Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Service

A

agodina

#1
Can someone explain what part 7.5.2 (Validation of Processes for Production and Service Provision) of the standard is asking for? Better yet, can someone give an example of a special process and how they would address the requirements stated in sub-parts a through e of 7.5.2 using the context of their example? Any assistance is appreciated. Thanks.
 
Elsmar Forum Sponsor
G

galcantar

#2
Re: Help Understanding Part 7.5.2 of Standard

we are manufacturing wiring harnesses for heavy construction equipment hiw it applied to us is the electrical test ( continuity) due to we can't check continuity on the wires assembly until at the end when we form and complete the harness assembly ... another example is we validate the forming board and the test program during 1st piece inspection when a final piece is made and after we check this piece meets all print/ specs requirements then we validate that the board - tets program was made correctly remember that ISO?TS manadtes to review the design, verify your process capability and validate that the part meet with all print/ specs requirements. I'll hope this can give you an idea..
 
A

agodina

#3
Re: Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Serv

So: When writing the Quality Manual is it appropriate to list specific 'special processes' unique to your organization (unable to check continuity, for example) and then summarize how the output of this exact process is validated? Or can you speak in generalities about how all 'special processes' are approached?
 
G

galcantar

#4
Re: Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Serv

it's up to you-- what we did is stablish these processes as a part of the Flow Chart, FMEA, Control Plan and we discribe them in detail using a specific work instructions
 
A

agodina

#5
Re: Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Serv

Got it. Thanks for your help.
 

Big Jim

Trusted Information Resource
#6
Re: Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Serv

So: When writing the Quality Manual is it appropriate to list specific 'special processes' unique to your organization (unable to check continuity, for example) and then summarize how the output of this exact process is validated? Or can you speak in generalities about how all 'special processes' are approached?
Yes, it would be appropriate. It is far from mandatory as there are only three things a quality must have (see 4.2.2), and this is not one of them.

For your consideration, some common "special processes" are welding, brazing, soldering, plating, and painting. Generally speaking, you can't tell the outcome of these processes from normal inspection.

Plating is an excellent example. Since normal inspection cannot tell you the outcome of plating, the plater follows a specification (recipe). He then monitors that process. He checks the chemistry in the tanks as often as needed to confirm they are correct and keep records of that. Ofter, the temperature of the baths is critical, so that is also monitored and recorded. The length of time in the tank and the electrical settings are also important so they are also recorded. In the end, the plating shop ships you the plated parts with a certificate saying they have followed the recipe and have records to prove they did.

I hope that helps.
 
Thread starter Similar threads Forum Replies Date
M Understanding AS9100 Clause 7.5.1.4 Post-Delivery Support Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
K Understanding Risk Management Requirements according to AS9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
O Need Assistance in understanding AS9100 Rev.B AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
J Properly understanding SPC - Newbie SPC questions Statistical Analysis Tools, Techniques and SPC 29
S Understanding control chart and measurement capability Statistical Analysis Tools, Techniques and SPC 2
P Minitab Data Analysis - Understanding if a Process is in Control or Not Using Minitab Software 2
R Understanding a few points on ISO 9001's Design and Development Planning ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Understanding Cycle Time - Why the time of the other activities are left out Lean in Manufacturing and Service Industries 11
J Understanding ISO 9001:2015 - 10.3 Continual Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
E Understanding of TS 16949 Clause 7.6.2 IATF 16949 - Automotive Quality Systems Standard 5
K Understanding IEC 60601-2-68 requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Understanding the absolute uncertainty specification for a Fluke 5500A Measurement Uncertainty (MU) 3
N Understanding, Challenging & Approving Supplier Control Plans FMEA and Control Plans 7
M Definition Recommendations - Understanding "recommendations" and "recommended corrective action" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
T Understanding USP <1112> Water Activity as applicable to Medical Devices Other Medical Device and Orthopedic Related Topics 4
S MIL-HDBK-217 - Understanding the various Environmental Conditions Reliability Analysis - Predictions, Testing and Standards 1
D What is your understanding or interpretation of TS16949 7.4.1.2 IATF 16949 - Automotive Quality Systems Standard 6
C Understanding the relationship between 62304 and the MDD ER IEC 62304 - Medical Device Software Life Cycle Processes 7
S Understanding Subgroup Size - Multi Cavity (Minitab) Statistical Analysis Tools, Techniques and SPC 4
R Understanding clause 15.4.2.1 d) of amendment 1:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Understanding accreditation, MoUs, certifications Other ISO and International Standards and European Regulations 28
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
M Understanding Versions of Collateral and Particular Standards IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S Understanding, Analysis and Monitoring Quality Defects on Composite Components Statistical Analysis Tools, Techniques and SPC 3
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
B Understanding why my CpK and PpK are low, and LCL Statistical Analysis Tools, Techniques and SPC 20
S Understanding Quality Objectives, Metrics and KPI ISO 13485:2016 - Medical Device Quality Management Systems 15
Q Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards Philosophy, Gurus, Innovation and Evolution 12
Q Understanding Configuration Management AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
W Understanding PPAP Appearance Approval APQP and PPAP 22
V Understanding Automotive Coating for Seating Mechanism Components Manufacturing and Related Processes 1
M Understanding of Regression and ANOVA in Minitab Statistical Analysis Tools, Techniques and SPC 8
4 Understanding ILAC policy P14:12/2010 6.3 part a) General Measurement Device and Calibration Topics 28
H Understanding 8.2.3 M&M of Processes for our Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Understanding ISO 26262 Road Vehicle Functional Safety Other ISO and International Standards and European Regulations 2
arios Understanding adoption of a product to an existing Sterilization Cycle Other US Medical Device Regulations 1
M Learning ISO 13485 - Getting a better understanding of the requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
S Understanding FDA rules regarding MDDS Status and Clinical Trials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Understanding Identification of Design in QSR 21 CRF Part 820.30 Design Control (f) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Similar threads


















































Top Bottom