SBS - The best value in QMS software

Process Risk Assessment Example for a Manufacturing Company

B

blackbeard

#1
We should have a product hazard and risk assessement for each of our product or products group.

Does anyone have one who could share with me?

We are a manufacturing company.

thanks for your help
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
What industry do you work in? Some will expect a risk analysis of some sort for every product or product group, but ISO 9001 has no "shall" for that.
 
B

blackbeard

#3
We pack clays for Industrial spillages and cat litter, the clays are delivered as is, we do add some fragrance to some products.
We add the clays to hoppers/silos and fill bags. We have different clays but the process is the same, so I guess we could do two groups? Fragranced and No Fragrance?
 
Thread starter Similar threads Forum Replies Date
J Simple supplier evaluation qualification process form that includes Risk Assessment Document Control Systems, Procedures, Forms and Templates 2
M Risk Identification and Risk Assessment for any Process - Is it necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
P Risk Assessment Production Process Milling for Implantable Joints EU Medical Device Regulations 2
D Risk Assessment - Problem Management Process - Seeking Model/Example Software Quality Assurance 1
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
Jimmy123 Process disturbances and the repair - How do you handle this risk in your company? FMEA and Control Plans 18
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
J Differences between a Risk Management Plan vs. Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Q Risk Management - Additional Process in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Is PFMEA (Process FMEA) for OEM sufficient to address Risk? ISO 13485:2016 - Medical Device Quality Management Systems 7
A Is Risk Identification and Treatment a Process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
A Is Risk Management Process compliant to ISO 14971 in absence of Hazardous Situations? ISO 14971 - Medical Device Risk Management 5
L GHTF/SG3/N15R8 - Process Validation and Risk Analysis ISO 13485:2016 - Medical Device Quality Management Systems 4
M Streamlined Risk Management Process - Focus on Compliance with Standards ISO 14971 - Medical Device Risk Management 5
M Auditor Sued for Damages, for Failure to Warn of Process Risk Misc. Quality Assurance and Business Systems Related Topics 32
V Common Errors while Implementing Risk Management Process ISO 14971 - Medical Device Risk Management 9
S Do HF Accessories need to perform a Risk Management Process of 60601-1:2005? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Methods for doing Production Process Risk Analysis ISO 14971 - Medical Device Risk Management 4
M Risk Analysis using FMEA Process Flow Chart - Health Care Information System FMEA and Control Plans 6
L ISO13485 Cl. 7.1 Process Flow (Product Realization & Risk Management requirements)? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Who should "own" the Risk Management Process? ISO 14971 - Medical Device Risk Management 5
S KPIs (Key Performance Indicators) and Risk Management Process (ISO14971:2007) ISO 14971 - Medical Device Risk Management 5
B What to include in a "Risk management/FMEA" process FMEA and Control Plans 3
M Include Risk of Rework in a PFMEA (Process FMEA)? FMEA and Control Plans 5
M Contract Review Process - Risk Analysis - 7.2.2.2 Manufacturing feasibility Contract Review Process 4
M Risk Management Process Workbook - Attached Files FMEA and Control Plans 28
C In-process inspection - Tooling and assembly lines for automotive companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Efficacy of an IT process after a cyber attack ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
N Riveting - special process Manufacturing and Related Processes 11
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 5
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 12
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
S Approval Process for Disinfectant Sanitizers in Dubai Elsmar Xenforo Forum Software Instructions and Help 0
D Measurables for Plastic Injection molding process Manufacturing and Related Processes 1
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
R Inspection and Work order process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
A How to reduce the process SPC monitoring Capability, Accuracy and Stability - Processes, Machines, etc. 3
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Two excellent examples of process capability analysis from Quality Magazine Capability, Accuracy and Stability - Processes, Machines, etc. 5
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9

Similar threads

Top Bottom