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CHE170 > Final Exam nga naka INC > Flashcards

Final Exam nga naka INC Flashcards

1
Q

Define emergency

A

a potentially life-threatening
situation usually occurring suddenly
and unexpectedly

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2
Q

Define disaster

A

a sudden, calamitous event bringing
great damage, loss or destruction.

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3
Q

Differentiate emergency and disaster.

A

Emergency
- a potentially life-threatening
situation usually occurring suddenly
and unexpectedly.
Disaster
- a sudden, calamitous event bringing
great damage, loss or destruction.

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4
Q

2 Types of Emergencies

A

Man-made emergencies
- events caused by man’s negligence in
handling his technology.

Natural emergencies
- events that are caused by the forces of
nature.

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5
Q

Examples of Man-Made Emergencies

A

❑ Chemical Leak / Spill
❑ Structure Collapse
❑ Industrial / Community Fire
❑ Construction Cave-In
❑ Major Transportation Accident
❑ Public Demonstration

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6
Q

Examples of Natural Emergencies

A

❑ Drought
❑ Floods
❑ Volcanic Eruption
❑ Earthquake
❑ Thunderstorms

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7
Q

Cyclical Nature of Emergency Management

A

Prevention
Preparedness
Response
Recovery

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8
Q

Emergency Prevention

A

The practice of activities designed to
prevent accidents and emergencies from
occurring.

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9
Q

Procedures of Emergency Prevention

A

Procedures:
❑ Fire Prevention
❑ Safety and Health Review
❑ Inspection

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10
Q

Emergency Preparedness

A

Encompasses all activities that are necessary
to prepare people and organizations to
respond to emergencies and disasters.

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11
Q

Procedures of Emergency Preparedness

A

Procedures:
❑ Personnel Training
❑ Drills and Exercises
❑ Supplies and Equipment
❑ Protection of Records
❑ Mutual Aid

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12
Q

EMERGENCY ACTION PLAN

A

Emergency design plan is a written set of
instructions that outlines what workers
and people at workplace should do in a
emergency

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13
Q

Emergency Response

A

Follows preparedness and involves life
saving and protection activities that are
implemented during an emergency.

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14
Q

Procedures of Emergency Response

A

Procedures:
❑ Direction and Control
❑ Communications
❑ Emergency Shutdown Procedures
❑ Fire and Spill Procedures
❑ Facility Evacuation
❑ Security Considerations
❑ Public Relations and Emergency Information
❑ Coordination between Facility and Offsite
❑ Agencies

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15
Q

Emergency Recovery

A

Embodies all activities necessary to bring
the organization back to normal or routine
operations.

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16
Q

Elements of an Emergency
Preparedness Program

A

➢ Review Hazard
➢ Evaluate Resources
➢ Develop Emergency Plan & Procedure
➢ Integrate with community plan
➢ Conduct training
➢ Educate the public
➢ Conduct drills and exercises

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17
Q

EMERGENCY RESPONSE TEAMS
DURING AN IMMINENT EMERGENCY

A

Security
Fire Control
First Aid
Damage Assessment and Recovery
Emergency Service
Supplies

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18
Q

Procedures of Emergency Recovery

A

Incident Investigation
Damage Assessment
Cleanup and Restoration
Business Interruption
Claims Procedures

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19
Q

4 Stages of Emergency Procedure

A

Preliminary Action
- the preparation of a plan tailored to meet the specific
requirements of the side, product and surroundings

Action when emergency is imminent
❑ This stage will feature the assembly of emergency key
personnel
❑ Advance warning to external authorities

Action During the Emergency
❑ Decision making personnel has the authority and is
responsible for the precise and rapid judgements to
ensure that appropriate actions follow the decisions
made

Ending Emergency
❑ A procedure for declaring plant, systems and specific
areas safe
❑ Declaration that processes and operation may
continue

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20
Q

What is GMP?

A

Part of a quality management system
to ensure that products are consistently
produced and controlled to the quality
standards appropriate to their intended
use and as required by the marketing
authorization.

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21
Q

What is cGMP?

A

Accordingly, the “C” in CGMP stands for “current”, requiring companies to use technologies and systems that are up-to-date to comply with the regulations.

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22
Q

Difference bet GMP and cGMP

A

GMP
- covers the required standards of an industry.
- less expensive to implement and maintain.
- minimum standards required for an industry.

cGMP
- ensures that a company is following the latest regulations.
- more expensive due to additional testing and state-of-the-art technologies.
- companies make sure that they are compliant with the most recent rules and regulations.

