that

(1)facility’s physical critical containment components &

(2)operational protocals meet the requirements as outlined in the laboratory biosafety guidelines

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Facility is certified, now what……

Re-certification

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Recertification

• Recertification of certain containment components should also be performed, the nature and frequency of which depend on a variety of factors.

• For example, verification of directional airflow, detection of any visual leaks in the room perimeter, recalibration of sensitive controllers and gauges, and monitoring of the efficacy of sterilization systems such as autoclaves can all be performed on a routine basis without disruption to the operation of the containment facility.

• Monitoring the resistance across a HEPA filter (i.e., using pressure monitoring devices) installed into air handling systems will provide information as to the necessity and frequency of replacing HEPA filters.

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What is a Re-certification?

• Re-certification=

Verification that the(1)facility’s physical critical containment components &

(2)operational protocals continue to comply with the

laboratory safety guidelines

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Why do we re-certify?

We re-certify to ensure that the systems are still working as designed, and that laboratory procedures have been implemented to account for any protocal changes.

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Re-Commissioning

• Re-verification of phyical construction and performance of critical containment components

• Process designed to ensure that the finished facility,equipment and system will operate in accordance with the design intent and construction documents

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Third Party Testing

Certification documentation for each equipment tested.

Assist in training on proper use of equipments.

Provide assistance in troubleshooting problems with

equipment and contamination.

Monitoring proper decontamination, testing, and

recertification of equipments that have been repaired or

moved to a new location.

• Retesting the integrity of the room perimeter and ductwork is necessary after any structural change.

• Retesting of the HVAC control systems for fail-safe operation is not necessary unless the system has undergone logic changes or upgrades.

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Thank You For Your Attention