Tools for Risk - ISO 9001:2015 - Suggestions

Q

QAMTY

Hello everyone

Please advise on the next point.

Im trying to comply with 6.1 in 9001 2015 (risks) and I´m trying to use
ISO 31010 as a reference.
Additionally I have seen information on the web, where it is mentioned that for complying to the risk assessment for 9001, it could be used a fishbone tool (cause and effect analysis) for it.

However in table A-1, page 22, the level of risk, probability, consequence and risk evaluation , is stated that cause and effect analysis is not Applicable N/A. Compared against SWIFT, where everything apply (S/A).

In your opinion, and complying with 9001 2015, what tool is it recommended?

My business is a print shop, really no big risks around me

Please feedback on this matter.

Thanks
 
D

DRAMMAN

If you are already ISO901:2008 certified try talking to your auditor or CB to see if they have any recommendations. or what they are seeing at other clients.

FMEA's are great tools. Try researching project risk analysis for other ideas.

Obviously, we all want to pass the audit buy try not to make that your sole focus. I am sure documenting potential risks and how you are managing that risk will make you a better company by simply going through the process.

My assumption is that auditors can not reject any documentation as not good enough since they offer no requirement beyond documented information. As along as you can demonstrate you use RBT in managing your business and have some documented information to support that then you are golden.

Questions may arise if your risk analysis is very weak or not very relevant to the QMS. As an example, lets say your only identified risks are very minor details such as the risk of your garbage bags breaking. A better example of risk based thinking would be as follows.

Risk: My sole ink supplier goes out of business leaving me unable to deliver orders.

Counter measure: We identified 2 back up supplier, verified their offerings meet our needs, and give them some business so a relationship is established.

There is no requirement to rank risks or use more elaborate methods.

Then as part of your RBT process your team reviews the risk list and countermeasures every year.
 
D

DRAMMAN

There are several RBT books and classes available now if you really want to learn more. I am sure the consultants are hard at work as I speak creating more.
 
D

dsanabria

Quite Involved in Discussions
QAMTY said:
... Im trying to comply with 6.1 in 9001 2015 (risks) and I´m trying to use
ISO 31010 as a reference.
Additionally I have seen information on the web, where it is mentioned that for complying to the risk assessment for 9001, it could be used a fishbone tool (cause and effect analysis) for it.

However in table A-1, page 22, the level of risk, probability, consequence and risk evaluation , is stated that cause and effect analysis is not Applicable N/A. Compared against SWIFT, where everything apply (S/A).

In your opinion, and complying with 9001 2015, what tool is it recommended?

My business is a print shop, really no big risks around me

Please feedback on this matter. ...
Click to expand...

This is what the aerospace uses as guidance - hope it helps.
.
 

Attachments

  • 7.3.2_Risk_Management_Storyboard_Content_01_APR_2014(1).pdf
    1.3 MB · Views: 1,178
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Q Risk Tools in ISO 31010 - Root Cause Analysis vs. Cause-and-effect Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Risk Assessment Tools ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R FOD Risk Assessment - What tools would you recommend for assessing FOD risk? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Good training courses covering Risk Management Tools Training - Internal, External, Online and Distance Learning 4
SANTHSH Consumables, Paints, End-covers, NDE Chemicals & Tools suppliers classification and evaluation Oil and Gas Industry Standards and Regulations 6
Z GRR for multiple automated metrology tools Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
G Automated Workflow Tools ISO 13485:2016 - Medical Device Quality Management Systems 4
R Tools used for measuring (New to metrology) General Measurement Device and Calibration Topics 9
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Informational Shainin - Books, Tools & Teq Book, Video, Blog and Web Site Reviews and Recommendations 2
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Bev D MSA Tools Misc. Quality Assurance and Business Systems Related Topics 3
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
adir88 Tools for Normal and Fault Conditions ISO 14971 - Medical Device Risk Management 9
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
M Defining frequency of measurement tools callibration Calibration and Metrology Software and Hardware 3
F How do you add accuracies for tools with different measurement devices? General Measurement Device and Calibration Topics 1
B Seven Basic Quality Tools (January 23) [Paid] Training - Internal, External, Online and Distance Learning 1
K PCI DSS - MS Paint and other screenshot tools Other ISO and International Standards and European Regulations 0
DuncanGibbons Are there aerospace standards for the development and manufacture of euipment and tools? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
G ISO 9001 and ISO 17025 - Measuring tools not in calibration system General Measurement Device and Calibration Topics 3
S Tools and equipment provided by customer - Considered as external provider? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S I have just purchased the all new Core Tools Software (CTS) from AIAG IATF 16949 - Automotive Quality Systems Standard 39
M Informational FDA Qualifies First Biomarker Test as Part of Medical Device Development Tools (MDDT) Program Medical Device and FDA Regulations and Standards News 0
A Statistic Tools to Know Capability of Sealing Machine for Seal Width Capability, Accuracy and Stability - Processes, Machines, etc. 3
M Interesting Discussion Surface Cleanliness Real Time Test Tools General Measurement Device and Calibration Topics 2
R Unsecured pedestal mounted tools, oh my! Human Factors and Ergonomics in Engineering 11
H Evaluate Contingency Plan for Equipment and Tools IATF 16949 - Automotive Quality Systems Standard 4
I Tool maintenance and calibration procedure - Calibrating tools/equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
O Storage of Calibrated Tools General Measurement Device and Calibration Topics 12
S Reference calibration tools (traceable to NIST) that are not used in production ISO 13485:2016 - Medical Device Quality Management Systems 4
L Radius Measuring Tools General Measurement Device and Calibration Topics 4
Q Analyzing Process Bottlenecks Tools ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Y Differences between the Classic 7 QC Tools and New QC Tools Quality Tools, Improvement and Analysis 3
J Pneumatic & Electrical Torque Tool - Calibration/Verification of 'Power Tools' General Measurement Device and Calibration Topics 3
B Kaizen Event - Which tools to use? Lean in Manufacturing and Service Industries 8
I What are considered next generation ITSM tools? IT (Information Technology) Service Management 2
S AS9100C 8.2.2 - Selected Tools & Effectiveness of IA Process and Performance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Cleaning validation for Molding Tools? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
G FRACAS Tools Problem Solving, Root Cause Fault and Failure Analysis 1
A What are methods and tools to measure Workload analysis ? Human Factors and Ergonomics in Engineering 1
P IT tools for Knowledge Sharing in a large Organization Misc. Quality Assurance and Business Systems Related Topics 1
T Tools Six Sigma for my Automated Machine Six Sigma 8
O Lean Tools in Labour Intensive Manual Manufacturing Lean in Manufacturing and Service Industries 20
D Contact Retention Tools Question General Measurement Device and Calibration Topics 3
E Methods in Measuring Angles or Checking Angles for tools? General Measurement Device and Calibration Topics 10
A Calibration of Non-Measurement Tools (e.g.: Hydraulic Jacks) Capability, Accuracy and Stability - Processes, Machines, etc. 5
sagai New Draft Guidance for Medical Device Development Tools Other US Medical Device Regulations 3

Similar threads

Top Bottom