Process for Product Safety - Ideas for Documenting Process for 4.4.1.2

G

greatlakesgirl

I am looking for ideas for documenting Process for 4.4.1.2? I am new to this, help please!
 

Peters

Quite Involved in Discussions
Re: Process for Product Safety?

I am looking for ideas for documenting Process for 4.4.1.2? I am new to this, help please!

A.It could be elements of some different documents/procedures for (e.g.):
1.project planning/design and product/process design
2.purchasing
3.production process control
4.identification and traceability
5.product inspection
6.service activities
7.changes control
8.customer authorization
9.personnel training
10.records retention

OR

B.It could be contained in one document/procedure
 

Sidney Vianna

Post Responsibly
Leader
Admin
Re: Process for Product Safety?

Despite being developed for another Industry, altogether, the material contained in the IAQG SCMH concerning product safety might be of interest to folks involved with the IATF 16949 standard. Attached an awareness presentation on product safety.
 

Attachments

  • 3_9_2_Product_Safety_Awareness_26DEC2016.pdf
    600.9 KB · Views: 2,451
Thread starter Similar threads Forum Replies Date
C IATF 16949 - Product Safety Escalation Process Timeliness IATF 16949 - Automotive Quality Systems Standard 8
T New process capability analysis required when changing a product on the same line? IATF 16949 - Automotive Quality Systems Standard 6
A Cosmetic product registration process EU Medical Device Regulations 0
C Product compliance process REACH and RoHS Conversations 10
M Process Flow of ECN Product User and Service Guides Process Maps, Process Mapping and Turtle Diagrams 1
S Combo Product Assembly Process OQ Qualification and Validation (including 21 CFR Part 11) 0
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
M Process & Product Characteristic in Control Plan FMEA and Control Plans 17
L Product and process Deviation procedure Manufacturing and Related Processes 1
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
W Core Process Metrics AS9100D for Product Planning? Quotes and sales? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I Corrective Action Tracking for Product and Process in the same system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Sidney Vianna AS9100 News PPAP in the Aerospace Sector - What is it? AS9145 - Requirements for Advanced Product Quality Planning and Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
V IATF 16949 Manufacturing Process & Product Audits IATF 16949 - Automotive Quality Systems Standard 1
I Process compressed air and contact with the product (ISO 8573-1:2010) Qualification and Validation (including 21 CFR Part 11) 0
M IATF 16949 - Cl. 8.3.3 - Product design inputs, manufacturing process design inputs IATF 16949 - Automotive Quality Systems Standard 4
V For a Drug-Device Combination Product, 'Design Control' Process is triggered at? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I FDA Exempts Product Codes from 510(k) Process (Class II Medical Devices) US Food and Drug Administration (FDA) 0
V Product Development - When to start calculating Process Capability Capability, Accuracy and Stability - Processes, Machines, etc. 3
M Compliance with IATF 16949 Clause 8.3.4.4 Product Approval Process IATF 16949 - Automotive Quality Systems Standard 2
L Return of Product Process - Procedure or Flowchart Misc. Quality Assurance and Business Systems Related Topics 14
R Testing a Product Recall Process IEC 27001 - Information Security Management Systems (ISMS) 8
P May I combine the Process Audit and Product Audit into Delphi's LSR? Customer and Company Specific Requirements 3
K Auditing New Product Introduction Process General Auditing Discussions 21
L Medical Device New Product Design & Development- How long does this process take you? Other Medical Device and Orthopedic Related Topics 1
B ISO 9001: Question on Process Performance and Product Conformity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G ISO 14001 & Product Design Process Environmental Aspect Review Requirements ISO 14001:2015 Specific Discussions 7
J Should I have Process or Product Focus in PFMEA? FMEA and Control Plans 3
V Examples of Design and Process FMEA for Pharmaceutical Product Development ISO 14971 - Medical Device Risk Management 7
Q Identifying Critical Items and Key Characteristics - Product Realization Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
T Process Validation, NPD (New Product Development), and Supplier Management Qualification and Validation (including 21 CFR Part 11) 7
S Product FMEA vs. Process FMEA - Aerospace Industry Machine Shop FMEA and Control Plans 5
somashekar Can Process Deviation be handled under control of Nonconforming Product? ISO 13485:2016 - Medical Device Quality Management Systems 2
S What are your thoughts on Process vs Product Control Plans ? FMEA and Control Plans 3
G ISO 13485 Requirement on labeling product in WIP (Work In Process) ISO 13485:2016 - Medical Device Quality Management Systems 4
J Product and Process Audit according to ISO/TS 16949:2009 Process Audits and Layered Process Audits 9
J Introducing a new Product Variant - ECO Process? Document Control Systems, Procedures, Forms and Templates 3
T Requirement for a Documented Process for the Review and Release of Product For Sale ISO 13485:2016 - Medical Device Quality Management Systems 6
Q AS9100 Clause 8.3 - Control of Nonconforming Product Process for Approving Personnel AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
L Supply Chain and Product Creation Process Improvement Quality Tools, Improvement and Analysis 1
B Product Realisation Process Map - Need some help, please review and comment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V Common Failure Modes for a Product/Process Line ISO 14971 - Medical Device Risk Management 1
D How to determine Equipment Tolerance Variation - Product vs. Process Tolerance General Measurement Device and Calibration Topics 7
V Defining Quality Assurance's Role in R&D (Product and Process Development) Design and Development of Products and Processes 11

Similar threads

Top Bottom