The document outlines Monash University's processes for corrective and preventive action according to relevant standards and legislation. It defines key terms and describes the procedures for addressing non-conformances and hazards identified through workplace inspections, audits, incident reporting, and other review activities. Records of corrective actions, inspections, audits, and issues discussed must be kept for five years, while some like hazards and incidents must be kept indefinitely.
In pharmaceutical industry any investigation is concluded with "Human error" as root cause then understanding needs to be built for the root cause analysis.
It is very easy to conclude as Human error, but difficult to justify.
These Presentation includes
1. Trend of Human error in various industries.
2. Facts and Finding on Human error
3. Definition of Human error.
4. Viewpoint "Human Error"
5. Understanding of Human error part-1 and 2.
6. Contributing factors for human error.
7. Human weaknesses.
8. Human limitations.
9. Let's Have part (Secret game zone)
10. Human error investigation
11. Human error reduction
12. Thank you note
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
[Note: This is a partial preview. To download this presentation/checklists, visit:
https://www.oeconsulting.com.sg/training-presentations]
This is a set of 5S audit checklists for manufacturing companies and office/service environments.
There are a total of 25 manufacturing-related and 20 office-related evaluation criteria spanning the 5S principles. Each criteria is evaluated against a five-point scale.
The maximum possible score is 100 organized into five scoring bands:
81-100: Excellent
61-80: Good
41-60: Fair
21-40: Poor
1-20: Very Poor
This 5S audit worksheet can be applied generally to all manufacturing and office departments. You may change the audit criteria to suit your specific needs and situation. With the 5S Excel worksheet, you can instantly view your monthly 5S audit results visually with a Radar Chart and a Monthly Trend Chart. The results can be compared between departments and sites.
Start auditing your 5S performance today and map out an actionable plan based on the audit findings!
CONTENTS
1. Summary of 5S Principles
2. 5S Audit Checklist - Manufacturing
3. 5S Audit Checklist - Office / Service
Note: This package consists of a 5S audit checklist in PowerPoint and Excel formats.
Evaluating Out Of Tolerance Instruments WebinarTranscat
Join us as Phil Mistretta, Transcat's Manager of Metrology, discusses the process of evaluating out of tolerance (OOT) instruments. This webinar will help you understand how instrument selection can help you:
-Develop an OOT evaluation strategy
-Identify elements to reduce evaluation time
-Analyze the impact of OOT measurements on your pr
-Reduce producer and consumer risk
Root Cause Analysis - Tools, Tips and Tricks to Get to the Bottom of Root CauseCraig Thornton
This webinar discusses and investigates how to conduct root cause analysis. Root cause analysis is something that companies really struggle with. There will be plenty of practical advice in the webinar to help with you understand the concepts and the tools.
If you would like to watch the recording of this webinar then copy and paste the below link into your web browser:
http://www.mangolive.com/blog-mango/root-cause-analysis-tools-webinar
Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
In pharmaceutical industry any investigation is concluded with "Human error" as root cause then understanding needs to be built for the root cause analysis.
It is very easy to conclude as Human error, but difficult to justify.
These Presentation includes
1. Trend of Human error in various industries.
2. Facts and Finding on Human error
3. Definition of Human error.
4. Viewpoint "Human Error"
5. Understanding of Human error part-1 and 2.
6. Contributing factors for human error.
7. Human weaknesses.
8. Human limitations.
9. Let's Have part (Secret game zone)
10. Human error investigation
11. Human error reduction
12. Thank you note
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
[Note: This is a partial preview. To download this presentation/checklists, visit:
https://www.oeconsulting.com.sg/training-presentations]
This is a set of 5S audit checklists for manufacturing companies and office/service environments.
There are a total of 25 manufacturing-related and 20 office-related evaluation criteria spanning the 5S principles. Each criteria is evaluated against a five-point scale.
The maximum possible score is 100 organized into five scoring bands:
81-100: Excellent
61-80: Good
41-60: Fair
21-40: Poor
1-20: Very Poor
This 5S audit worksheet can be applied generally to all manufacturing and office departments. You may change the audit criteria to suit your specific needs and situation. With the 5S Excel worksheet, you can instantly view your monthly 5S audit results visually with a Radar Chart and a Monthly Trend Chart. The results can be compared between departments and sites.
Start auditing your 5S performance today and map out an actionable plan based on the audit findings!
CONTENTS
1. Summary of 5S Principles
2. 5S Audit Checklist - Manufacturing
3. 5S Audit Checklist - Office / Service
Note: This package consists of a 5S audit checklist in PowerPoint and Excel formats.
Evaluating Out Of Tolerance Instruments WebinarTranscat
Join us as Phil Mistretta, Transcat's Manager of Metrology, discusses the process of evaluating out of tolerance (OOT) instruments. This webinar will help you understand how instrument selection can help you:
-Develop an OOT evaluation strategy
-Identify elements to reduce evaluation time
-Analyze the impact of OOT measurements on your pr
-Reduce producer and consumer risk
Root Cause Analysis - Tools, Tips and Tricks to Get to the Bottom of Root CauseCraig Thornton
This webinar discusses and investigates how to conduct root cause analysis. Root cause analysis is something that companies really struggle with. There will be plenty of practical advice in the webinar to help with you understand the concepts and the tools.
If you would like to watch the recording of this webinar then copy and paste the below link into your web browser:
http://www.mangolive.com/blog-mango/root-cause-analysis-tools-webinar
Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
Muravin The fundamentals of Structural Health Monitoring using Acoustic Emis...mboria
Structural Health Monitoring (SHM) is an emerging field of modern engineering that deals with diagnosis and monitoring of structures during their operation. Increasing requirements for safety, development of tools and criteria for condition based maintenance (CBM), cost reduction are all driving development of SHM methods in different industries. The primary goal of SHM is detection, identification, assessment and monitoring of flaws or faults/conditions that affect or may affect in a future safety or performance of structures. SHM combines elements of non-destructive testing and evaluation, condition/process monitoring, statistical pattern recognition and physical modeling. Acoustic emission method uniquely fits to the concept of SHM due to its capabilities to examine, monitor structures and assess structural integrity during their normal operation.
In this work, the fundamental definitions and principles of application of Acoustic Emission as a method of SHM are elaborated. This includes:
• Recommended terminology and definitions of SHM by the AE method.
• Outline of recommended process of AE SHM.
• Fundamental assumptions and principals regarding development of new SHM procedures, selection of equipment and methods of data acquisition and analysis, diagnosis, monitoring and prediction by AE SHM.
The developed principals provide an outline for systematic and standard development of new SHM applications based on Acoustic Emission method.
1. OHS CORRECTIVE AND PREVENTIVE ACTION AS/NZS 4801, OHSAS 18001
OHS20309
SAI Global
AT MONASH UNIVERSITY
November 2010
TABLE OF CONTENTS
1. PURPOSE ............................................................................................................................. 2
2. SCOPE .................................................................................................................................. 2
3. ABBREVIATIONS ................................................................................................................. 2
4. DEFINITIONS ........................................................................................................................ 2
4.1 CORRECTIVE ACTION ........................................................................................................................................ 2
4.2 MACHINERY/EQUIPMENT ................................................................................................................................... 2
4.3 MONASH CONTROLLED ENTITY ........................................................................................................................... 2
4.4 NON CONFORMANCE ......................................................................................................................................... 3
4.5 OHS AUDIT ...................................................................................................................................................... 3
4.6 OHS HAZARD ................................................................................................................................................... 3
4.7 PREVENTIVE ACTION ......................................................................................................................................... 3
4.8 WORKPLACE INSPECTIONS ................................................................................................................................ 3
5. CORRECTIVE AND PREVENTIVE ACTION ......................................................................... 4
6. RECORDS ............................................................................................................................. 6
7. REFERENCES ...................................................................................................................... 6
7.1 LEGISLATION ................................................................................................................................................... 6
7.2 AUSTRALIAN STANDARDS .................................................................................................................................. 6
7.3 MONASH UNIVERSITY OHS DOCUMENTS .............................................................................................................. 6
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Date of first issue: August 2007 Date of last review: November 2010 Date of next review: 2013
25/10/2010
2. 1. PURPOSE
This document summarises the processes used for corrective and preventive action at
Monash University in accordance with the requirements of the Occupational Health and
Safety Act (2004) and associated regulations and with Standards AS/NZS 4801:2001
Occupational Health & Safety Management Systems – specifications with guidance for use
and OHSAS 18001:2007 Occupational Health & Safety Management Systems –
requirements
Preventive and corrective action is identified from inspection and testing, audits, hazard and
incident reporting and other reviews of the Monash University OHS management system.
Corrective and preventive action is implemented to:
• detect and correct errors or problems in OHS management;
• prevent recurrences of errors or problems in OHS management; and
• ensure that systems are in place to prevent the occurrence of errors or problems in
OHS management.
