No evidence of certain processes on our scope being audited at our remote location

David J Quality

Involved In Discussions
#1
We recently incurred a minor NC on our last TS audit due to no evidence of certain processes on our scope being audited by our remote location's registrar. One of the processes is "strategic planning". No one here is sure how or why this came to be listed on our scope. Yes, our parent company in Japan does provide such instruction, but I am not sure this is an auditable process. Can anyone verify my assumption? I would prefer to remove this from our scope prior to our IATF audit this fall. Thanks!:thanks:
 
Last edited by a moderator:
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: No evidence of certain processes on our scope being audited at our remote locatio

As I understand the scenario described, my line of thought is:

  • "strategic planning" process does exist. Surely it is auditable.
  • strategic planning is a process that can affect product conformity and customer satisfaction, thus, it is a process that is part of the QMS.
  • strategic planning is in the scope of audit (and/or certification) of the remote location, by a different CB.
If all bullets are true, the solution is for strategic planning to be audited at the remote location and evidence be presented to the manufacturing plant(s) CB. You should NOT remove a QMS process from the scope of the audit at the remote location, if the process does exist and can impact your automotive customers.
 

Sebastian

Trusted Information Resource
#3
Re: No evidence of certain processes on our scope being audited at our remote locatio

I have various experiences regarding identification of remote supporting functions. Some companies take it very seriously and have very good understanding of interactions between manufacturing plants and design centres, sales offices, etc. Some do all they can just to limit scope of this functions to product, eventually process design activities. I am very familiar with tag, "Japan" in this matter. :D
What you need is to strongly insist on your Japanese friends to be open to their CB and do not hide these supports, as "overlooking" will result in major NC issued to you next time.
 

David J Quality

Involved In Discussions
#4
Re: No evidence of certain processes on our scope being audited at our remote locatio

I should have defined the problem better: our registrar came in and looked at our cert on the wall noting seven support functions from our RL. He asked to see the audit performed in Japan. When he looked at it he noticed that not all support processes were audited by their registrar. He didn't ask to see the three year audit plan (I'm hearing it wouldn't have mattered). According to the auditor, we must ask Japan to have their registrar come back to their facility and audit the missing support functions. Now, we do not list "strategic planning" as a process at our facility. I am not sure how it ever got on our cert. Is there a clause in IATF that specifically mentions strategic planning and that it should be a recognized auditable process? Thanks!:thanx:
 

Sebastian

Trusted Information Resource
#5
Re: No evidence of certain processes on our scope being audited at our remote locatio

1. Someone from your company mentioned this activity in application for certification.
2. Auditor found RL's support with this activity and mentioned it in final report.
 
Thread starter Similar threads Forum Replies Date
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
C MDCG 2020-06 Clinical evidence legacy devices EU Medical Device Regulations 3
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M Informational Critical Thinking and the Process of Evidence-Based Practice Medical Device and FDA Regulations and Standards News 0
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
S Level of Clinical Evidence - MDR EU Medical Device Regulations 3
qualprod Evidence of a talk or phone call in approvals? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Clinical evidence for Class II medical devices in EU and US EU Medical Device Regulations 5
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 7
N Best practices for capturing audit objective evidence in a practical manner? Internal Auditing 3
M Informational Health Canada – Guidance Document: Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing Medical Device and FDA Regulations and Standards News 0
R Timeframe for IATF 16949 certification to accumulate evidence of conformance of systems? IATF 16949 - Automotive Quality Systems Standard 2
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
E ISO 9001:2015 Clause 10.2.2 - Evidence of all nonconformities and actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R 8.1.3 Management of change - Evidence of HIRA and related things Occupational Health & Safety Management Standards 3
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
S Ways to demonstrate objective evidence that employee is trained and competent ISO 13485:2016 - Medical Device Quality Management Systems 28
mikinnear Evidence - Class IIb Disinfectant Sanitiser EU Medical Device Regulations 2
G FAI Objective Evidence AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Interested parties requirements - Evidence of control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Is evidence of second party audits required for every supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J MDR and Creative Clinical Evidence Other ISO and International Standards and European Regulations 2
B IATF 16949 Cl. 9.2.2.1 - Internal audit program - Types of evidence Internal Auditing 1
E IATF 16949 Cl. 7.1.5.1 - Documented information as evidence of fitness for purpose IATF 16949 - Automotive Quality Systems Standard 3
Q How to provide evidence of Strategic Direction (Easy) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B IATF 16949 Cl. 7.1.6 - Organizational Knowledge - What evidence to have? IATF 16949 - Automotive Quality Systems Standard 1
R CAPA Verification - ISO 13485:2016 Requirements and Objective Evidence ISO 13485:2016 - Medical Device Quality Management Systems 2
R What kind of Objective Evidence - AS9100 Cl. 7.1.6 - Organizational Knowledge AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Informational Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 82
O ISO 9001:2015 4.4.1 - Providing Evidence of QMS Processes "Shalls" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Type of evidence for Mandatory procedures 4.4.2 A ad 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Clinical Evidence - Clinical Evaluation Report for Class I medical devices EU Medical Device Regulations 1
L AIs the R&R study a training evidence considered ? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R What objective evidence can/can't be supplied during a customer audit? General Auditing Discussions 3
W Evidence for Review of Requirements - AS9100 Clause 7.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Audit Ethics and Practices regarding Evidence Internal Auditing 18
S Evidence of Competence, Training and Awareness Training - Internal, External, Online and Distance Learning 5
S Design and Development Document evidence for Engineering Consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Chennaiite Audit Objective Evidence - the holy **** Imported Legacy Blogs 1
J Evidence of ISO Training for all Employees Training - Internal, External, Online and Distance Learning 27
K Evidence for Language Knowledge of Employees Professional Certifications and Degrees 9
S What would be the evidence for trained/competent inspectors? Quality Manager and Management Related Issues 4
Q Closing Out a Corrective Action - Strictly what is an Evidence? Nonconformance and Corrective Action 8
T Safety and Effectiveness of Medical Device - What evidence needed? ISO 13485:2016 - Medical Device Quality Management Systems 4
T Clause 7.4.1.2 - Evidence of annual assessments for all non-TS Suppliers IATF 16949 - Automotive Quality Systems Standard 16
W Inspection Records Content and Acceptance Evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Evidence Documentation in Internal Audit Reports Internal Auditing 24
M Audit Interview as Evidence to issue a CAR (Corrective Action Request) General Auditing Discussions 13
G First Article Inspection Evidence AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4

Similar threads

Top Bottom