Quality Management

Man, Machine, Material, Method, Measurement, Environment · Full-process quality control · Zero defect as the goal

Strive for excellence, continuous improvement; customer needs-oriented, zero defect as the goal, establish a quality culture with full participation, and provide customers with consistent high-quality products and services.

Material nonconformity rate

>98%

In-process yield rate

>99.5%

Outgoing shipment pass rate

0.5%

Customer complaint rate

>1.67

Critical characteristic CPK

99.8%

On-time delivery rate

Quality Management System Overview — Man, Machine, Material, Method, Measurement, Environment (5M1E)

BRM Metal has established a comprehensive quality management system centered on Man, Machine, Material, Method, Measurement, Environment (5M1E). From raw material incoming to finished product outgoing, full-process quality control covers the dual process chains of MIM metal injection molding and MBJ metal 3D printing, meeting the differentiated quality requirements of customers in automotive, medical, consumer electronics, aerospace and other industries.

Man

Company-wide quality awareness training, key positions require certification. The quality team covers four functions: IQC, IPQC, FQC, OQC, with regular skill assessments and certifications.

Company-wide TQM quality training system
Certified operators for key processes
Quality engineers with specialized CPK/SPC capabilities

Machine

Core equipment includes German imported continuous sintering furnaces, Japanese Nissei injection molding machines, Zeiss CMM, etc., with Class 100,000 cleanroom. Annual calibration + preventive maintenance (PM) plan, MSA measurement system analysis with GR&R < 10%.

Overall Equipment Effectiveness (OEE) monitoring
Safety stock management of key spare parts
Equipment abnormality response < 2 hours

Material

In-house powder making + 100% spectral analysis of incoming materials, full inspection of powder particle size, apparent density, and flowability. 30+ material grades covering stainless steel, titanium alloys, soft magnetic alloys, and superalloys, RoHS/REACH compliant.

Material batch traceability to supplier heat number
Powder oxygen content controlled at < 1000 ppm
Feedstock flowability batch-to-batch variation < 5%

Method

APQP (Advanced Product Quality Planning) + PPAP (Production Part Approval Process) + SPC (Statistical Process Control), with critical dimension CPK > 1.67. Standardized Operating Procedures (SOP), precise recording and traceability of process parameters.

FMEA Failure Mode and Effects Analysis
Full coverage of Control Plan (CP)
8D problem solving + CAPA (Corrective and Preventive Action)

Environment

Class 100,000 cleanroom with temperature and humidity control, zone management for injection molding/printing/debinding/sintering. ESD anti-static measures, complete product protection and labeling traceability system.

Temperature 22±2°C · Humidity 45±10% RH
Positive pressure clean fresh air system
5S site management + visual management

Measurement

Precision inspection equipment including Zeiss CONTURA G2 CMM (±1.5μm), Keyence LM optical inspection (0.01mm), Shimadzu PDA spectrometer (ppm level), GOM ATOS blue light 3D scanner (±0.005mm), forming a complete measurement system.

MSA measurement system analysis with GR&R < 10%
Full dimension inspection + 3D scanning comparison
Annual gauge calibration · traceable to national standards

Quality Tools Matrix — Quality Weapons For Different Scenarios

From product development to mass production delivery, we match appropriate quality tools for different stages to ensure data support and method assurance in every step.

APQP advanced product quality planning

Scenario:New product introduction, MIM tooling development, MBJ prototyping to mass production transition

Quality planning is carried out at the project initiation stage, delivering Control Plan (CP), PFMEA, MSA plan, and SPC plan to ensure that quality risks are identified and controlled before mass production.

PPAP production part approval process

Scenario:Automotive customer mass production approval, engineering change validation

Submit PSW + full dimension report + material certificate + performance test + appearance approval. A Level 3 documentation package ensures the customer's full approval of production parts.

FMEA failure mode and effects analysis

Scenario:MIM tooling design review, new process introduction, customer complaint prevention

DFMEA (Design FMEA) + PFMEA (Process FMEA) to identify potential risks and formulate preventive actions. All items with RPN value > 100 are corrected.

SPC + MSA

Scenario:Mass production process monitoring, equipment capability verification, customer annual audit

SPC monitors critical dimensions in real time with CPK > 1.67. MSA ensures GR&R < 10%, guaranteeing reliable measurement data and sufficient process capability.

