Quality Assurance in China - Developing a quality management system for a California company

#1
Hello,

I am new to the forum so if this is already discussed somewhere else please point me in the right direction.

My situation is that I was recently hired (I'm 2 months in) to develop a quality management system for a California based hand tool company. The vast majority of the products are manufactured in China. We currently employ 2 people who work in China (full time) to visit each vendor regularly to perform product acceptance inspections. Having the 2 people in China has gone a long way to improve the product quality or so I've been told. They currently spend a lot of time traveling to and from each vendor with calibrated measurement equipment and aren't able to perform a very thorough inspection on every product prior to kitting the final product. The inspection plans and subsequent quality related processes are still being developed but will require more in depth product inspection than what is currently being performed. Currently only about 50-75% of the items are being inspected and most of those items are only being visually inspected.

My question is how do companies typically handle quality inspections in a foreign country?

My initial thought was to setup an inspection/warehouse office in China that they can work from instead of traveling to and from each vendor for inspections. This seems like the most logical step to me but I am not familiar with what it would take to setup an office in China so I was hoping to hear what other companies do in similar situations.
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Welcome to The Cove.

My question is how do companies typically handle quality inspections in a foreign country?
It depends a lot on who the customer and the suppliers are. It depends on the type of product and the volume, as well. The ideal scenario would be one where your organization did a good due diligence of selecting reliable suppliers, and the owners/bosses did not let low pricing be the only factor in the supplier selection process. There are a number of cases where faulty consumer goods were imported from shady suppliers, leading to injuries and fatalities, what, in places like the USA, translate into multi-million dollar lawsuits. In other words, being cheap ends up being very costly.

From what I gathered, over the years, the supply chain in China can be problematic. Numerous stories of bait and switch situations, inconsistent quality, unresponsive suppliers, etc... So, assuming you are "married" (i.e., a divorce is costly) to the current suppliers, one thing you can and should do is to document any quality issues that are critical in nature and/or repetitive and, demand robust corrective actions so such problems are "resolved".

Your strategy of performing source inspection at the suppliers is advisable, but, at the same time, make sure the supplier(s) understand that your inspections are NOT SUPPOSED to replace their QA/QC checks. In the developing world, there is a lot of misunderstandings about source inspections and I have found out that some companies stop doing all inspections because they think they no longer have to check the hardware, since the customers are performing inspections. And I have even heard some horror stories that the source inspectors being bribed to report huge lots of products as being good, when the suppliers know they were defective.

Finally, if the suppliers have ISO 9001 certificates and fail to adequately respond to your corrective action requests, you should engage with their certification bodies, as they have some leverage over the supplier that you don't.

Good luck.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
How would you do it if your vendor was in New York?
Very differently, since in New York, he would not have to deal with the language, cultural, and geo-political barriers he has to deal with doing business with suppliers in China. Chances are, he would not have to have source inspectors going around their suppliers. On the other hand, he would probably be paying 3-4 times the prices he pays from China.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
This thread is a little outside my comfort zone (medical devices), but still, some general comments -

It sounds as if the OP is operating in the low-cost/commodity zone (hand tool kits). This is commercially a very competitive zone - I always marvel at the amazingly low prices of such products (typically made in China) in mainstream Australian outlets - how can they turn a profit at all?... So I assume that the quality/efficiency room to manoeuvre is extremely limited from the get go. Difficult situation.

The second thing I noticed is that the OP (and some of the discussion that followed) focused on QC. QC is not QA, or in other words, QC is not the only way to achieve improved Quality. In the bigger picture, it's arguably not even the most efficient way. Normally I would zoom-out and ask myself how can Quality be guaranteed/improved in that situation WITHOUT so much QC (=inspections). But given the nature of that industry, compounded by language and cultural barriers, I'm not sure that this would be a good move. Definitely if the supplier was NY-based I would have advised considering the larger toolbox of QA rather than just trying to streamline QC.

Without top management buy-in and active support it's going to be difficult to achieve much either way. I think it's quite inevitable to see some initial decline in profitability if Quality is to be improved, and processes streamlined and made more efficient, in the longer run. It will take a bit more foresight on top management's part than the next quarterly report to get there.
 
#6
Since shipping times are not nearly as long, we probably would just have parts shipped to our facility for inspection and wouldn't have 2 employees doing it there. Potentially cutting up to 100 days out of the corrective loop is driving the desire to catch defects in China vs the USA.

Just to reiterate, my question is regarding how to manage inspections in China due to the long travel times between vendors with calibrated equipment, the Chinese governments regulations, and the reasons that Sidney Vianna and Ronen E. mentioned. The two employee's that we have in China are instrumental in working directly with the vendors to overcoming those barriers as we develop the QA program and I don't want to get rid of them just on a whim.

Starting with the QC inspections is allowing me to see where the holes like data capturing, design standards, vendor qualification, risk analysis, vendor contracts, etc. are in the rest of the processes. As the QA program is developed I plan to expand the standard processes such that we transition from reactionary quality control practices to preventative quality assurance practices. I doubt we will ever get to the point where we do APQP but we have to start somewhere and build our way up through continuous improvement.

A vendor that has been used for a couple years now that I just met a week ago said that their sewing process is manual so they can't improve the quality and defects will happen. Other vendors made similar statements expressing a "good enough" mentality. Like many small growing businesses nobody had time to address this with the vendors so they have been getting away with it a lot. This obviously is not acceptable (which I expressed to the vendor already) but I don't have the luxury of starting completely over with the supply chain to find quality suppliers.
 

greenlantern

Starting to get Involved
#7
Since shipping times are not nearly as long, we probably would just have parts shipped to our facility for inspection and wouldn't have 2 employees doing it there. Potentially cutting up to 100 days out of the corrective loop is driving the desire to catch defects in China vs the USA.

Just to reiterate, my question is regarding how to manage inspections in China due to the long travel times between vendors with calibrated equipment, the Chinese governments regulations, and the reasons that Sidney Vianna and Ronen E. mentioned. The two employee's that we have in China are instrumental in working directly with the vendors to overcoming those barriers as we develop the QA program and I don't want to get rid of them just on a whim.

Starting with the QC inspections is allowing me to see where the holes like data capturing, design standards, vendor qualification, risk analysis, vendor contracts, etc. are in the rest of the processes. As the QA program is developed I plan to expand the standard processes such that we transition from reactionary quality control practices to preventative quality assurance practices. I doubt we will ever get to the point where we do APQP but we have to start somewhere and build our way up through continuous improvement.

A vendor that has been used for a couple years now that I just met a week ago said that their sewing process is manual so they can't improve the quality and defects will happen. Other vendors made similar statements expressing a "good enough" mentality. Like many small growing businesses nobody had time to address this with the vendors so they have been getting away with it a lot. This obviously is not acceptable (which I expressed to the vendor already) but I don't have the luxury of starting completely over with the supply chain to find quality suppliers.
Very late response, but I'm in a similar situation, california based company with fully outsourced manufacturing in China. One thing that has been useful in my situation is developing an audit program where QA goes to suppliers and sub-suppliers annually and audits their entire QMS. Since you've been getting glimpses of their gaps, it sounds like you would know where to start during an audit.

I think this accomplishes two things. One, you gain a better understanding of the gaps and can work with the supplier to improve it. Like other's have mentioned, using the third party that accredited their certs as leverage is good and backing it up with specific clauses they're not compliant with in a formal audit report is even better.

Second, the supplier realizes that they will be under routine scrutiny for their entire operation, not just a batch or two. Hopefully this will motivate them to step up their game. The program could even be used to benchmark your current supplier against other potential suppliers in the future.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Very late response, but I'm in a similar situation, california based company with fully outsourced manufacturing in China. One thing that has been useful in my situation is developing an audit program where QA goes to suppliers and sub-suppliers annually and audits their entire QMS. Since you've been getting glimpses of their gaps, it sounds like you would know where to start during an audit.

I think this accomplishes two things. One, you gain a better understanding of the gaps and can work with the supplier to improve it. Like other's have mentioned, using the third party that accredited their certs as leverage is good and backing it up with specific clauses they're not compliant with in a formal audit report is even better.

Second, the supplier realizes that they will be under routine scrutiny for their entire operation, not just a batch or two. Hopefully this will motivate them to step up their game. The program could even be used to benchmark your current supplier against other potential suppliers in the future.
This is a good example of "the deeper QA toolbox" I mentioned earlier, but again - it doesn't come without a cost, and the return is not guaranteed upfront and is sure not immediate.
 
