Documenting Processes requiring Customer Notification

O

ogghall

Starting to get Involved
Some of our customers are requiring notification when processes are changed. We have numerous locations providing product to those certain customers. These numerous locations make similar products so process are similar but not identical. The processes in these locations are not unique to the products we supply to customers requiring the notification. What I am looking for are examples how it is internally documented that if one these processes is changed at a location that we need to notify the customer.

Thanks in advance for any examples that can be provided
 
N

NikkiQSM

Quite Involved in Discussions
ogghall said:
Some of our customers are requiring notification when processes are changed. We have numerous locations providing product to those certain customers. These numerous locations make similar products so process are similar but not identical. The processes in these locations are not unique to the products we supply to customers requiring the notification. What I am looking for are examples how it is internally documented that if one these processes is changed at a location that we need to notify the customer.

Thanks in advance for any examples that can be provided
Click to expand...

The customers I deal with are mainly medical. If we even move a machine 6 feet we need to alert the customer. We are actually required to alert the customer of any changes 30 days BEFORE it happens.

What is the product you produce? Is it medical?

I would simply come up with a document that outlines what is considered a "process change" and then provide instructions how to alert the customer and the steps that must be taken before the process is changed.

Train R&D and Customer Service to this document.

Save the document and proof that the notification was sent out, and that should take care of it :)

:2cents:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Documenting Processes such as Receiving Inspection, and Auditing to Turtle Diagrams Process Maps, Process Mapping and Turtle Diagrams 20
Q Documenting Effectiveness of Training Training - Internal, External, Online and Distance Learning 14
L Documenting internal audit of customer specific requirements IATF 16949 - Automotive Quality Systems Standard 11
C 21 CFR 820.90 - Documenting rework and reevaluation in DHR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
T Documenting hazardous situations associated with user/patient population ISO 14971 - Medical Device Risk Management 3
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
J Documenting a Calibration Interval Extension Calibration Frequency (Interval) 7
B Documenting hardware on Form 2 of AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
bryan willemot Documenting past problem history for fasteners for AS9100 Rev D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q Documenting Customer Complaints (Records) Customer Complaints 6
R Documenting Expiration Date Extension for a specific lot ISO 13485:2016 - Medical Device Quality Management Systems 12
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
S Does IEC 62304 require documenting unresolved anomalies for all safety classes? IEC 62304 - Medical Device Software Life Cycle Processes 4
C Documenting Cleaning Production Lines in Medical Device Pkg facility ISO 13485:2016 - Medical Device Quality Management Systems 1
C Documenting Cleaning Production Lines in Medical Device Pkg facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Documenting Cleaning Production Lines in Medical Device Pkg facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Problems while documenting the SOUPs used for the software we are developing IEC 62304 - Medical Device Software Life Cycle Processes 4
R Documenting Self-Training and Effectiveness - ISO 13485:2016 Training - Internal, External, Online and Distance Learning 4
C Documenting Software Safety Classifications IEC 62304 - Medical Device Software Life Cycle Processes 4
B Approaches to Documenting an ISO 22000 FSMA Food Safety - ISO 22000, HACCP (21 CFR 120) 3
G Process for Product Safety - Ideas for Documenting Process for 4.4.1.2 IATF 16949 - Automotive Quality Systems Standard 3
dubrizo Are you documenting Internal Audit findings as NCRs? Internal Auditing 18
M What is the value of documenting in-process rework for easily-detectable issues? Quality Manager and Management Related Issues 4
R What is the typical industry standard for documenting Usability Risk? Human Factors and Ergonomics in Engineering 16
C Importance of Documenting NCP's and CA/PA's ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
D Documenting Meetings through Meeting Minutes or a Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Colin Objectives Form - Format for Documenting Information Security Objectives IEC 27001 - Information Security Management Systems (ISMS) 2
M Documenting Vendor (Supplier) Issues Document Control Systems, Procedures, Forms and Templates 4
V Documenting Exceptions and use of Deviation Request Form APQP and PPAP 2
K AS9100 Clause 7.2.2 - Documenting "Special Requirements" and risks AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
K Competence, Training and Awareness - Documenting Training and Confidentiality Aspects ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Documenting the Review of Adverse Effects from Rework ISO 13485:2016 - Medical Device Quality Management Systems 4
A Formal Way for Documenting Design Input Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Documenting 5S Guidelines in the Sales Department (Office 5S) Quality Tools, Improvement and Analysis 4
C Training Planning - Using Summary Sheet for Documenting Training Activities Training - Internal, External, Online and Distance Learning 3
J Requirements for Documenting Lifetime of a Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
A Best Practice for Documenting Design Reviews 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
F Documenting Historical Preventive Action at a Daycare Preventive Action and Continuous Improvement 20
N Documenting Medical Device Complaints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R Documenting Quality Inspections - Material Released prior to Lot Acceptance Quality Manager and Management Related Issues 10
V Documenting the Root Causes for Internal Audit Non-Conformance Findings Problem Solving, Root Cause Fault and Failure Analysis 5
V Approach towards defining/documenting Requirements COTS vs. New-Product Software Quality Assurance 1
Crusader New Documenting Methods for Manufacturing Process Audits? Process Audits and Layered Process Audits 9
M Documenting an outsourced process - Distribution company with some manufacturing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Process Map vs. User Guide - Documenting business procedures Process Maps, Process Mapping and Turtle Diagrams 3
T Documenting Effectiveness of Corrective/Preventive Action Nonconformance and Corrective Action 8
M Customer Format - Documenting Customer Software Requirement Specification and DDD Software Quality Assurance 10

Similar threads

Top Bottom