8D + CAPA

Scenario:Customer complaint handling, major internal abnormalities, supplier quality improvement

8D systematic problem solving + CAPA closed-loop for corrective and preventive actions. Response within 2 hours, containment within 24 hours, permanent corrective action within 7 days.

QRQC quick response quality control

Scenario:Rapid handling of production line abnormalities, daily quality morning meeting

Production line issues are immediately escalated, analyzed on-site, and decided quickly — problems never left overnight. Daily QRQC meetings review quality data from the previous 24 hours.

Four-Stage Inspection Process — IQC → IPQC → FQC → OQC

IQC incoming quality control

Full inspection of metal powder by spectral analysis (Shimadzu PDA-7000), particle size distribution, apparent density, and flowability. Binder batch verification. Sampling according to AQL standard, normal inspection level II.

✓ Incoming material pass rate>99%

IPQC in-process quality control

First article inspection + scheduled patrol inspection + parameter monitoring of key processes (injection molding / debinding / sintering). Real-time SPC with X-bar R control chart, CPK target > 1.33, critical characteristic > 1.67.

✓ In-process yield rate>98%

FQC final quality control

Zeiss CMM full dimension inspection + Keyence optical 100% appearance inspection + mechanical property (tensile/hardness/density) testing. Tightened inspection for critical characteristics, accompanied by full dimension inspection report.

✓ Outgoing shipment pass rate>99.5%

OQC outgoing quality control

Packaging integrity check + label/marking verification + appearance sampling + dimensional sampling + quantity check. Accompanied by outgoing inspection report + Certificate of Analysis (CoA) + RoHS/REACH compliance declaration.

✓ Customer complaint rate<0.5%

MIM parts undergo 15-20% volumetric shrinkage from injection molding to sintering. Process inspection focuses on monitoring green part weight and dimensions to ensure post-sintering precision is controlled. This is the core quality control aspect that distinguishes the MIM industry from traditional machining.

SPC Statistical Process Control — Data-Driven Quality Assurance

Implement SP Cin key MIM processes, using X-bar R control charts to monitor critical parameters such as injection weight, green part dimensions, and sintering shrinkage in real time. When the control chart shows abnormalities, OCAP (Out of Control Action Plan) is automatically triggered, with root cause analysis and correction completed within 2 hours.

Injection molding SPC

Monitor injection weight, injection pressure, and holding pressure to ensure green part consistency. Real-time data recording for each shot, batch-to-batch coefficient of variation < 1%.

MBJ printing SPC

Monitor powder spreading uniformity, binder saturation, and layer thickness deviation. Each printed layer is traceable, and critical parameters trigger automatic alarms.

Sintering process SPC

Monitor sintering temperature profile, holding time, and atmosphere flow rate. Sintering shrinkage is controlled within ±0.5%, batch CPK > 1.67.

CPK target

General characteristic CPK > 1.33, critical characteristic CPK > 1.67. A process capability analysis report is issued monthly; if trends show abnormalities, a continuous improvement project is initiated.

8D Problem Solving and Nonconforming Product Handling

When customer complaints or internal quality issues are identified, the 8D corrective action process is initiated within 2 hours, from problem description to permanent corrective action, with systematic closed-loop management. Nonconforming products are strictly handled according to the MRB (Material Review Board) process.

D1 establish team

Cross-functional team

D2 problem description

Clearly defined with 5W2H

D3 interim containment

Containment / segregation / sorting

D4 root cause analysis

5Why + Fishbone diagram

D5 permanent corrective action

Mistake-proofing design Poka-Yoke

D6 implementation & validation

Validate effectiveness with data

D7 prevent recurrence

Standardization + horizontal deployment

D8 team recognition

Lessons learned sharing

Common MIM quality defects (cracking, deformation, porosity) are typically related to debinding/sintering processes. During 8D analysis, focus on process parameter variations, and combine CT scanning with metallographic analysis to pinpoint root causes.

System Management & Document Control

A robust quality system documentation structure and record management system are the cornerstones of quality assurance. We have established a four-level documentation system in accordance with ISO 9001/IATF 16949/ISO 13485 standards, ensuring that every operation has a standard and every result is recorded.

