Help needed on 2 TS 16949 Elements - 7.5.5 & 7.5.3

#1
7.5.5 Preservation of Product & 7.5.3 Identification and Traceability

Need help on 2 issues which I think I know the answer, however, we have had some push back on these.

7.5.5 - Finished goods storage where there is a 'A' Painted Surface finish, dust can collect over a period of 2 months. Auditors have told them they are OK.... I have never heard this... Would this be a finding as Dust is on the parts now...? However, you have to wipe the parts and your finger will have dust on it.

7.5.3 - Small bins where parts are stored are labeled correctly, however, they pulling the parts and laying in below the bins on the work table to use. Some auditors have told them as long as they are in the vicinity the parts would NOT be considered Unidentified.

Any help would be appreciated...!
 
Elsmar Forum Sponsor

Golfman25

Trusted Information Resource
#2
7.5.5 Preservation of Product & 7.5.3 Identification and Traceability

Need help on 2 issues which I think I know the answer, however, we have had some push back on these.

7.5.5 - Finished goods storage where there is a 'A' Painted Surface finish, dust can collect over a period of 2 months. Auditors have told them they are OK.... I have never heard this... Would this be a finding as Dust is on the parts now...? However, you have to wipe the parts and your finger will have dust on it.

7.5.3 - Small bins where parts are stored are labeled correctly, however, they pulling the parts and laying in below the bins on the work table to use. Some auditors have told them as long as they are in the vicinity the parts would NOT be considered Unidentified.

Any help would be appreciated...!
I see no issue with either situation. You have to be realistic.

a) Is there any harm from dust on the parts? Is the dust wiped off before use? In other words, what's the problem?

b) If you are using a part, how else would you identify it. The reality is that parts need to be removed from their container to be used. Close enough may in fact be close enough.
 
T

Taliesyn

#3
I agree - we use many small parts when assembling our products. These are put into small bins - with our internal part number on the bin - but a small pile of parts on the workbench to save reaching over the top of an assembly was deemed acceptable by our (ever so slightly picky!!) external auditor. As far as the dust on parts is concerned, if we have that issue, we clean them and check for scratches, etc. before assembly. Although, we don't have them hanging around for 2 months - ours are used pretty well same day half the time.
 
Thread starter Similar threads Forum Replies Date
E Help needed on the TS 16949 External Auditor Exam IATF 16949 - Automotive Quality Systems Standard 8
D Help needed for Compliance Road-Map - Startup making their first device (IVD) IEC 62304 - Medical Device Software Life Cycle Processes 1
V Root Cause help needed - Sheet metal breaking at press Problem Solving, Root Cause Fault and Failure Analysis 9
W TL9000 transition from 5.5 to 6.0 - help needed TL 9000 Telecommunications Standard and QuEST 1
kmyers Processing Time Tracking Software Program Help Needed Lean in Manufacturing and Service Industries 3
N VDA 1 Critical Characteristics Requirements Help needed VDA Standards - Germany's Automotive Standards 6
R Excel 2003 and Capability Studies for Dummies - Help needed! Excel .xls Spreadsheet Templates and Tools 4
R ISO 13485 Software Validation Requirements - Help needed ISO 13485:2016 - Medical Device Quality Management Systems 4
D Generating a detailed Process Plan - Help needed Process Audits and Layered Process Audits 6
R ISO 9001 Implementation in the Bus/Coach Industry - Confused and Help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
O ISO 9000 section 7.2.1(c) Compliance help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Regression Analysis for the Attached Data - help needed - TIA Reliability Analysis - Predictions, Testing and Standards 13
S Interpreting Level of Confidence - Round Robin for Tensile Testing - Help needed Statistical Analysis Tools, Techniques and SPC 4
J ISO 9001 and Improvement of Business Performance - Research help Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Dew Point Meter: DPL4000 - help needed Manufacturing and Related Processes 1
W Australian Approval for Class I Medical Device - Help needed. Other Medical Device Regulations World-Wide 1
R Student Question - Help needed with statistics questions Statistical Analysis Tools, Techniques and SPC 6
L Definition Throughput Yield (TPY) or First Pass Yield Calculation - Help Needed Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
P Sample Size Calculation help needed Reliability Analysis - Predictions, Testing and Standards 4
6 Preventive Action - Help Needed. Input for Training and Sustenance Preventive Action and Continuous Improvement 3
R ISO 13485 Surveillance Audit Nonconformances and Report Help Needed ISO 13485:2016 - Medical Device Quality Management Systems 9
V Help needed with ISO 14001 Procedures please ISO 14001:2015 Specific Discussions 7
A Help needed for Fighting a specifically identified Organism found during Dose Audit Miscellaneous Environmental Standards and EMS Related Discussions 2
D AASHTO R18 Accreditation (quite similar to ISO 17025) QMS - Help needed ISO 17025 related Discussions 4
L Gage Linearity and Bias Study Analysis - Minitab help needed Using Minitab Software 4
H Husky 1750PSI Pressure Washer - Help needed! Manufacturing and Related Processes 3
L Medical Device FDA Product Classification help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Cross Tabulation in Attribute MSA - Help Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Trend Review and Process Improvement help needed Capability, Accuracy and Stability - Processes, Machines, etc. 6
L Easy Access of Obsolete Documents - Corrective Action help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
T FDA Single Use Instruments - Classification Help Needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T PFMEA of Die casting Process--Help needed? FMEA and Control Plans 5
P Design FMEA (DFMEA) Basics - Help needed IATF 16949 - Automotive Quality Systems Standard 3
K ISO 13485 Audit help needed General Auditing Discussions 20
U Issue with Labelling of Outer Container - help needed for clarification EU Medical Device Regulations 3
B 5 Why help needed Please kindly review Problem Solving, Root Cause Fault and Failure Analysis 15
S Excel Spreadsheet Conditional Formatting help needed Excel .xls Spreadsheet Templates and Tools 12
G Help needed to complete a Financial Audit of a Nonprofit Organization Various Other Specifications, Standards, and related Requirements 7
K Low Volume Products Data Analysis help needed Statistical Analysis Tools, Techniques and SPC 6
somashekar Water and Air Pollution Load Calculations help needed Miscellaneous Environmental Standards and EMS Related Discussions 6
S Master Document Register Project Procedures help needed Document Control Systems, Procedures, Forms and Templates 2
Ajit Basrur Tabulating Improvement Plan Status - Help and suggestions needed Excel .xls Spreadsheet Templates and Tools 9
R Sample Audit Report of an Investment Company - Audit help needed Document Control Systems, Procedures, Forms and Templates 1
E FDA New Product Introduction Regulations help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R Process VSM (Value Stream Mapping) help needed Lean in Manufacturing and Service Industries 5
K Virtual DMIS vs. PC-DMIS - Help needed Calibration and Metrology Software and Hardware 3
T Excel Time Calculations and Formulas help needed Excel .xls Spreadsheet Templates and Tools 15
C TS 29001/API spec Q1- help needed Oil and Gas Industry Standards and Regulations 1
P HiPot Calibration help needed General Measurement Device and Calibration Topics 10
N Fluke 724 Calibration help needed General Measurement Device and Calibration Topics 8

Similar threads

Top Bottom