What is the importance of a Risk Register?

v9991

Trusted Information Resource
#1
we have to implement, risk management with a group of people working on development of products. (pharma domain.)
we figured out the various aspects of QRM (using the concepts of Quality by Design and FMEA as a main tool)
what is the importance of risk register. ( how is it used....compliance and also to manage the risk across the unit/organization / product?)
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
The risk register has so much in common with the FMEA that I would have guessed the FMEA could work for this need unless customers and regulators disagree. If they did because they expected to see a certain format, I would apply the FMEA principles of FMEA but hide or move the columns they don't want to see.

In both cases the importance is what is gained from both a thoughtful, comprehensive analysis and effective actions taken to reduce the risks. Like physical exercise, we get out of it what we put into it.
 

Kales Veggie

People: The Vital Few
#3
we have to implement, risk management with a group of people working on development of products. (pharma domain.)
we figured out the various aspects of QRM (using the concepts of Quality by Design and FMEA as a main tool)
what is the importance of risk register. ( how is it used....compliance and also to manage the risk across the unit/organization / product?)
In one sentence:

- to prioritize, to rank, to mitigate, to track status of the identified risks with available resource (time, people, money, effort)
 
K

kgott

#4
we have to implement, risk management with a group of people working on development of products. (pharma domain.)
we figured out the various aspects of QRM (using the concepts of Quality by Design and FMEA as a main tool)
what is the importance of risk register. ( how is it used....compliance and also to manage the risk across the unit/organization / product?)
A risk register can be implied in 4.3.1 Hazard identification of ASOHS 18001. Its also one of those things that become common, industry accepted, then unoffically required and then with enough time, become mandatory.

Because a risk register is enshrined in legislation in Australia, they are common here and have spilled over into non-mining safety as well.

They are useful in that they become an aggregate list of hazards and controls and make doing a JHA (or JSA) easier in the organisation.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
M Kano-model and Importance Benchmarking 1
R Customer Satisfaction importance in companies with Government/Public Administration as main customer? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R How to SHOW the importance of checklists, through some team gaming or play? Training - Internal, External, Online and Distance Learning 37
M Informational The USFDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
C Document Hierarchy Importance? IATF 16949 - Automotive Quality Systems Standard 4
R Importance of Written Procedures in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P How to Scientifically Prove the Importance of a Process - CMMI Process Areas Software Quality Assurance 7
P Total Variation in Data - Overall Importance of the Principal Components Reliability Analysis - Predictions, Testing and Standards 1
W Determining the Status and Importance of the Processes and Areas to be Audited Internal Auditing 7
C Importance of Documenting NCP's and CA/PA's ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
P Importance of Calibration Traceability to the SI General Measurement Device and Calibration Topics 1
T Internal Audit - How to define the Importance of Departments and Processes Internal Auditing 8
K Importance of Medical Device Accessory Design Controls Other US Medical Device Regulations 4
shimonv The importance of NRTL Approval - Electronic Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M How to combine the Importance Performance Matrix and the KANO Model? Benchmarking 8
S The Importance of Inspector Traceability during the Inspection Process Misc. Quality Assurance and Business Systems Related Topics 9
K Staff Awareness of the Importance of their Activities - ISO 9001 Clause 6.2.2d Quality Manager and Management Related Issues 11
V Importance of Replicate Trials/Measurements in DOE Trials Statistical Analysis Tools, Techniques and SPC 2
V Defining Subgroups and Importance of Subgroups in SPC and Process Capability Statistical Analysis Tools, Techniques and SPC 6
M Team Work Exercise examples to illustrate the importance of Team Work Training - Internal, External, Online and Distance Learning 1
M World Quality Day - Importance of Quality Quality Assurance and Compliance Software Tools and Solutions 1
F Importance of Complete Inspection Records in Aerospace Manufacturing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M The importance of Document Control? How do you handle your Document Control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Importance of Polarized Light for PWB/PCB Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
ScottK The Importance of the Date Format on your Registration Certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Why Cpk 1.67 and Importance of Cp? Statistical Analysis Tools, Techniques and SPC 12
V The Importance of Health and Safety vs. Quality Management Quality Manager and Management Related Issues 18
C Corrective Action Importance Level - Cost and Quality - The Johari window Nonconformance and Corrective Action 4
8 SMED Classroom Exercise to show operators the importance of SMED Lean in Manufacturing and Service Industries 10
F Cl 8.2.2 on Internal audit - Interpretation of Status and Importance General Auditing Discussions 4
BradM ISO 17025: Importance of Reporting Tolerances ISO 17025 related Discussions 16
L Practical Ideas for TS 6.2.2.4 - Personel are aware of the relevance and importance.. Training - Internal, External, Online and Distance Learning 5
Marc Discussion Thread Titles and Post Titles - Importance of Titling and Title Changes Elsmar Cove Forum ToS and Forum Policies 9
U The Importance of Correct Sample Size Calculation - Greek Alphabet Soup Book, Video, Blog and Web Site Reviews and Recommendations 7
D What is "Aware of the Importance"? ISO14001 clause 4.4.2 Miscellaneous Environmental Standards and EMS Related Discussions 21
Marc The Importance of Maintenance World News 3
T ELV and IMDS Questions - Reporting Services and Importance to Suppliers RoHS, REACH, ELV, IMDS and Restricted Substances 7
U Communicating to the company the IMPORTANCE of meeting customer requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Quality Objectives - How would we teach the importance of QMS? Training - Internal, External, Online and Distance Learning 9
Antonio Vieira The importance of some processes... Internal Audit, Management Review, Nonconformance Management Review Meetings and related Processes 3
L 8.2.7 Internal Audit Interpretation - Defining Status and Importance Internal Auditing 18
D Discussion: Importance of a QMS (Quality Management System) Other ISO and International Standards and European Regulations 11
G Importance and Impact of NonConformity - QA Costs and Liability Nonconformance and Corrective Action 23
Claes Gefvenberg 8.2.2 - Opinions please... Audit schedule based on importance and 'status' General Auditing Discussions 17
A Scheduling Internal Audits: Status and Importance of the Activity Internal Auditing 4
F Scheduling Internal Audits - What is meant by 'based on status and importance'? Internal Auditing 35
T As Appropriate -and- Shall - The importance of verbiage QS-9000 - American Automotive Manufacturers Standard 7
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
Q FMEA and Risk assessment in MS ACCESS FMEA and Control Plans 2
I Realization processes input into overall risk ISO 14971 - Medical Device Risk Management 2

Similar threads

Top Bottom