Deleting Risks if a particular Risk has been Eliminated

V

Visal

#1
#1
Dear All,

If a particular risk has been eliminated, Can it be deleted from a risk charter?

Specifics: Talking in terms of a software bug which was eliminated in the new version.

Thanks
 
Paper to QMS ad
Elsmar Forum Sponsor
Bev D

Bev D

Heretical Statistician
Staff member
Super Moderator
#2
#2
can you elaborate on what you mean by a risk charter and 'deleting'?

in general you 'retire' a risk through mitigation and state in you documentation that the failure mode has been eliminated but you maintain the historical record of it's existence and what you did about it.
 
M

Marcelo

Inactive Registered Visitor
#3
#3
If a particular risk has been eliminated, Can it be deleted from a risk charter?
Click to expand...
No, it's a good practice to keep every identified and controlled risk. For example, if you change the device or software afterwards, you are required to verify if there's any new risks or if already controlled risks were modified (it may be the case the the original controlled risk is not controlled anymore).
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Problem with deleting vendors in Visual Manufacturing Quality Assurance and Compliance Software Tools and Solutions 7
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 11
T Risks arising from control measures vs. ineffective control measures ISO 14971 - Medical Device Risk Management 7
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 4
Robert Stanley I'm @ RISK of not showing my RISKS! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
Richard Regalado Top 10 operational risks of 2019 for business continuity planning Business Continuity & Resiliency Planning (BCRP) 6
A Managing overseas travel risks to food handlers Food Safety - ISO 22000, HACCP (21 CFR 120) 3
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
Jacquie Collins 6 Risks and Opportunities ISO 14001:2015 ISO 14001:2015 Specific Discussions 6
D How to Identify the Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Are Risks and Opportunities Required as Part of the Process Definition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
M Informational How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier Medical Device and FDA Regulations and Standards News 0
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
M FDA News Safety Alert – USFDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation Medical Device and FDA Regulations and Standards News 0
B ISO 17025 8.5 Actions to address risks and opportunities ISO 17025 related Discussions 7
A Risks and Opportunities associated to Legal Compliance - 6.1.3 ISO 14001:2015 Specific Discussions 4
O Examples of the external and internal issues and their risks and opportunities IATF 16949 - Automotive Quality Systems Standard 2
A Risks related to Method Validation and Stability Studies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
qualprod ISO 9001 Risk control method - What could be the better way to control risks? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Redundancy between Process risks and Process Performance indicators ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Risks and opportunities that could be associated with the purchasing department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q ISO 14001:2015 Clause 6.1: Actions to address Risks & Opportunities ISO 14001:2015 Specific Discussions 2
Sidney Vianna Guidance on Management of Psychosocial Risks in the Workplace Occupational Health & Safety Management Standards 5
H Depth in the organization for Interested Parties and Risks & Opportunities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
Q ISO 9001:2015 - Clarification in 6.1.2 Note 1 (Options to Address Risks) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Practical guide to scan for Risks in all QMS systems without missing any ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Q Risks Examples in Top Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O How will you handle Clause 6.1 - Risks and Opportunities for AS9100 Rev. D Auditors? Risk Management Principles and Generic Guidelines 22
Q SWOT Outputs - Risks, Opportunities and Improvements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Source of practice to Evaluate Risks? (ISO 9001:2015) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Opportunities only derived from Risks? Detecting Risk & Opportunities in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Does KPI for Processes need to be correlated with the specific Risks for Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Actions To Address Risks and Opportunities IATF 16949 - Automotive Quality Systems Standard 1
W Chinese Authorized Representative - What are the regulatory risks? China Medical Device Regulations 3
M Informational Is Identification of Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 96
A Informational Confusion about Risks for Processes in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44
R OHSAS 18001:2007 Section 3 - Controlling Work Place Risks Occupational Health & Safety Management Standards 3
D Biological and Chemical Risks to the user in the Hazard Analysis ISO 14971 - Medical Device Risk Management 1
C Risks involved in requesting Cert to ISO9001:2015 right when released ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Risks to Health - Patient and Clinician ISO 14971 - Medical Device Risk Management 4
Marc The Risks of Generic Drugs Coffee Break and Water Cooler Discussions 24
Ajit Basrur FDA issues Guidance Document - Benefits-Risks Factors to consider for 510(K) US Food and Drug Administration (FDA) 1
x-files [QMS] Identification and Evaluation of Aspects, Impacts and Risks... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom