Risk based approach - Procedures already take a risk-based approach to QMS processes

#1
Hi everyone,

If the company's procedures comply with QSR since they market in the US as well, don't the procedures already take a risk-based approach to QMS processes? I understand that QSR is risk-based or assumed to be risk-based. For example, having a written quality agreement is a risk control measure in the event that the supplier change product specifications.

Please clarify. :thanx:
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#2
Re: Risk based approach - Procedures already take a risk-based approach to QMS proces

snoopy,

It is better to think this way than to develop a separate risk management system or to bolt on a few risk management tools.

Take a look at the opertational processes and their corresponding procedures.

Do the processes have objectives and do they include planning and resourcing to prevent problems in fulfilling the objectives or do they rely on detecting problems in the results?

Lastly, do each of the procedures accurately reflect the measures taken by the its process to prevent nonconformity?

If so, you know that your procedures are assessing and managing operational risks. Make sure your colleagues are up to speed on this logic too.

Bear in mind that the rest of your organization operating as a system and its management system (as documented and undocumented) may need to address other types of risk such as those arising from competitors, the economy, the ‘flu or changing technologies.

John
 

Weeder

Involved In Discussions
#3
Re: Risk based approach - Procedures already take a risk-based approach to QMS proces

Hi Snoopy,

I agree that if you have a system based on the QSR, you already are applying the risk based approach. My question is, how do you convince the editor and what evidence will you show them? Any ideas?
 

Edward Reesor

Trusted Information Resource
#4
Re: Risk based approach - Procedures already take a risk-based approach to QMS proces

My understanding is that the risk must now be quantified or calculated. I am in the process of looking back at all the units we shipped and counted the number of issues related to those units. Its a bit of work and the office staff aren't too happy with me when I ask for those numbers, but I feel that the calculations indicate the true incidence of issues.
 
Thread starter Similar threads Forum Replies Date
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
D Validation of existing equipment - Risk based approach example ISO 13485:2016 - Medical Device Quality Management Systems 3
C Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach IEC 62366 - Medical Device Usability Engineering 1
M Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Medical Device and FDA Regulations and Standards News 0
Pmarszal ISO 19011:2018 - Risk Based Approach for planning, conducting and reporting of internal audits Internal Auditing 8
Q Questions about the Risk-based approach to QMS processes ISO 13485:2016 - Medical Device Quality Management Systems 17
S ISO 13485:2016 - Risk-based Approach ISO 13485:2016 - Medical Device Quality Management Systems 3
S Risk Based Approach for ISO 13485:2016 Form/Procedure ISO 13485:2016 - Medical Device Quality Management Systems 23
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Examples ISO 13485:2016 - Medical Device Quality Management Systems 21
V Evolving QA from 'Compliance-based' to 'Science/Risk-based' approach US Food and Drug Administration (FDA) 2
AnaMariaVR2 Risk Based Approach to Validation [article] Qualification and Validation (including 21 CFR Part 11) 3
C ISO/ PAS 28000 Implementation Guide - I'm interested in its risk based approach Other ISO and International Standards and European Regulations 4
Sidney Vianna Risk Based Audits - Will the industry change it's approach? Registrars and Notified Bodies 0
Scott Catron Any difference in FDA inspections since the risk-based approach was announced? US Food and Drug Administration (FDA) 6
S Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
S Risk based internal auditing Internal Auditing 6
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5
D Requirement of Pharmacovigilance (Drug Safety) Risk Based Strategic and Tactical Audit Plan General Auditing Discussions 0
Ed Panek Are audit non conformances also risk based? ISO 13485:2016 - Medical Device Quality Management Systems 1
P Looking for Risk Assessment Template - Not necessarily Asset based IEC 27001 - Information Security Management Systems (ISMS) 1
S Can anybody share a sample risk assessment prepared based on ISO 17025:2017? ISO 17025 related Discussions 15
E Basic Risk based thinking questions Risk Management Principles and Generic Guidelines 5
Jen Kirley Risk Based Thinking and acts of God/Mother Nature Business Continuity & Resiliency Planning (BCRP) 1
T What is Risk-based Design? ISO 14971 - Medical Device Risk Management 15
Sidney Vianna FAA and DCMA to leverage OASIS data to assist in planning risk-based oversight audits Federal Aviation Administration (FAA) Standards and Requirements 3
Q Risk Based Thinking - Is a Documented Procedure required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Chennaiite But who said we are new to Risk based thinking Imported Legacy Blogs 1
Y Examples of Risk and Opportunities based on ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Is it worth the effort to implement ISO 31000 Risk based on ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Sidney Vianna Are the TC 176 Documents on Risk Based Thinking useful to you? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Informational Risk Management (and Risk Based Thinking) in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 54
J Timeframes for Risk-Based Biocompatibiilty Assessment Other Medical Device Related Standards 3
S Help me with preparing Internal Audit Schedule based on Risk analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Risk Based Inspection: Injection Molding Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
A Risk Based Internal Quality Audit Scheduling and Planning Internal Auditing 2
T Risk based Impact Level related to Customer Complaints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Why do we use Sampling Plans based on Producer's Risk? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 20
RoxaneB Risk-Based Audit Results - Audit Program for Multiple Locations General Auditing Discussions 8
W Customer wants 'Risk Based Compliance' for our Plastic Component Other Medical Device and Orthopedic Related Topics 3
D PA, CA and Risk-Based Decision Making - Need Input Preventive Action and Continuous Improvement 7
C Is Risk Based Decision Making part of Preventive Action Preventive Action and Continuous Improvement 5
Ajit Basrur Risk Based Internal Auditing - Pharmaceutical Plants Internal Auditing 3
J Overall Residual Risk Procedure based on the 2007 version of ISO 14971 ISO 14971 - Medical Device Risk Management 4
S Supplier Risk Check Sheet based on Quality and Delivery needed Supplier Quality Assurance and other Supplier Issues 1
Jen Kirley Some Options for Risk Based Auditing The Reading Room 14
sathis Risk Based Certification General Auditing Discussions 2
C How is risk management handled in a software-based product ISO 13485:2016 - Medical Device Quality Management Systems 1
E Risk Based Audits ocussing on those areas of identified risk General Auditing Discussions 3
E Normal Condition Hazards in Risk Analysis ISO 14971 - Medical Device Risk Management 3

Similar threads

Top Bottom