SBS - The best value in QMS software

Rules for Achieving IATF Recognition: 4th edition for ISO/TS 16949

J

jelly1921

Quite Involved in Discussions
#81
#81
Another question is still related to audit hours of manufacturing process

FAQ # 10 issued in May 2014

The rounding of audit days always occurs at the end of the audit day calculation result – see example below.
Example:
Client?s key data:
- single site with 225 employees
- non-design responsible
- 9 monthly surveillance audit interval

The next audit is the 2nd surveillance audit. A translator is needed for auditing in the manufacturing / production area only, which is estimated as 1.5 total hours (or 1.5 hours / 8 hours =.19 days) at the next audit.
From the initial audit day Table 5.2, minimum audit days for 225 employees is equal to 8.0.
The correct calculation (for a 9-monthly surveillance interval) is: 8.0 audit days – 15% discount = 6.8 days / 3 surveillance audits = 2.27
2.27 (min. audit days) + .19 (for translation) = 2.46 rounded up to 2.5 days for the 2nd surveillance audit.

If we ignore the translator issue, is it allowed to allocate 1.5 hours to manufacturing / production area in the case of total min. audit day is 2.5md?

As I understand, it shall be 2.5/3 = 0.8333 md = 6.67 hours

Thanks

Jelly
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
J

jelly1921

Quite Involved in Discussions
#82
#82
How to understand the word of "consecutive" ?
In 5.7, it says: In creating the process-based audit plan, consideration shall be given to timing of activities over consecutive days to give a sequence that avoids unnecessary duplication of visites to one process.

But in FAQ 12 issued in May 2014, it is allowed for CB assign 2 audit team members for a 15 day audit. That means there is a weekend between 15 days audit.

In that case, how to apply the requirements in 5.7 mentioned above?

Jelly
 
Last edited:
xfngrs

xfngrs

Quite Involved in Discussions
#83
#83
Okay. - here's a new question. We are considering moving some of our processes to a site down the road. They are Receiving, Tollgate and shipping. Are those 3 processes considered Manufacturing? Or would that be a remote site?

Per the new Rules - Manufacturing ? The process of making or fabricating production materials, production of services parts, assemblies, or heat treating, welding, painting, plating or other finishing services of automotive-related parts.

Remote location ? location that supports site and at which non-production processes occur.

Thanks,
 
S

soulmas

Involved In Discussions
#84
#84
xfngrs... I just noticed that nobody replied you back.... OK, the answer is that it will be considered as a manufacturing location... so, you will have to consider that location like a stand alone manufacturing plant.. even that it is just crossing the street, being in a different address, it will be considered as independent from your main mfg location.

With the new rules... my auditor days increased a lot....

however you can reduce the number of auditor days having a mini-corporate scheme.. with your new mfg location and your main location, you can apply the 20% discount.
 
T

T. Todorova

Registered
#85
#85
Hello! :bigwave:
Our company is almost out of space, so we need to move our assembly process to the building next to ours.
We are going to move just the assembly machines, the workers and the QA we have current.
They stay under the old umbrella - same management, QA manager, internal audits, management review, HR, shipping, maintenance - they all stay in the current location and the shipping will be from the current address.
Is this considered a new site and what we need to do to be in compliance with the 4rth Edition requirements?
There is no such a case in the FAQ. :rolleyes:
This is expansion, not a move (complete or partial).
Thank you!
 
S

soulmas

Involved In Discussions
#88
#88
T. Todorova... an expansion in a different address will be considered as another location so, a new certificate will be required...more auditor days will apply, you will have an additional report and even a separate opening and closing meeting, only for that particular location. Just like psocks101 says... separate building equals separate certs..
 
T

T. Todorova

Registered
#89
#89
Thank you all for the replay!
I'm sorry to hear this :(, but I was expecting it! They are punishing us for the expansion!
So we need to go with the Corporate Scheme :mg:. Are they going to issue separate Certificates with different addresses?
We will be shipping from the old address, do we need to PPAP with the new address?
Who is your CB by the way? Might be the same as ours :cool:
 
S

soulmas

Involved In Discussions
#90
#90
For the main location and your expansion, you can have a mini corporate scheme with 20% discount of auditor days... yes, you will have different certificates. Regarding PPAP, check section 3 of the PPAP AIAG manual... moving a line from one location to another (even in the same building), you should get customer approval and PPAP submission is required unless you get a customer waiver. Our registrar is DQS.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Crimpshrine13 Rules of achieving and maintaining IATF recognition - Determining audit days IATF 16949 - Automotive Quality Systems Standard 2
J Rules for Achieving IATF Recognition 3rd Edition FAQ?s - Certification Decision 5.12 IATF 16949 - Automotive Quality Systems Standard 2
M Rules for achieving IATF (International Automotive Task Force) recognition IATF 16949 - Automotive Quality Systems Standard 1
J Certification Scheme for ISO/TS 16949:2002 - Rules for achieving IATF Recognition IATF 16949 - Automotive Quality Systems Standard 4
P IATF Information - Rules for Achieving IATF Recognition - TS 16949 3rd Edition ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 23
C Help with Rules for achieving IATF recognition IATF 16949 - Automotive Quality Systems Standard 7
A Rules for Achieving IATF Recognition - A Second Edition for ISO/TS 16949:2002 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 10
S IATF Certification Rules - "Rules for Achieving IATF Recognition" 2nd edition soon? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 14
M Rules for achieving for ISO/TS 16949:2002 Certification (Registration) IATF 16949 - Automotive Quality Systems Standard 7
O Release of Sanctioned Interpretations (SIs) related to Rules 5th Edition and Sanctioned Interpretations related to IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 0
G IATF Rules for COVID 5th revision - Re-certification audit timing IATF 16949 - Automotive Quality Systems Standard 3
T IATF Rules for sharing production space with another company IATF 16949 - Automotive Quality Systems Standard 10
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 12
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Drugs and Cosmetics Rules - India Other Medical Device Regulations World-Wide 0
G Do HIPAA Rules Apply to a 3rd Party Logistics Shipper? Other US Medical Device Regulations 2
shimonv Rigid rules for handling supplier audit findings ISO 13485:2016 - Medical Device Quality Management Systems 11
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
M Informational TGA – Advertising health products: Rules about safety claims in advertising Medical Device and FDA Regulations and Standards News 0
D Volkswagen Complaints Management Rules Customer and Company Specific Requirements 0
M Informational US FSA – Surgical staples – Guidance and proposed rules Medical Device and FDA Regulations and Standards News 0
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Medical Device and FDA Regulations and Standards News 0
M Why have IATF rules required the CBs to audit remote supporting functions at first? IATF 16949 - Automotive Quality Systems Standard 11
T Informational Family or Baseline PFMEA Rules FMEA and Control Plans 22
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
M Medical Device News FDA Withdrawals Two Proposed Rules Other US Medical Device Regulations 0
R How to keep track of all FDA rules and regulations for medical device companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C What are rules to notify customers if IATF cert is put on hold? IATF 16949 - Automotive Quality Systems Standard 2
L What are the rules on significance of digits in numbers in IEC/ISO standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Rules associated with introducing new QMS processes IATF 16949 - Automotive Quality Systems Standard 1
R IATF 16949 certification rules IATF 16949 - Automotive Quality Systems Standard 5
K Rules or guidelines for quoting FDA announcements and such? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M INDIA - GSR 78 (E) - New Medical Device Rules - 2017 Other Medical Device Regulations World-Wide 6
L Hypothesis Testing + Thumb Rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
L Percentage Thumb Rules for Quality Costs Misc. Quality Assurance and Business Systems Related Topics 1
A EASA Easy Access Rules for Continuing Airworthiness - June 2017 EASA and JAA Aviation Standards and Requirements 0
Sidney Vianna IATF 16949 Areas of Impact - Rules 5th Edition Document (February 2017) IATF 16949 - Automotive Quality Systems Standard 0
Uriel Alejandro Including "Internal Rules" as Controlled Documents in a QMS Document Control Systems, Procedures, Forms and Templates 7
Marc Rules for Posting in the Paid Consulting, Training and Services Forum Paid Consulting, Training and Services 3
M I am looking for the text of the copyright 'rules' for AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Anerol C IATF or ISO TS 16949 rules about Scope of QMS IATF 16949 - Automotive Quality Systems Standard 7
Ajit Basrur New Medical Device and IVD Registration Rules - Pakistan Other Medical Device Regulations World-Wide 5
A PUWER (Provision and Use of Work Equipment Regulations) and old machines (UK rules) Occupational Health & Safety Management Standards 4
M Translating and Rotating Rules when programming or measuring with a CMM Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Are there specific rules regarding ISO 13485 and R&D? ISO 13485:2016 - Medical Device Quality Management Systems 4
Mikey324 Questionable Audit Findings after Rules 4th Edition Release IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom