Timely Review of Engineering Specifications - 4.2.3.1 - Two Weeks?

H

Hermann - 2011

#1
#1
Has anybody else noticed that 16949 § 4.2.3.1 requires review of changes within 2 weeks.
This is new in as much as we normally define how quickly we review specs. It can take longer (depends on complexity).
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
Dave.C

Dave.C

Involved In Discussions
#2
#2
I think the intent of this clause is to ensure the organisation at least does a quick feasibility review when receiving new specs, so that major changes, potential delays or problems are flagged up in a timely manner, or am I on the wrong track here?:rolleyes:

Dave.C
 
B

BobD

#3
#3
Dave C...

I agree with you that it means a quick review and not actual implementation. The key phrase in 4.2.3.1 is "based on customer required schedule".

In our case, we are a ductile iron foundry supplying parts to the B3. The receipt of an engineering change may mean extensive tooling modifications or maybe all new tooling. This alone can take 3-6 weeks. Then we have to proto-type and sample the customer for their approval. Depending upon how fast the customer moves on it, final approval can take 6-weeks to 6-months.
 
R

rsalinger - 2007

#4
#4
I think the two weeks time frame is very similar to what QS-9000 said on this subject...reviews should be done in days, not weeks or months(4.5.2.1). They just got more specific.
 
Q

qsmso

#5
#5
What should two weeks mean?

Dear friends,
My question doen't mean anything except I really want to know what is the general interprettion of "TWO WEEKS"

Last QS audit, my auditor issued deviation to us for stating to review within 10 business days. The auditor said that timely review must be one week or five working days.

Any comment?

QSMSO
 
Dave.C

Dave.C

Involved In Discussions
#6
#6
qsmso,

I would disagree with your auditor, in that if you think 10 business days is timely for your business to conduct a review, who is he to dictate to you how you should run your business!!!! :eek:

Seems to me that TS may be trying to clear up the argument over what is a timely review.

Dave.C :bigwave:
 
S

Sam

#7
#7
The inteny,IMO, is to review the changes to determine a course of actionn, not to have a completed changerd product/process within the two weeks.
IMO, customer requests for changes should br "reviewed" for impact the minute they are received.
First, for the effective date of the change; you may need to stop production,
second, the nature of the change; a quick review will enable you to provide a timeline for initiating the change.
 
D

db

#8
#8
Days

Last QS audit, my auditor issued deviation to us for stating to review within 10 business days. The auditor said that timely review must be one week or five working days.
Click to expand...
I think the auditor is referencing 4.5.2.1 "e.g. business "days", not weeks..."

In a strict interpretation, we could conclude anything over one business week would then be falling into the category of "weeks", not "days".

TS gives a little more leeway in that it gives two weeks. However, I could see a case for arguing that the two weeks also include the distribution and implementation. I do think that this is a stretch and agree with the other posts in that the requirement is for the review only.
 
D

Don Wood - 2011

#9
#9
Two Weeks

The requirement applies ONLY to the review, not implementation.

Two weeks means two working weeks from reciept of the documents/data from the customer. Ten business days is not an unreasonable way to define this.

Don Wood
Deosil Management
Licensed Plexus Service Provider/Registrar Auditor Master Trainer
(I'm one of the folks that certifies the CB auditors)
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S TS 16949 Requirements for Timely Review of Engineering Specifications IATF 16949 - Automotive Quality Systems Standard 6
T TS 16949 - 4.2.3.1 Engineering Specifications - Process to assure timely review, etc. IATF 16949 - Automotive Quality Systems Standard 1
S TS 16949 Clause 4.2.3.1 - Process to assure timely review - Two weeks IATF 16949 - Automotive Quality Systems Standard 2
D Customer Specifications - Timely review (e.g. business ?days?, not weeks or months) Document Control Systems, Procedures, Forms and Templates 14
K FAA Audit - Major nonconformity for lack of timely calibration of two devices EASA and JAA Aviation Standards and Requirements 5
T Timely Closure and "Ongoing" Corrective Action Nonconformance and Corrective Action 15
J Specific Actions where Timely and/or Effective Actions are not Achieved Nonconformance and Corrective Action 6
M Definition Timely - Definition of "timely" in AS9100 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
M Benchmarking - Timely Closure of Corrective Actions Nonconformance and Corrective Action 3
Mikishots How to handle CAR (Corrective Action Request) Scope vs. Timely Response Nonconformance and Corrective Action 9
E C/A (Corrective Action) not closed in a timely manner Nonconformance and Corrective Action 26
P Convincing Suppliers to Send 8D Reports and React to Complaints in a Timely Manner Supplier Quality Assurance and other Supplier Issues 24
R AS9100 Revision A - Timely and effective corrective actions not achieved AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Timely Response for Preventive Actions - How can we assure a timely response? Nonconformance and Corrective Action 5
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Forms review Manufacturing and Related Processes 5
V Quality review Meeting with Customer for complaints we received Customer Complaints 6
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
D CSV - Periodic Review Qualification and Validation (including 21 CFR Part 11) 1
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
T Management review meeting workflow ISO 13485:2016 - Medical Device Quality Management Systems 9
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
B Label Review for Class II Device US Food and Drug Administration (FDA) 0
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Casana ISO 9001 - 9.3.1 Management Review - Attendees in a flat organization Management Review Meetings and related Processes 6
C Management Review Agenda Management Review Meetings and related Processes 20
A Literature review/HACCP validation of metal detection Food Safety - ISO 22000, HACCP (21 CFR 120) 0
Q Do Management Review records have to be on a controlled form? ISO 13485:2016 - Medical Device Quality Management Systems 30
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
W ISO 9001:2015 Management Review Input Template wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
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
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests Medical Device and FDA Regulations and Standards News 1
C Design Transfer Review - Before or after PQ validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3
G ISO 9001 - 9.3.1 Management Review - Content and Frequency Management Review Meetings and related Processes 12
Nicole Desouza Contract / Customer Order Review Checklist Needed Manufacturing and Related Processes 12
M Informational Updated US FDA Resources for Third Party Review Organizations Medical Device and FDA Regulations and Standards News 0
D Document review on already approved registrations requested by China's NMPA? China Medical Device Regulations 3
J Literature Review (marketing etc) ISO 13485:2016 - Medical Device Quality Management Systems 1
M Informational US FDA – Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health – Final Rule Medical Device and FDA Regulations and Standards News 0
S ISO 9001:2015 Clause 9.3.2 - MR (Management Review) - Adequacy of resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q How to run a Management Review Management Review Meetings and related Processes 10

Similar threads

Top Bottom