2. SCOPE
The processes described apply to OHS management on the Australian campuses of Monash
University and to Monash controlled entities.
3. ABBREVIATIONS
HSR Health and Safety Representative
OHS Occupational health and safety
OH&S Occupational Health and Safety Branch
4. DEFINITIONS
4.1 CORRECTIVE ACTION
Corrective action is action taken after an incident to correct the problem and to
prevent a recurrence.
4.2 MACHINERY/EQUIPMENT
For the purposes of this document, machinery/equipment is defined as a system or
device used for performing work which may or may not be coupled to a power
source and any associated auxiliary equipment. This includes pressure equipment,
powered equipment, hoists, powered mobile plant, lasers, turbines, explosive-
powered tools, scaffolds and temporary access equipment in laboratories, studios
and workshops.
For the purposes of this document:
• machinery/equipment does not include lifts and cranes, as the processes
required for these machines are covered in the document OHS monitoring,
measurement & registration at Monash University.
• personal computers and office equipment are excluded from these
procedures.
4.3 MONASH CONTROLLED ENTITY
Monash controlled entities (e.g. companies) include entities where Monash can
control decision making, directly or indirectly, in relation to the financial and
operating policies so as to enable the entity to operate with it in pursuing the
objectives of Monash University.
For the remainder of this document, a Monash controlled entity will be referred to as
a controlled entity.
corrective-action.doc, v2 Responsible Officer: Director, OH&S Page 2 of 6
Date of first issue: August 2007 Date of last review: November 2010 Date of next review: 2013
25/10/2010
3. 4.4 NON CONFORMANCE
A non conformance is an activity or item that does not conform to the policy,
procedures or other requirements of the Monash University OHS management
system.
4.5 OHS AUDIT
An OHS audit is a systematic and documented verification process of objectively
obtaining and evaluating evidence to determine whether the university is conforming
to planned OHS arrangements.
4.6 OHS HAZARD
An OHS hazard is anything that has the potential to cause injury or illness to people,
damage to property or the environment or a combination of these. The situation
could involve a task, chemical, item of machinery/equipment or unacceptable
behaviour.
4.7 PREVENTIVE ACTION
Preventive action is pro-active and involves taking action before an incident occurs,
e.g. by identifying a hazard and taking steps to prevent any incident which may
result from the hazard.
4.8 WORKPLACE INSPECTIONS
Workplace inspections are planned, systematic appraisals of physical aspects of the
workplace that identify OHS hazards and non-compliances with Monash University
policy, procedures and practices and legal requirements.
corrective-action.doc, v2 Responsible Officer: Director, OH&S Page 3 of 6
Date of first issue: August 2007 Date of last review: November 2010 Date of next review: 2013
25/10/2010
4. 5. CORRECTIVE AND PREVENTIVE ACTION
The corrective and preventive action undertaken as part of the Monash University OHS management system is outlined in the table below.
Activity Procedure Corrective action Preventive action Requirements
Workplace Workplace inspection Addressing non- Implementing improvements • Actions necessary are recorded on
inspections program conformances with OHS to OHS systems and inspection worksheets;
procedures and systems procedures upon the • Tasks and date of completion are
OHS monitoring, identified during inspection identification of hazards assigned to the most appropriate person
measurement and (using reference checklist) to complete the task;
registration at Monash
• Form is returned to safety officer when
University
inspection complete, who monitors that
the action is completed in a timely fashion.
OHS audits OHS audits at Monash Addressing non- Implementing improvements • Audit report provided by OH&S and
conformances with OHS to OHS systems and closing meeting outlines actions to be
procedures and systems procedures taken including timelines;
identified during audits • OHSE consultant/manager monitors and
assists with implementation;
• OH&S monitors completion of actions at
end of time period allocated.
Hazard & incident Procedures for hazard & Addressing problems and Addressing problems and • Hazard or incident reported;
reporting incident reporting, non-conformances with OHS non-conformances with OHS • Safety Officer, HSR, OHSE
investigation & recording procedures and systems that procedures and systems that consultant/manager, local OHS&E
led to the incident resulted in the hazard committee provide feedback and
assistance with actions;
• OH&S and local OHS&E committee
monitor effectiveness of action;
• Outstanding corrective actions report
monitors completion of
corrective/preventive action.
