4.2.3.4 Product Safety - What does this element want? I find it very ambiguous

B

Beskem

#1
#1
What does this element want? I find it very ambiguous.

Due care and product safety shall be considered in...design control...process control policies and practices
The supplier should promote internal awareness of safety considerations relative to the supplier's product.

1. Are we talking about the the care and safety of the part being produced for the customer?
2. Are we talking about the care and safety of the employees making the part, where they might be injured as a result of poor design control and /or process control policies and practices.
3. Are we talking about due care and product safety in regard to protecting the customer's employees from injury (e.g. cuts from excessive burrs on parts)
4. Are we talking about due care and product safety as it relates to destructive and nondestructive testing of parts to insure the final customer receives the design intended safety performance.


------------------
:)
 
Elsmar Forum Sponsor
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
#2
An extreme example might be air bags.

Designers should be able to show they considered passenger safety as well as transportation safety (manufacturer to auto assembly plant - handling, storage, preservatione, etc.) You are seeing this issue with air bags and people being killed by a device designed to protect them. Safety considerations in their design are much different than they were 10 years ago.

Process engineers should be able to discuss what is does to ensure employee safety during manufacture / assembly. An example of this is, because of the sodium azide used, is process equipment design (including the design of the actual assembly room). If one of those babys go off 'accidentially', what will happen to the employee(s) in the assembly area?

Yes - it's ambiguous. Remember that some of the requirements require a school like answer. "Tell me about how you...."
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Product Safety Responsibility - Job shop such as a machine shop AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
S VW Supplier Product Safety Representative (PSB) upgrade to PSCR VDA Standards - Germany's Automotive Standards 0
C Safety lettering on a product CE Marking (Conformité Européene) / CB Scheme 5
M EMC Directive and product safety standards CE Marking (Conformité Européene) / CB Scheme 1
M Informational Design for new product safety marking for the no-deal Brexit scenario Medical Device and FDA Regulations and Standards News 1
L IATF 16949 requirements for Product Safety Procedures IATF 16949 - Automotive Quality Systems Standard 14
M IATF 16949 - Who should be assigned as the Product Safety Officer? IATF 16949 - Automotive Quality Systems Standard 3
C IATF 16949 - Product Safety Escalation Process Timeliness IATF 16949 - Automotive Quality Systems Standard 8
A AS9100 Rev D - Procedure for Product Safety & Control of Counterfeit Part (Format) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
J IATF 16949 Product Safety IATF 16949 - Automotive Quality Systems Standard 13
Q IATF 16949 Cl. 4.4.1.2 - Product Safety - How to interpret IATF 16949 - Automotive Quality Systems Standard 13
A VW Supplier Product Safety Representative (PSB) Responsibilities and Requirements VDA Standards - Germany's Automotive Standards 4
R How to make sense of IATF 16949 Product Safety IATF 16949 - Automotive Quality Systems Standard 1
M IATF 16949 Clause 4.4.1.2 - Product Safety - Concept of the Title IATF 16949 - Automotive Quality Systems Standard 4
G Process for Product Safety - Ideas for Documenting Process for 4.4.1.2 IATF 16949 - Automotive Quality Systems Standard 3
M Exclusion of IATF 16949 Clause 4.4.1.2 - Product Safety IATF 16949 - Automotive Quality Systems Standard 2
D Product Safety in AS9100D Clause 8.1.3 - Hazards Analysis AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 18
M IATF 16949 Clause 4.4.1.2 - Product Safety IATF 16949 - Automotive Quality Systems Standard 13
A Can someone provide an example of a Product Safety Policy? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
L Product Safety Officer - How to keep VW Happy VDA Standards - Germany's Automotive Standards 24
V VAG Customer Specific Requirements - Product Safety Responsibility Customer and Company Specific Requirements 1
S Searching for a Lab to test Patient Safety for Product used in Mouth CE Marking (Conformité Européene) / CB Scheme 2
S AS9110B ? Product Safety Inputs to Management Review AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
6 Catering HACCP/Food Safety - Traceability from Receipt to Finished Product Food Safety - ISO 22000, HACCP (21 CFR 120) 1
M Combining EcoDesign with Compliance (Product Safety/EMC) Engineer Career and Occupation Discussions 2
C Product Safety Control example procedure wanted Document Control Systems, Procedures, Forms and Templates 4
somashekar Product audit for using the safety mark (ETL) on label Other Medical Device and Orthopedic Related Topics 2
Hershal Product Safety Testing - Interested in safe products? Misc. Quality Assurance and Business Systems Related Topics 2
Icy Mountain Personnel safety to achieve product quality - TS16949 Section 6.4.1 IATF 16949 - Automotive Quality Systems Standard 2
M 7.2.1.c Product requirements - Determining product, enviroment, health, safety, etc IATF 16949 - Automotive Quality Systems Standard 4
S Personnel safety to achieve product quality as required by TS 16949 Clause 6.4.1 IATF 16949 - Automotive Quality Systems Standard 4
Y New Japanese EMC/electrical safety standards - Additional product testing required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Product Safety - Damage or hurt to our or Client's Installations or Employees QS-9000 - American Automotive Manufacturers Standard 6
D Product Safety - 4.2.3.4 - Safety considerations relative to the supplier's product? QS-9000 - American Automotive Manufacturers Standard 2
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
D Interesting Discussion Requirements for selling a Food product in USA Food Safety - ISO 22000, HACCP (21 CFR 120) 0
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
M Definition of Done - New Product Phase to the sustaining phase Manufacturing and Related Processes 3
Miner Quality checks of product QR codes FMEA and Control Plans 2
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
G Handling Unpacked (Additive Chemical) Product For Automotive Applications IATF 16949 - Automotive Quality Systems Standard 3
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
T Modification of a product on the market EU Medical Device Regulations 2
D CE Marked product considered a Drug in India Other Medical Device Regulations World-Wide 0
K Product (Device) Life cycle - Product Life AFTER the Post Market Phase Medical Device and FDA Regulations and Standards News 3
Ajit Basrur Physical Address on Product Labels (EU MDR perspective) EU Medical Device Regulations 2
S How do you record your Nonconforming product? Batch production of staged processes Nonconformance and Corrective Action 2
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Similar threads
Top Bottom