Why 10 Working Days for a Corrective Action Response?

C
#1
10 days? Corrective action response.

I have a simple questions that nobody seems able to answer easily...

Why is 10 working days taken as the norm for a corrective action/8D response to a customer?
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
I think it's just a time period (2 weeks) that seems reasonable for most any company to at least provide an initial response.
 
S

Sporty

#3
My experience is that the OEM's want containment in 24 hours, and final resolution within 30 days.
 
D

D.Scott

#4
Our Customer Concerns must be answered (initial response) within 24 hours. Customer requirement of an 8D or not, they all get the same treatment.

Dave
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
It really depends upon the business with respect to what is an acceptable response time.

In the QS-9000 Semi-Conductor Supplement (as I remember) gave 24 hour containment which included tracking all shipped parts, etc. I think the first response had to be within 12 hours. It might have been 24-48. I forget now.

But my point is only to say it depends upon the business. Automotive will hold your feet to the fire, particularly if it's safety related or in some other way 'critical'. If you get a complaint from a customer via the 'Cracker Jack' people that one of the toy dolls you make for them to put into their boxes "...wasn't whole..." (mold didn't completely fill out or something) your response time will be different.

I can't speak for the medical device industry, but I betcha you don't get 10 days (which is generally accepted as 10 'working' days) in which to respond to a customer complaint.

That said, 2 weeks has been out there for a long time in many companies but I don't know where it 'started' or anything like that.
 
Thread starter Similar threads Forum Replies Date
B Any future for someone working as Lead Quality right these days? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
X Shall not exceed 2 working weeks = shall not exceed within 10 working days? IATF 16949 - Automotive Quality Systems Standard 2
Icy Mountain Audit Scheduling for TS16949 - Audit split up by several 'working days' General Auditing Discussions 7
John Broomfield Guidance on Safe Working During Covid-19 Pandemic Misc. Quality Assurance and Business Systems Related Topics 4
S Experience working with TUV SUD or Rheinland, and/or BSI Registrars and Notified Bodies 5
G Working on a Root Cause Problem Solving, Root Cause Fault and Failure Analysis 11
M Informational TGA-led IMDRF Personalised Medical Devices working group meets in Canberra Medical Device and FDA Regulations and Standards News 0
M Informational EU – Minutes of the 24 July 2019 SCHEER Working Group on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) meeting Medical Device and FDA Regulations and Standards News 0
Watchcat MDD, MDR/IVDR, Working Groups, Expert Panels, MEDDEVs and Other EU Guidances EU Medical Device Regulations 32
T Is anyone working with N299.1 (Supply/service to nuclear power plants)? Various Other Specifications, Standards, and related Requirements 0
M Informational EU – 12th Meeting of the Working Group on Guidelines on benefit – risk assessment of Phthalates in Medical Devices Medical Device and FDA Regulations and Standards News 0
G Anyone working with or planning to do business in the CBD (cannabidiol) industry? US Food and Drug Administration (FDA) 1
M Applicability of Means of Protection, working voltage in an Automated External Defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Sidney Vianna ISO 9001 News Tirelessly Improving the Brand Integrity of ISO 9001 - Working Group under ISO TC 176 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 42
E Feeling ill when working with adhesives Occupational Health & Safety Management Standards 2
M Informational EU – SCHEER – Minutes of the Working Group meeting on guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devic Medical Device and FDA Regulations and Standards News 1
T IEC60601-1: Isolation for an applied part with working voltage of 1500Vp. IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
Rameshwar25 Min working experience for IATF 16949 third party auditor IATF 16949 - Automotive Quality Systems Standard 5
J AS9100 - Working Outside of Scope of Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S ISO 13485 Cl. 6.2 Human Resources - Personnel working within the QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
K Outsourced Major Processes - Working for Two Sister Companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Working for multiple CB's (Certification Bodies) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
N Anyone working on NIST SP 800-171 (Network and Information Security)? Records and Data - Quality, Legal and Other Evidence 4
O Cleaning API Rotary Shoulder Connections Working Mates exposed to Outside Weather General Measurement Device and Calibration Topics 1
R Working on a 510(k) that is very similar to the predicate device Other US Medical Device Regulations 4
L How many working hours to required to implement ISO 14001 ? ISO 14001:2015 Specific Discussions 6
R How to Determine Working Voltage & Tolerance for Isolation Barriers? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S OHSAS 18001 - 4.3.2 Legal and Other Requirements - Working document or template Occupational Health & Safety Management Standards 2
D How Working Standard Calibration result use in Verification of Equipment General Measurement Device and Calibration Topics 7
W Control of Document - Working Instruction and Checklist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
W Working in a company where we try to implement ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 9
C "PEAK WORKING VOLTAGE" with a 220-240VAC nominal Power Supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
AnaMariaVR2 IMDRF Working With ICH on Harmonized Electronic Submission System for Drugs, Devices Other Medical Device Regulations World-Wide 0
J0anne US Working Permit Requirements for European Consultants Career and Occupation Discussions 2
E What are the major difficulties when working as a consultant in your industry? Consultants and Consulting 20
B Need help on an application we are working on Coffee Break and Water Cooler Discussions 4
A I am working in QA. How can I gain knowledge and skills on EHS system? Career and Occupation Discussions 4
K What are the challenges of working in UAE as an Auditor ? General Auditing Discussions 2
I IEC 60601-1 Least Favourable Working Conditions for Medical Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Working closer and better with Suppliers - Practical ideas to improve? Supplier Quality Assurance and other Supplier Issues 8
J Frequency of Re-Testing Working Standards (Secondary Reference Standard) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
R Supplier Satisfaction Survey about Working with us as a Customer Supplier Quality Assurance and other Supplier Issues 7
R Informational How to consider the Working Voltage for splitting 2MOPP IEC 60601 - Medical Electrical Equipment Safety Standards Series 39
M Working Styles - The lazy, last minutes type Career and Occupation Discussions 13
R Determining Working Voltage - Drawing a Medical Device Insulation Diagram IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Q Quality Working Documents in same QMS Folders? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Audit of Supplier who is working toward AS9100 certification General Auditing Discussions 5
R Metrology Control Charts for Reference and Working Standards General Measurement Device and Calibration Topics 6
M Working with the "USDA Process Verified" Program ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1

Similar threads

Top Bottom