Should Customer Complaints trigger Internal Audits?

Elsmar Forum Sponsor
R

RosieA

#2
Andrews, I wouldn't schedule an internal audit unless I felt that there were unknown process problems behind the complaint. An audit is generally not the right mechanism for complaint resolution in my company.
 
D

D.Scott

#4
I agree, follow the 8-D format (or whichever one you like). It may lead to an internal audit but that wouldn't be where you start.

Dave
 
R

Rockanna

#5
Customer Returns

We perform investigation of the root cause for the item being returned. If the investigation points to our current process causing the failure, we document a corrective action plan and within an acceptable amount of time schedule a follow-up to verify the effectiviness of the C/A plan.

We may only have 5 items returned per year due to our extensive testing before the product leaves the building.

My question is what would be the benefit of scheduling an internal audit?

We leave the investigation up to the folks who control the process - Manufacturing Engineers and/or Quality Engineers.

Our internal auditors are from numerous departments throughout our facility, total of 28. Due to our manufacturing process, it would be difficult for them to determine any root cause of the product failing.
 
A

Andrews

#6
Wouldn't an internal audit (independent person) help find the root cause of the problem because usually personnel on the shop floor may attribute some cause (not the root cause) because they may be biased during analysis ? Am I wrong ?
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
Andrews,

Perhaps due to language differences we're confusing an internal audit with a root cause investigation. I generally think of an internal audit as something done 1-3 times a year company-wide to determine if the procedures and processes are ISO compliant and to verify that the procedures are being followed as they are supposed to be, etc.. It is probably not practical or advisable in most companies to do a full audit every time a customer complaint comes in. Most companies prefer to do an investigation specifically targeted at determining the cause of the specific defect/complaint. This is probably a more focused effort that does not waste time and resources looking at areas unrelated to the problem. Also, some larger companies or companies with higher defect/complaint rates may get 10, 20, 30 or more such complaints a year and it would be impractical and a waste of time/resources to do an internal audit for each one. Often the cause of a defect can be determined very quickly without lots of time/effort but sometimes the cause must be investigated on a much deeper level than a typical audit. You can still have have an independent person investigate or review the results of the investigation. JMO.
 
Thread starter Similar threads Forum Replies Date
D Responsibility of Distributor for Customer Complaints - How should we handle this Customer Complaints 5
J How should customer complaints be handled to comply with ISO 9001? Customer Complaints 4
D What should ?Customer Complaints? include? Customer Complaints 15
R Customer Complaints Processing - How long should it take??? Customer Complaints 15
Q How should I analyze measurement correlation between me and customer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
G ISO 17025:2017 7.1.2 - Should I produce a document for the customer? ISO 17025 related Discussions 8
MrPhish Should Potential Customer Complaint Outcome Define Registrar NC Rating? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T EASA P 145: What mandatory information should on the purchase order of the customer ? EASA and JAA Aviation Standards and Requirements 2
G Should the Quality Department originate a Request for Deviation to the Customer? Nonconformance and Corrective Action 3
B Should I Request/Submit a PPAP from/to a Supplier/Customer for only Repackaging Parts APQP and PPAP 7
D Should Customer Drawings be controlled per AS9100 QMS ? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Should I file a Customer Complaint as a Nonconforming Material Report or a CAP? Nonconformance and Corrective Action 5
K Should prices be included in customer related process ISO 13485:2016 - Medical Device Quality Management Systems 1
J Who should accept the samples of Customer Complaint products ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Who should be the person to release product to customer ISO 13485:2016 - Medical Device Quality Management Systems 34
A Cost calculation for solution that should delight the customer Quality Manager and Management Related Issues 3
S Should we make acceptance specification looser than customer?s specification? Quality Manager and Management Related Issues 14
M Customer is also my supplier - Should I perform an audit to his process? IATF 16949 - Automotive Quality Systems Standard 6
A Should I use "Client" or "Customer" in my documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
tony wardle Customer Visit Reports - What should a Customer Visit Report look like? IATF 16949 - Automotive Quality Systems Standard 11
P QMS-requirements should be excluded from the customer specific requirements Customer and Company Specific Requirements 13
K Customer survey question service - What a company should be willing to pay IATF 16949 - Automotive Quality Systems Standard 3
M Customer Satisfaction: We're Doing Surveys - What Else Should We Do? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Rework and PPAP - When should we notify the customer? QS-9000 - American Automotive Manufacturers Standard 2
N How should I interpret Voice of the Customer QS-9000 - American Automotive Manufacturers Standard 1
Marc Customer advocacy should be contained in the company business plan QS-9000 - American Automotive Manufacturers Standard 1
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 2
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 21
D Class II medical device - When should a complaint be closed? Customer Complaints 6

Similar threads

Top Bottom