SBS - The Best Value in QMS software

Manufacturing Process Subcontracted - How do I handle Cl. 7.5?

G

Gust_aboo

#1
Hello all

It's my firt post, and my first post in english, so i have to say 'sorry for my english'. I work on a engineering company who design and deliver product, but we subcontract the process of manufacturing. I don`t know how to face the situation, we can`t exclude 7.5 but we 'manufacture', how can I aproach the situation? Thank you so much.
 
Elsmar Forum Sponsor
#2
Hello all

It's my firt post, and my first post in english, so i have to say 'sorry for my english'. I work on a engineering company who design and deliver product, but we subcontract the process of manufacturing. I don`t know how to face the situation, we can`t exclude 7.5 but we 'manufacture', how can I aproach the situation? Thank you so much.
What ever is under clause 7 can be excluded.Just check the conditions for exclusion and you need to meet those conditions.

Also note that even though you outsource,you would be responsible for those products.Therefore appropriate controls need to be determined and implemented. (Refer clause 4.1 and notes of AS9100 Rev.C)
Extent of control needed for the process would be different if you do the final inspection yourself on 100% products and if you outsource the inspection activity also, to the manufacturer.Just an example.

Lighter side:why don't you ask the supplier also to be AS9100 certified for additional control?:tg:

Welcome to Elsmar Cove.
 
G

Gust_aboo

#3
Thank you for the answer, but I think I did`t explain very good. My boss want to include manufacturing in the scope of the certification, so excluding 7.5 is not my problem, is just the opposite, I need to include 7.5 but I don´t manufacture, and my supplier is not certified.
 
D

DrM2u

#4
To add to Joy's reply ... If you receive, store and ship the finished goods then:
- you still have to perform receiving inspection (clause 7.4)
- you still have to identify or at least define how the product is identified (7.5.3)
- you most likely need to ensure product traceabiltiy (7.5.3)
- you have to store and preserve the product while in storage (7.5.4)
- pull and ship the product (7.5.3, 7.5.4)

All these require controls as well (7.5.1). You might even do some validation (7.5.2) unless you outsource that to your suppleirs as part of product and/or process development.

Does this help with understanding how 7.5 could apply to your organization?
 
G

Gust_aboo

#5
Thank you DrM2u, all your information will be very helpfull. So for my understanding, I have to explain in my manufacturing process how I control the process of my supplier? And 7.6? We don`t have any measurement equipment, all the measurements are made by our supplier. Thanks again.
 
D

DrM2u

#6
Thank you DrM2u, all your information will be very helpfull. So for my understanding, I have to explain in my manufacturing process how I control the process of my supplier? And 7.6? We don`t have any measurement equipment, all the measurements are made by our supplier. Thanks again.
As far as the supplier controls goes, you have to look at the specific requirements of 4.1, like Joy indicated, and 7.4. You do not have to try to apply any of the requirements of 7.5 to the supplier, that is their job.

Regarding 7.6, just exclude it in your scope if you do not perform any inspection or testing using equipment that requires controls. Don't forget to justify the excusion (i.e. we don't have or use any equipment for inspection and/or testing).
 
#7
I have a small thought and it was generated in the room where many great thoughts took birth:).

You may agree that clauses like 8.2.3,8.2.4 have very strong relationship with manufacturing process.Even if you outsource those activities,you cannot exclude those clauses.Did you consider this aspect?
 
G

Gust_aboo

#8
No I did'nt, EXCELLENT POINT!!! You may have and excellent 'thinking room'! ;-P
All your apreciations will be very important to handle this point. So my subcontracted process of manufacturing will be controlled whith 8.2.3 and 8.2.4 clauses. Another question related to product control, wich is the difference between 8.2.4 and 7.4 clauses?
 
#9
Welcome to the Cove, Gust_aboo :bigwave:

I am entering the discussion a bit late, and by now it is obvious that your English is no problem, so that is one thing less to worry about. Besides, our members come from all around the world, and many of us (myself included) are not native English speakers.

/Claes
 
Thread starter Similar threads Forum Replies Date
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
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
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 6
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 25
J Manufacturing Process Auditor Requirements - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 11
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 11
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
Crimpshrine13 Is VDA 6.3 required for Manufacturing Process Audit (ISO/TS 16949)? Manufacturing and Related Processes 5
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
S TS 16949 7.3.3.2 Question - Manufacturing Process Design Output. IATF 16949 - Automotive Quality Systems Standard 8
R SOPs in Manufacturing - Has anyone got a management process that works? Document Control Systems, Procedures, Forms and Templates 4
J Production Process vs. Manufacturing Process - Differences IATF 16949 - Automotive Quality Systems Standard 2
N Causes of Disbond Defects in Composites Manufacturing Process Manufacturing and Related Processes 7

Similar threads

Top Bottom