Indentifying human error as a root cause

#1
This is my 1st post and I hope I have it in the right forum.

We’re a sub contract assembly manufacturer and we make various PCBA’s and assembly enclosures for all industries.

I’m struggling to identify the route cause for operators missing the fitting of some conventional parts during assembly (Resistors, Diodes, Capacitors etc) This may only be one component here and there but these also being missed during the inspection process.

All the operators and inspectors are experienced. (IPCA-610 & J-STD) yet PCBA’s with defects are getting dispatched to our customers. Further to this, the defects are not isolated to any particular customer or assembly. Although, I have narrowed it down to two operators and one inspector.

Once these assemblies get dispatched it can be a month or two before we are informed of the defects making it difficult to identify the route cause.

All documentation in relation to the job is correct and clearly detailed. Which leaves human error, something I don’t like recording this as a route cause. There are several human factors that could be the cause of the defects, Inattentiveness, Fatigue, Distraction, Rushed, Habit, Stress or even all of these.

How can I overt these issues when I can’t pint point the exact root cause?
 
Last edited:
Elsmar Forum Sponsor
#5
We use Automated optical inspection mainly for surface mount components, but the AOI had limited internal height restricting its use for through hole components.

Using an AOI would'nt help prevent the the operator not fitting the part in the 1st place. This would only assit in finding the defect.
 
#6
Using an AOI would'nt help prevent the the operator not fitting the part in the 1st place. This would only assit in finding the defect.
I agree with you.
The approach is to first arrest the defective from going out of your gate.
Then the result of the AOI can help in indicating the place where such errors happen.
Then it is a case of building competency, reducing the component load per operator, or anything else best suited to your context.
but the AOI had limited internal height restricting its use for through hole components.
This is a constraint of your AOI which has to be addressed to meet to your requirements.
Good Luck
 

John Predmore

Trusted Information Resource
#7
There is ongoing discussion here at Elsmar Cove about human error as root cause. I liked the HERCA worksheet shared recently by
Johnnymo62 that allows root cause investigation to go deeper than blaming the operator. Many times, experienced operators make errors because of distractions, and improvements in workplace layout and work environment policy can go far to minimize distractions and errors.

You asked how to pin-point what happened when the error is discovered weeks later. You could, as a temporary measure, do audits or added inspection, and try to catch errors closer to the point in time when they are created. Depending on the culture in the workplace, you could ask downstream workers to "inspect" each PCBA before they accept it, at least look for the Top 10 most common problems. You could ask workers to keep a log, date and time when their workflow is interrupted by distractions. In order not to become too "big-brother"ish, maybe keep the logbooks private until there is a specific problem incident discovered, then explain you are trying to correlate a specific failure occurrence on a specific day and time to a specific root cause. Good Luck. Let us know if you find a solution that works!
 

Sidney Vianna

Post Responsibly
Leader
Admin
#8
1. Ask the operators what could be done to ameliorate the situation. Without blame, engage the people directly involved with the work and do not isolate them from the problem potential root causes and possible solutions.

2. Assign the kits with very precise quantity of components for the hand-assembled, through hole pieces. If there are 2 resistors left after assembly, you know they were not installed on a board.

3. How are the defects identified downstream at the customer? A functional test? Replicate the method at the end of your line. Many times the customer will assign a test fixture to a supplier exactly to identify problems early on and upstream of their lines.

Good luck.
 

outdoorsNW

Quite Involved in Discussions
#9
You may need a better AOI machine. Some are better than others at handing tall parts.

Also, can electrical test detect the missing components? I know not all nets are testable. Again a better machine can test difficult boards that a less capable machine cannot.
 

Ninja

Looking for Reality
Trusted Information Resource
#10
It may also help to pre-measure part quantities.
If they have to mount 34 resistors, 22 diodes and 16 caps...and that's what they have...if they have any left over, they know they missed something before AOI even gets run...
Is this an option?

Also, since it is circuitry we're talking about, electrical testing can determine open circuits because a resistor is missing, or a cap missing. can the right leads and probes be identified to do this testing?
 
Thread starter Similar threads Forum Replies Date
B Human error corrective action 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
I ANDA Human Factors Guidance US Food and Drug Administration (FDA) 0
shimonv Where do you place Human Factors report in a 510(k) application? Other US Medical Device Regulations 3
K HR concerns with listing human factors as root cause Problem Solving, Root Cause Fault and Failure Analysis 11
Y Human Grading SW EU Medical Device Regulations 2
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 17
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
M HR (Human Resources) based software recommendations Human Factors and Ergonomics in Engineering 2
H Human Resources Process Document Control Systems, Procedures, Forms and Templates 2
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
M Informational EU – Meeting minutes – Competent Authorities on Substances of Human Origin Expert Group Medical Device and FDA Regulations and Standards News 0
M Informational UK – Contingency legislation covering regulation of medicines and medical devices in a no deal scenario – Human Medicines and Medical Devices (Amendm Medical Device and FDA Regulations and Standards News 3
J Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens Other Medical Device and Orthopedic Related Topics 1
M Informational Technology and innovation of human implants | Panel for the Future of Science and Technology (STOA) | European Parliament Medical Device and FDA Regulations and Standards News 0
J0anne Implantable Devices - The effects of surgical scaffold implanted into the human body Other Medical Device and Orthopedic Related Topics 8
M What is required to run human clinical trials in France EU Medical Device Regulations 9
M Informational USFDA Final Rule – Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices Medical Device and FDA Regulations and Standards News 0
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
S Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness ISO 13485:2016 - Medical Device Quality Management Systems 13
S Is Human Factor Testing required as part of Design Control Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Interesting Discussion Human Factors as Root Cause AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
P Global medical device human factors/usability requirement IEC 62366 - Medical Device Usability Engineering 3
Sidney Vianna ISO/TS 30411:2018 Human resource management - Quality of hire metric Other ISO and International Standards and European Regulations 1
P Interesting Discussion Addressing Human Factors in Corrective Action AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 23
M Nanomaterials? Products based on human cell or tissue derivatives? EU Medical Device Regulations 7
S Medical Devices incorporating human tissues EU Medical Device Regulations 1
S ISO 13485 Cl. 6.2 Human Resources - Personnel working within the QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
Colin Pressure Vessels for Human Occupation (PVHO) Various Other Specifications, Standards, and related Requirements 4
H Certification for Indoor Human-Robot Collaboration Safety Positioning System Human Factors and Ergonomics in Engineering 4
T Human Error vs Technique Root Cause (Categories) Human Factors and Ergonomics in Engineering 9
D How to Monitor Suppliers for Human Trafficking AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T New EU Medical Device Regulations - Q1/2 2017 and Human Factors Other Medical Device Related Standards 10
C Clinical Requirements for HO (Human Organ) Medical Devices EU Medical Device Regulations 10
K Poka-Yoke for Quantity Shortage caused by Human Error Quality Tools, Improvement and Analysis 7
O Acceptance criteria bacterial endotoxins immunosera for human use Manufacturing and Related Processes 3
M New MHRA guidance on Human Factors - Usability Engineering IEC 62366 - Medical Device Usability Engineering 1
L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
Marc Personnel Department to Human Resources Department - Changes over Time Career and Occupation Discussions 1
S IEC 62366 vs. FDA Human Factors Requirements Human Factors and Ergonomics in Engineering 2
S Human Factor Summative Study Class III Device RA Checklist wanted Human Factors and Ergonomics in Engineering 2
M Auditing Human Resources and Finance Departments ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P GS1 NHRN AIs - Creating Barcodes for Human Product Other ISO and International Standards and European Regulations 4
N Non-conformances due to Human Error Nonconformance and Corrective Action 64
P Japan Requlatory Requirement for Nerve Scaffold using Human Tissue Japan Medical Device Regulations 2
P EU Requlatory Requirements for Nerve Scaffold using Human Tissue EU Medical Device Regulations 2
M Human Factors Testing for CE Marking of a Cosmetic Device CE Marking (Conformité Européene) / CB Scheme 9
9 Ideas for reducing Human Error during Order Receipt Quality Manager and Management Related Issues 4
D Auditing Human Resources (ISO 9001) Internal Auditing 11
J Corrective Action Process and Human Error ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom