Auditing AS9100C Section 7.5.1.2

J

JoeOB

#1
Greetings.

I have a question about auditing for Section 7.5.1.2 ?the results of changes to production processes shall be assessed to confirm that the desired effect has been achieved without adverse effects to product conformity.?

The "without adverse effects" part is clear, but I was wondering if people audit for the "desired effect ... achieved" part. This would require a statement of the desired effect and then objective evidence that it was achieved.

Thanks for your thoughts.

JoeOB
 
Elsmar Forum Sponsor
J

JoeOB

#3
Sidney:

No, I had not seen that guide. Thank you for the reference. The guide does not advise looking for evidence that the desired effect was achieved, so the auditor's focus is only personnel authorization, a record of the change, and evidence of no adverse effects.

Thanks again.

Joe
 
M

Mike_H

#4
7.5.1.2 Control of Production Process Changes

a) Our workorder refers to "build per Engineering drawing" , but also specifies additional QA Inspections, handling steps and sometimes sections to capture results of tests. The Engineering drawing contains notes on the build process to assist production. To remove these notes would be a huge effort (not an option).

So my question is: is it possible to define "Production Process" as "Engineering drawing notes", even though we issue workorders which are designed to direct Production to built to the appropriate Engineering drawing, show part status at various points of manufacture and act as the quality record. Every time we issue the workorder, a copy of the drawing is attached so it is, in effect, an extension of the workorder.

It would certainly make life far easier. Drawing changes are controlled via our ECN process (including equipment, tooling and software which are all typically called up in the drawing). We raise NCRs to 'control and document' temporary departures away from drawing until the ECN is released, so I think this is ok here as well.
What's the general feeling?

(b) "...changes to production processes shall be assessed.." : the standard doesn't require records of this assessment to be maintained, nor does it require that the assessment is performed on the next production run or as soon as practical. What options are suitable without documenting the assessment on a separate form (which I'm balking at btw)? I'm thinking it would make sense to just keep the planned Final QA Inspection in place and verify (assess) it then.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
B AS9100C Auditing - The scare tactic AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S ISO 9001:2015 Internal Auditing Internal Auditing 8
H Auditing Santa's workshop General Auditing Discussions 0
C List of MDSAP Auditing Organizations Medical Device and FDA Regulations and Standards News 1
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
cscalise Suggestions for MDR Auditing tools EU Medical Device Regulations 1
J Auditing of Support Function IATF 16949 - Automotive Quality Systems Standard 9
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S Risk based internal auditing Internal Auditing 6
Randy Remote auditing (for disaster, disease, disturbance etc...) during the Neo Coronavirus Pandemic and Social Distancing Registrars and Notified Bodies 7
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
F AS9100D Internal auditing requirements Internal Auditing 11
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Best Practices for IT auditing - Is a session-id necessary for a complete audit trail? IEC 27001 - Information Security Management Systems (ISMS) 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
blackholequasar Internal Auditing Inspiration - Getting volunteers to perform internal audits. Internal Auditing 22
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
tony s What is the automotive process approach for auditing? IATF 16949 - Automotive Quality Systems Standard 2
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
R I've been auditing for a CB for 18 years General Auditing Discussions 10
P Consultant Auditing Qualifications Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
M We still have not received our certificate due to a 'backlog' with our auditing body Registrars and Notified Bodies 25
N Online Internal Auditing Course for ISO 13485 - Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 8
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
U Internal auditing - Company employees or contract second party Internal Auditing 10
J Recomended Values - Auditing process in a supplier IATF 16949 - Automotive Quality Systems Standard 18
M Canada - Registrars that allow e-auditing for ISO 9001? Registrars and Notified Bodies 4
K Internal Auditing - Umbrella QMS and Multiple Standards Oil and Gas Industry Standards and Regulations 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones? Canada Medical Device Regulations 7
Ed Panek Supplier Auditing - No purchases from our key suppliers in the last 24 months ISO 13485:2016 - Medical Device Quality Management Systems 5
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
qualprod Effective Auditing advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Acceptance of remote auditing techniques - Can you help me with my research? General Auditing Discussions 0
GStough Auditing Against Criteria Unfamiliar to Auditee - Yea or Nay? General Auditing Discussions 11
qualprod Auditing Product and Services doubts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Auditing support and management processes General Auditing Discussions 7
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
D MSDS / GHS Walk-through / Auditing Occupational Health & Safety Management Standards 6
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4
S ISO 9001 Audit Observations - Transitioning my career into auditing Career and Occupation Discussions 16
G AS9101 Rev F - Worksheets for internal auditing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
N API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers Oil and Gas Industry Standards and Regulations 5
M Auditing processes followed by employees placed on client's site Internal Auditing 4
S ISO 13485:2016 and MDSAP internal auditing ISO 13485:2016 - Medical Device Quality Management Systems 6
M Auditing a Contractor in EMS and Non Conformity Report General Auditing Discussions 1
Richard Regalado ISMS Auditing Guideline V2 (based from ISO/IEC 27001:2013) IEC 27001 - Information Security Management Systems (ISMS) 7

Similar threads

Top Bottom