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23
Q

Objectives of cGMP

A
  • cGMP regulations assure that quality is built into the design and manufacturing process at every step.
  • Manufacturing facilities are in good condition.
  • Equipment’s are properly maintained and calibrated.
  • Employees are qualified and fully trained.
  • Processes that are reliable and reproducible.
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24
Q

Personnel Guidelines on cGMP

A
  • Personnel must be qualified and trained for their roles.
  • Written procedures (SOPs) should be followed.
  • Accurate and detailed documentation is essential.
  • **Quality control and quality **assurance personnel play critical roles.
  • Ongoing training and staying current with industry standards are required.
  • Responsibility, accountability, and reporting deviations are important.
  • **Hygiene and gowning standards **must be followed to prevent contamination.
  • Effective communication and collaboration among personnel are essential for maintaining cGMP compliance. Compliance ensures product safety and quality in pharmaceutical manufacturing.
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25
Q

Equipment guidelines on cGMP

A
  • Equipment shall be located, designed, constructed, adapted, and maintained to suit the operation to be carried out.
  • Equipment should be calibrated, checked, labeled, sterilized, and accompanied with SOP.
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26
Q

Facility guidelines on cGMP

A
  • Premises must be located at a place where it
    can minimize risks of cross-contamination and can support efficient operations.
  • Minimize risks of errors
  • Permit effective cleaning and effective maintenance
  • Avoid cross-contamination, build-up of dirt and dust
  • Maximum protection against entry of insects, birds, and animals
  • Finishing floors, walls, and ceilings should be smooth, impermeable, hard-wearing, easy to clean
  • Buildings and areas shall be of suitable size to facilitate production, cleaning, and maintenance properly.
  • Lighting: Adequate lighting shall be provided in all areas
  • Proper Ventilation, air filtration, air heating and cooling
  • Plumbing: drains shall be of adequate size and, where connected directly to a sewer
  • Adequate Washing and toilet facilities
  • Sanitation: buildings should be free of infestation (rodents, birds, etc)
  • Maintenance: each area shall be maintained in a good state of repair
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27
Q

Internal Inspection

A

A regular independent inspection is necessary to evaluate the manufacturer’s compliance with cGMP in all aspects of manufacturing

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28
Q

BMR and MFR

A

Batch Manufacturing Record (BMR) and Master Formulation Record (MFR)

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29
Q

WHAT IS A
JOB?

A

Any activity (mental or physical
or both) that has been assigned
to an employee as a
responsibility and carries with it
both positive and/or negative
consequences based on the
performance of that job.

30
Q

WHAT IS A
HAZARD?

A

An unsafe condition or practice that
could cause injury, illness, property
damage, or death.

31
Q
A
32
Q

WHAT IS EXPOSURE?

A

When an employee enters a “danger zone” by virtue of their proximity to the hazard.

33
Q

WHAT IS A JOB HAZARD ANALYSIS?

A

The breaking down of a job into its
component steps and then
evaluating of each step, looking for
hazards. Each hazard is then
corrected or a method of worker
protection (safe practice or PPE) is
identified and made a standard of
operation.

34
Q

PURPOSE OF JHA

A

▪ Effective JHA will help the employer recognize and
control hazards and exposures in the workplace.
▪ How the employee’s perception of a “hazard” differ from that of the employer or supervisor?

35
Q

Why is a JHA more effective than walk-around inspections in reducing accidents in the workplace?

A

Ø A safety walk-around is when a line manager or supervisor observes work taking place, inspects the workplace, and discusses safety performance with staff based on their observations.
Ø It is not to be confused with a safety inspection, which is a formalized process of documenting safety hazards and unsafe work practices.
Ø JHA is breaking down of a job into its component steps and then evaluating of each step, looking for hazards to develop solutions and eliminate or control the hazards.

36
Q

Probability

A

Probability is defined as:
-the chance that a given event will occur.
- the likelihood that the risk could arise.

37
Q

How can we determine the safety
probability?

A

We can determine the safety probability based on the following:
1.The number of employees exposed;
2.The frequency and duration of exposure;
3.The proximity of employees to the
danger zone.
4. Factors which require work under stress;
5. Lack of proper training & supervision or improper workplace design; or
6. Other factors which may significantly influence the degree of probability of an accident occurring.

38
Q

Probability Rating

A

▪ Low - If the factors considered indicate it would be **unlikely that an accident could occur;
▪ Medium - If the factors considered indicate it would be likely that an accident could occur; or
▪ High -** If the factors considered indicate it would be very likely that an accident could occur.

39
Q

Severity

A

The degree of injury or illness which
is reasonably predictable.

40
Q

Types of Severity

A

▪ Other Than Serious - Conditions that could cause injury or illness to employees but would not include
serious physical harm (example: first aid case)
▪ Serious Physical Harm - Example: all recordable injuries and illnesses (example: LTAs)
▪ Death

41
Q

Strategies Involved In JHA

A

Inventory- inventory the tasks.
Identify- identify critical tasks.
Break- break tasks down into basic steps or activities.
Pinpoint- pinpoint loss exposures
Control and manage- control and manage existing and potential hazards.

