Manufacturing Process Audit Help

#1
Good morning Cove citizens,

I've been searching all morning on Elsmar and elsewhere and pulling my hair out over this. I apologize in advance if I'm hard to follow or misunderstanding key ideas, I'm new to IATF auditing and work for a small company with a lack of experience in the area. I'm trying to perform a manufacturing process audit according to clause 9.2.2.3 and am having trouble figuring out the best way to structure it. I've seen advice saying to follow the control plan and audit the steps outlined there (i.e. start with "process 2: secondary thread setup", audit that step, then move to the next one), and other advice stating it's necessary to audit the manufacturing process as a whole (i.e. starting with the first manufacturing step of screw machine setup and ending with secondary operations). I know the manufacturing process is okay, I just don't know how to prove it to an auditor. Thank you in advance for any help, and if anyone needs any more information or clarification please ask.
 
Elsmar Forum Sponsor

Johnny Quality

Involved In Discussions
#2
Leetster,

Just follow the process and acquire evidence that all is as it should be. You say the first step is "screw machine setup", how do you know what it should be and what evidence do you have that all is well?

Say a parameter has a range of X-Y as documented on file A in location B. Is B a sensible location? Is file A available and readable to the required personnel? Is it the correct revision level? Is the parameter within the range X-Y?

Document the pieces of evidence you used and what you see at the process.
 

bkirch

Involved In Discussions
#3
We walk the process using the control plan and work instructions as guides, and we maintain records of these audits. You may also look to see if any customer specific requirements apply. We have a few customers that require that we perform layered process audits which they state is a form of a manufacturing process audit. So we perform those as well.
 

Golfman25

Trusted Information Resource
#4
First we do our manufacturing process audits at the part number level -- meaning we pick a single part number and follow it thru the process, which can take a week or more. We created a checklist, based off our our control plans. Then they walk thru the process from receiving material to final inspection. They verify each step is done properly -- paperwork signed off, inspection results reported, etc. We audit several parts per year.
 

optomist1

A Sea of Statistics
Trusted Information Resource
#5
does your firm perform, or are LPAs (Layered Process Audits) required in your process, customer requirements?
 
#6
Thank you for your help everyone, I'll give it a go and report back.

does your firm perform, or are LPAs (Layered Process Audits) required in your process, customer requirements?
I don't believe we do LPAs right now, and we aren't required by any customers to do so at this time.
 
Thread starter Similar threads Forum Replies Date
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
Crimpshrine13 Is VDA 6.3 required for Manufacturing Process Audit (ISO/TS 16949)? Manufacturing and Related Processes 5
P Audit of the Manufacturing Process Effectiveness - 8.2.2.2 IATF 16949 - Automotive Quality Systems Standard 10
D At what stage should we proceed with manufacturing process audit? General Auditing Discussions 6
D How to Schedule a Manufacturing Process Audit General Auditing Discussions 13
Douglas E. Purdy Definitive Understanding of 8.2.2.3 Manufacturing Process Audit IATF 16949 - Automotive Quality Systems Standard 36
A Please Review my Manufacturing Process Audit Process Audits and Layered Process Audits 6
K Combined Environmental / Quality Manufacturing Process Audit Process Audits and Layered Process Audits 16
C Audit Checklists: Quality Management System - Manufacturing Process - Product IATF 16949 - Automotive Quality Systems Standard 6
R Roving Audits - Main functions is to audit the manufacturing process General Auditing Discussions 18
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 4
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 23
J Manufacturing Process Auditor Requirements - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 9
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
S Improving Quality inspection gate in one piece flow manufacturing process Manufacturing and Related Processes 0
H IATF 16949 9.2.2.3 - Manufacturing process audits IATF 16949 - Automotive Quality Systems Standard 9
M Requirement for manufacturing process validation in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 8
J Lean MFG (manufacturing) process and Work order templates Lean in Manufacturing and Service Industries 6
A Is a Manufacturing Process Sheet required for each Component? Manufacturing and Related Processes 4
V IATF 16949 Manufacturing Process & Product Audits IATF 16949 - Automotive Quality Systems Standard 1
M IATF 16949 Cl. 8.3 - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 1
M IATF 16949 - Cl. 8.3.3 - Product design inputs, manufacturing process design inputs IATF 16949 - Automotive Quality Systems Standard 4
L IATF 16949 Cl. 8.3.3.2 Manufacturing process design input - Process capability IATF 16949 - Automotive Quality Systems Standard 1
S Manufacturing Work Instruction examples that include process pictures Manufacturing and Related Processes 3
A IATF 16949 Cl. 8.3.5.2 e) - Manufacturing Process Flow Charts & Layout IATF 16949 - Automotive Quality Systems Standard 5
C Manufacturing Process Work Instructions - Format Manufacturing and Related Processes 4
B Process Risk Assessment Example for a Manufacturing Company Quality Tools, Improvement and Analysis 2
O PFMEA - Reducing Severity (S) Ranking - Manufacturing Process Design Changes FMEA and Control Plans 4
I Manufacturing build requests - process and form Other Medical Device Regulations World-Wide 4
L Most appropriate Auditor to check the FMEA & PCP of a Manufacturing Process IATF 16949 - Automotive Quality Systems Standard 5
M Manufacturing Process Validation Destructive Testing Sampling Plan Advice Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
A SOP for Marketing Process for a Medical Devices Manufacturing Company wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Process FMEA w/ Contracted Manufacturing ISO 14971 - Medical Device Risk Management 2
D Number of Manufacturing Lots for Process Validation Manufacturing and Related Processes 10
Q Medical Device Manufacturing Process Monitoring Best Practice ISO 13485:2016 - Medical Device Quality Management Systems 2
J What is Incorporation in Assembly/Manufacturing Process in FMEA? FMEA and Control Plans 4
T What tools are there to monitor a Manufacturing Process or Operation? Quality Tools, Improvement and Analysis 2
D Membrane Filter Materials - What process and Equipments used in Manufacturing? Manufacturing and Related Processes 1
C Severity of Effect on Process (Manufacturing/Assembly Effect) Scrap or Reworking FMEA and Control Plans 3
A ISO/TS 16949 - 7.3.3.2 Manufacturing Process Design Output IATF 16949 - Automotive Quality Systems Standard 6
Chennaiite Control Chart for Non-Manufacturing Process Indicators - Is it worth? Statistical Analysis Tools, Techniques and SPC 1
T Manufacturing Process Deviation linked to DMR (Discrepant Material Report)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Changes to Manufacturing Process or Device with CE Marking CE Marking (Conformité Européene) / CB Scheme 2
L Process Flow Chart for manufacturing of Light Switch requested Process Maps, Process Mapping and Turtle Diagrams 5
D How to measure Process Capability for Homogeneous Batch Manufacturing Capability, Accuracy and Stability - Processes, Machines, etc. 4
kedarg6500 Manufacturing Process Design and Development Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11

Similar threads

Top Bottom