Escalation Process - IATF 16949 Clause 4.4.1.2

Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
A quick "Bump". My Thanks in advance to anyone who can help.
 

Ajay Akole

Involved In Discussions
#4
As very few of us have the actual IATF document, it would help if the actual text of the requirement was provided.
4.4.1.2 Product Safety
h) defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification;
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
From what I gather, "escalation process" in this section deals with the need to react and bring to the attention of management (and potentially customers) when a concern exists over product integrity.

E.g., the heat treatment furnace might have malfunctioned and we are unsure about the mechanical properties of the brake discs we just processed there, a flag should be raised. Along the lines of "if you know/suspect something is wrong (with the product), say something (to a designated higher up).
 
M

Marioalberto83

#6
From what I gather, "escalation process" in this section deals with the need to react and bring to the attention of management (and potentially customers) when a concern exists over product integrity.
Good afternoon

I am having a tough time with this, I have not found any definition where "escalation process" implies that it is related to a "concern on the product"; I think it sounds obvious, however I think "escalation process" could have other applications, I think the standard is not clear on this. Do you have any assumption that helps support the applicability provided by Sidney?

Regards
 
M

Marioalberto83

#8
Since the section of the standard deals with product safety, what other applications do you have in mind?
Management of product-safety includes: identification of requirements, notifications, special approvals, identification of characteristics, controls at the point of manufacturing and so on.

So I think the standard is not specific in which sense escalation process should apply, it could apply for the approvals, addressing processes out of control, reaction plans or as you said product integrity concerns.

I agree with your approach, however it is not quite straightforward to me.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
In auto-speak in general, "escalation" is any time a process defined a time period in which an action was supposed to be taken and wasn't, or wasn't completed. The issue would be "escalated" to a higher management level to force action. YMMV
 
M

Marioalberto83

#10
In auto-speak in general, "escalation" is any time a process defined a time period in which an action was supposed to be taken and wasn't, or wasn't completed
I agree with you Marc, and also agree with Sidney, I think an escalation process relevant to product safety could be for example: a) when a problem is not address/solved on time, b) when a problem needs to be handled by upper levels personnel, c) could be other approaches.

I think the company is able to define the escalation approach which makes better sense for the product.

I take the opportunity to thank you guys since your feedback has been decisive for my professional growth :)

Best Regards
 
Thread starter Similar threads Forum Replies Date
C IATF 16949 - Product Safety Escalation Process Timeliness IATF 16949 - Automotive Quality Systems Standard 8
B Implementing an Escalation Process and Andon system Supplier Quality Assurance and other Supplier Issues 1
P Escalation Process in Project Management Misc. Quality Assurance and Business Systems Related Topics 10
S Escalation Process, Responsibilities and Matrix Document Control Systems, Procedures, Forms and Templates 8
Tagin Evaluating nonconformances for escalation using Bayesian methods? Statistical Analysis Tools, Techniques and SPC 2
P Notify Registrar of Escalation letter IATF 16949 - Automotive Quality Systems Standard 1
sutie What is Ethics Escalation (“Whistle-Blowing”) Policy - Corporate Responsibility IATF 16949 - Automotive Quality Systems Standard 7
A Escalation to CAPA - Assessing if an NC warrants a CAPA Nonconformance and Corrective Action 4
J Escalation of an External Audit Nonconformance Nonconformance and Corrective Action 13
C Internal Audit Concerns including Escalation of Non-Conformances General Auditing Discussions 6
M Escalation methods - Having to go over someone's head to address an issue Nonconformance and Corrective Action 6
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 7
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
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Error Proofing Label process Manufacturing and Related Processes 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 5
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 6
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 3

Similar threads

Top Bottom