42
Q

Job Hazard Analysis

A
  • A proven tool to determine unsafe acts/practices or conditions in a job by analyzing the job step by step and identifying potential hazards in each step.
  • An effective method of reviewing the individual steps in performing a job in order to develop solutions to eliminate or control the hazard.
43
Q

Basic Steps in doing JHA

A
  • Select- select the job to be analyzed.
  • Break- break the job down into successive steps.
  • Identify- identify the hazards and potential accidents.
  • Develop- develop safe procedures to eliminate, control, and manage hazards.
44
Q

What is an Accident?

A

Any undesired, unplanned
event arising out of
employment which results in
physical injury or damage to
property, or the possibility
of such injury or damage.

45
Q

Why do we Investigate?

A

The investigation should identify the
causes of the accident so that
controls can be put in place to
prevent the similar similar incident from
happening again.

46
Q

In 1931, Herbert stated in his book that for
every accident that causes a major injury, there are 30
accidents that cause a minor injury and 300 accidents
that cause no injury. Unsay name atung pyramid niya?

A

Heinrich Pyramid

47
Q

Accident Investigation

A

A methodical effort to collect and interpret the facts of accident.

48
Q

Purpose of Accident
Investigation

A
  • To establish all facts
  • To draw conclusion
  • To make recommendations
  • To prevent recurrence
49
Q

Reasons Why Accidents Are Not Reported

A
  • **Reason 1: **Natural fear many people have of being associated with anaccident event.
  • Reason 2: Idea of investigating a situation that has resulted in some degree of loss.
  • Reason 3: Reflect unfavorably on their own performance or that of their department.
  • Reason 4: Simply do not wish to interrupt work production.
50
Q

Types of Accident to be Reported

A
  • Fatal Accidents
  • Accident-causing injury or illness
  • Diseases
  • Dangerous occurrences
  • Near misses
51
Q

Who Should Conduct Accident Investigation?

A

Supervisors or Safety Officer/Man

52
Q

4 Steps of Investigation Process

A
  • Control the scene.
  • Gather data.
  • Analyze data.
  • Write report.
53
Q

Pertinent Data for Incident Reporting

A
  • Accident Title
  • Date, Time, Location
  • Persons Involved
  • Witnesses and their Statements
  • Work and Environmental Conditions
  • Immediate Actions
54
Q

MORT

A

Management Oversight and Risk Tree

54
Q
A
55
Q

The simple causation model shown attempts to illustrate that the causes of any incident can be grouped into five categories -

A

task, material, environment, personnel,
and management.

56
Q

What must be in an incident REPORT?

A
  • Background Information
  • Account of the Accident
  • Discussion
  • Recommendations
57
Q

Why do we need to do incident reports?

A

Well, It is in the Law….
From Rule 1050, of the OSH Law, All work
accidents or occupational illnesses resulting in
disabling conditions or dangerous occurrence
shall be reported

58
Q

WHAT IS A HAZARD ANALYSIS AND CRITICAL POINT SYSTEM?

A

Under the HACCP management system,
biological, chemical, and physical hazards
are analyzed and controlled at every stage
of the production process, from raw
material procurement and handling to final
product manufacturing, distribution, and
consumption.

59
Q

HACCP

A

HAZARD ANALYSIS AND CRITICAL
CONTROL POINTS

60
Q

To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan.

A

Control (verb):

61
Q

The state wherein correct procedures are being followed and criteria are being met.

A

Control (noun)

62
Q

Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

A

Control measure

63
Q

Failure to meet a critical limit

A

Deviation

64
Q

A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item

A

Flow diagram

65
Q

A point, procedure, operation or stage in the food chain including raw materials, from primary production to final consumption

A

Step

66
Q

A document prepared in accordance with the principles of HACCP to ensure control of hazards that are significant for food safety in the segment of the food chain under consideration

A

HACCP plan

67
Q

A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect

A

Hazard

68
Q

The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan

A

Hazard analysis

69
Q

SEVEN (7) PRINCIPLES OF AN HACCP SYSTEM

A
  • CONDUCT A HAZARD ANALYSIS
  • DETERMINE THE CRITICAL CONTROL POINTS (CCPS)
  • ESTABLISH CRITICAL LIMIT(S)
  • ESTABLISH A SYSTEM TO MONITOR CONTROL OF THE CCP
  • ESTABLISH THE CORRECTIVE ACTION TO BE TAKEN WHEN MONITORING INDICATES THAT A PARTICULAR CCP IS NOT UNDER CONTROL
  • ESTABLISH PROCEDURES FOR VERIFICATION TO CONFIRM THAT THE HACCP SYSTEM IS WORKING EFFECTIVELY.
  • ESTABLISH DOCUMENTATION CONCERNING ALL PROCEDURES AND RECORDS APPROPRIATE TO THESE PRINCIPLES AND THEIR APPLICATION

CHE170 (2 decks)

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