Inspection & Use, design and Addressing problems Implementing improvements • Results of testing provided to unit/entity;
testing of modification of machinery identified with plant and to plant and equipment and to • Non-conformances reported to safety
machinery & and equipment at Monash equipment and non- systems and procedures that officer, resources manager;
equipment University conformances with test use the plant and equipment. • Plant and equipment placed out of service
Information sheet No. 33 specifications until repaired/undergone maintenance
Inspection, testing, tagging and retesting;
& repair of electrical
• Replaced by equipment with safer design.
equipment
Procedures for isolation of
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Date of first issue: August 2007 Date of last review: November 2010 Date of next review: 2013
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5. Activity Procedure Corrective action Preventive action Requirements
machinery/equipment
OHS document OH&S procedures for Addressing problems Implementing improvements • Procedure for policy/procedure
review document control and identified that require policy to policy documentation to development outlined in Appendix of
retention documentation, legislative prevent system and OH&S procedures for document control
requirements, issues arising procedural non-conformances and retention;
with procedures and systems • Policy, procedures, guidelines reviewed
every 3 years.
Issues raised at Procedures for OHS Addressing individual, system Implementing improvements • Staff and students informed of meetings to
local OHS&E consultation or procedural OHS problems to OHS systems or raise issues;
committee and/or complaints procedures • Issues discussed at local OHS&E
meetings Procedures for OHS issue committee meetings with staff member or
resolution student invited to attend;
Procedures for hazard & • Discussion and resolutions included in
incident reporting, minutes;
investigation & recording • Items remain on agenda until actions
completed;
• OHSE consultant/manager ensures
issues with university wide implications
are referred to OH&S for resolution and
action, if required.
Review of OH&S OH&S consultants and Addressing problems Implementing improvements • Discussion included in meetings;
projects and staff meetings identified at review, taking to OHS projects and plans • Periodic planning meetings to develop
plans action to correct problems in and review progress.
ensuing projects and plans
Management Annual reviews held by Addressing problems Implementing improvements • Discussion and actions required included
review OHS Policy Committee identified at review, taking to OHS projects, plans, policy in minutes;
action to correct problems in documents, systems and • Actions followed up at subsequent
ensuing projects, plans, policy procedures meetings.
documents, systems and
procedures
External and Addressing problems Implementing improvements • Discussion and actions required included
internal reviews identified at review, taking to OHS projects, plans, policy in OHS Policy Committee minutes;
action to correct problems in documents, systems and • Actions incorporated into new projects,
ensuing projects, plans, policy procedures plans, policy documents, systems and
documents, systems and procedures.
procedures • Actions followed up at subsequent
meetings.
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Date of first issue: August 2007 Date of last review: November 2010 Date of next review: 2013
25/10/2010
6. 6. RECORDS
Record to be kept by Records To be kept for:
Academic/administrative Hazard & Incident report forms Indefinitely
unit/
controlled entity
Local OHS&E committee minutes 5 years
Records of audits including: 5 years
• self audits
• internal audits
• external audits
• certification audits
Records of corrective actions taken 5 years
and controls used to address
system or procedural deficiencies
and non conformances
Records of workplace inspections 5 years
OH&S Hazard & incident reports Indefinitely
Policy documentation Indefinitely
OHS Policy Committee minutes Indefinitely
Records of audits including: 5 years
• self audits
• internal audits
• external audits
• certification audits
Records of completed workplace 5 years
inspections
7. REFERENCES
7.1 LEGISLATION
Occupational Health and Safety Act 2004 (Vic)
Occupational Health and Safety Regulations 2007 (Vic)
7.2 AUSTRALIAN STANDARDS
AS/NZS 4801:2001 Occupational Health & Safety Management Systems –
specifications with guidance for use.
OHSAS 18001:2007 Occupational Health & Safety Management Systems –
requirements.
7.3 MONASH UNIVERSITY OHS DOCUMENTS
www.monash.edu.au/ohs/
Monash University self audit questionnaire
Monash University Workplace inspection program
OHS audits at Monash University
OHS monitoring, measurement and registration at Monash University
OHS records management at Monash University
OHSE procedures for document control &retention
Information sheet No. 33 Inspection, testing, tagging & repair of electrical equipment
Procedures for isolation of machinery/equipment
Procedures for hazard & incident reporting, investigation & recording
Procedures for OHS consultation
Procedures for OHS issue resolution
Use, design and modification of machinery and equipment at Monash University
corrective-action.doc, v2 Responsible Officer: Director, OH&S Page 6 of 6
Date of first issue: August 2007 Date of last review: November 2010 Date of next review: 2013
25/10/2010