Thread starter Similar threads Forum Replies Date
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
F Supplier Quality Assurance Job Openings - 8/2020 Job Openings, Consulting and Employment Opportunities 0
C Quality assurance in Pharmacovigilance Document Control Systems, Procedures, Forms and Templates 0
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Independence of DQA (Design Quality Assurance) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Pancho Definition Quality Assurance Program - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
chris1price MDR Conformity Assessment for a Class 2a device - Production Quality Assurance EU Medical Device Regulations 2
L Definition Mini Builds - Quality Assurance Terms and Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
Marc Adventures in Design Quality Assurance - Two-week-old Pixel 2 XL displays World News 0
P Quality Assurance and Quality Control - Which clauses of ISO 9001 deal with each? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A KPI for Quality Assurance Team in a Service Oriented Industry Service Industry Specific Topics 8
C I'm starting my Career in Quality Assurance Career and Occupation Discussions 8
E Employees in Quality Assurance Jobs Career and Occupation Discussions 2
Y Outsourced aerospace work quality assurance? Supplier Quality Assurance and other Supplier Issues 6
R Quality Assurance Assessment of the F-35 Lightning II Program AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Quality Assurance in an Architectural firm Misc. Quality Assurance and Business Systems Related Topics 3
M QAM (Quality Assurance Matrix) for a sterilization process Quality Tools, Improvement and Analysis 1
S Quality Assurance Plan template for CNC Milling Industry AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A Career Path Options for Quality Assurance Engineer in Roads & Infrastructure Field Career and Occupation Discussions 2
C Quality Assurance Manager ? Next Steps? Quality Manager and Management Related Issues 10
S Quality Assurance Manager involvement in Management Review AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
R Quality Assurance/Quality Control in Education Consultacy Service Industry Specific Topics 14
E Use of Certified Reference Materials for Quality Assurance General Measurement Device and Calibration Topics 6
Q Quality Objectives for Quality Control and Quality Assurance functions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Using Exact Words from ISO 9001:2008 in Level 1 Document (Quality Assurance Manual) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
S Implementing a Quality Assurance Program Service Industry Specific Topics 3
J Appliance Manufacturing - Quality Assurance Mentor Wanted Career and Occupation Discussions 13
A Incoming Material Quality Assurance Cell Document Control Systems, Procedures, Forms and Templates 4
M Bachelor Degrees in Quality Management or Quality Assurance Career and Occupation Discussions 3
M How to be a good Quality Assurance Engineer Career and Occupation Discussions 6
M Designing a Quality Assurance and Control System Quality Manager and Management Related Issues 3
J Resistance to Change as a Master Thesis in Quality Assurance Professional Certifications and Degrees 7
P Definition Quality Control vs Quality Assurance - Differences or Semantics Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 26
A Quality Assurance Stamps and Supplies for Certifying Product Misc. Quality Assurance and Business Systems Related Topics 2
E Full Quality Assurance Certificate EU Medical Device Regulations 5
P Why does a SQA (Software Quality Assurance) standard be implemented in our company Software Quality Assurance 4
M The System engineering procedures is it considerd as Quality Assurance Procedurcs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M QA (Quality Assurance) Monthly Report for Repaired Pallets Document Control Systems, Procedures, Forms and Templates 2
Z Quality Assurance Plan for Engineering Service Industry Quality Manager and Management Related Issues 1
P Level 5 CQI Diploma in Quality (Assurance and Management) Covegratulations 7
M New appointment as Quality Assurance Executive - Job Scope Career and Occupation Discussions 3
I Quality Assurance Business Plan & Strategy Quality Tools, Improvement and Analysis 3
E Responsibilities of a QA (Quality Assurance) Inspector Career and Occupation Discussions 5
P What is the last revision of Toyota SQAM (Supplier Quality Assurance Manual)? Customer and Company Specific Requirements 3
A Suggest Computer Aided Quality Assurance (CAQ) software for Medical Devices Quality Assurance and Compliance Software Tools and Solutions 3
N Customer Service/Inside Sales Will Not Leave Us (Quality Assurance) Alone! Document Control Systems, Procedures, Forms and Templates 3
J Rejection during Sampling Inspection (Outgoing Quality Assurance) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
P Boeing D6-51991 Quality Assurance Standard for Digital Product Definition AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
K Why Quality Assurance is Unique Misc. Quality Assurance and Business Systems Related Topics 8
N Horoscopes for Quality Assurance professionals? Funny Stuff - Jokes and Humour 0

Similar threads

Top Bottom