Four-level documentation system

Level 1: Quality Manual — quality policy, objectives, organizational structure

Level 2: Procedure Documents — 25 documents covering the entire process

Level 3: Standard Operating Procedures (SOP) — standardized operations for each process

Level 4: Quality Record Forms — inspection reports, SPC data, audit records

Document control mechanism

• Approval process before document issuance (prepared → reviewed → approved)

• Only controlled versions are used on-site; obsolete versions are immediately retrieved

• Document changes require engineering change notice +customer confirmation

• External documents (customer drawings/standards) are in cluded incontrolled management

Record and traceability management

• Quality record retention period: Automotive 15 years, Medical 15 years, General 3 years

• Device History Record (DHR): complete production and inspection file for each batch

• Electronic record system: SPC data, CMM reports, spectral analysis automatically archived. Customers may request to review relevant batch quality files

Audit and continuous improvement

• Internal audit: 2 system audits + 4 process audits + 4 product audits per year

• Management review: annual management review meeting to evaluate achievement of quality objectives

• External audit: annual surveillance audit by certification body + customer on-site audit

• Layered Process Audit(LPA): verification at levels from team leader → supervisor → manager

Digital Quality Management — Full-Link Data-Driven from Incoming to Outgoing

From raw material warehousing to finished product outgoing, and then to continuous improvement feedback, we have deployed a full-link digital quality management platform to achieve real-time collection, visual monitoring, and intelligent early warning of quality data.

① Material receiving — digital incoming control

Raw materials are entered into the system upon arrival. Spectral analysis results areautomatically uploaded, and a unique traceability code is assigned to qualified batches. Powder particle size, apparent density, and flowability data are automatically judged for release. MIM powder is strictly managed on a FIFO First-In-First-Out basis according to shelf life, and the system automatically issues alerts when expiration approaches.

② Production — online quality dashboard

An electronic dashboard system is deployed in each process (injection molding / printing / debinding / sintering), displaying in real time: daily yield trend, SPC control chart (X-bar R), equipment OEE, critical dimension CPK, and abnormality alert information. Managers and customers can remotely view quality status with authorization.

③ Finished product outgoing — automated inspection and batch traceability

Keyence optical inspection is directly connected to the MES system. Inspection data is uploaded to the cloud in real time, automatically generating SPC reports and quality trend analysis. Each part can be traced within 30 minutes to: raw material heat number → powder batch → injection molding machine → debinding/sintering parameters → post-processing batch → inspection report.

④ Continuous improvement — data-driven quality enhancement

Quality data is aggregated into a central database, automatically generating monthly reports on: critical dimension CPK trends, defect Pareto analysis, supplier PPM ranking, and customer complaint trends. Abnormal data automatically triggers email/SMS alerts to quality engineers, driving the PDCA continuous improvement cycle.

Typical Defect Cases and Prevention/Control Solutions for MIM + MBJ

Based on 30+ years of accumulated MIM production experience, we have identified common quality defect patterns and established systematic prevention and control solutions.

Defect Type	Process Stage	Typical Appearance	Root Cause Analysis	Prevention/Control Solution
Sintering Cracking	MIM Debinding · Sintering	Surface or internal cracks on parts	Debinding rate too fast · Unreasonable heating curve	Optimize debinding heating curve · Stepwise heating · CT sampling after debinding
Dimensional Out of Tolerance	MIM Injection · Sintering	Dimensional deviation>±0.3%	Green part weight fluctuation · Abnormal sintering shrinkage	Injection weight SPC monitoring · First-piece weighing per shot · Shrinkage compensation formula
Surface Porosity	MIM Feedstock · Injection	Pinhole defects on surface	Feedstock containing gas · Injection speed too fast	Feedstock vacuum degassing · Optimize injection parameters · Mold venting design
Insufficient Density	MIM/MBJ Sintering	Relative density<95%	Insufficient sintering temperature · Short holding time	Sintering temperature profile validation · Density samples per furnace batch · Regular metallographic inspection
Poor Interlayer Bonding	MBJ Printing	Interlayer delamination · Low strength	Insufficient binder saturation · Uneven powder spreading	Quality monitoring of powder spreading per layer · Binder jetting consistency calibration
Deformation / Warpage	MIM/MBJ Sintering	Part warpage	Improper sintering support · Uneven cooling	Sintering fixture optimization · CFD simulation · Cooling gradient control

The above defect patterns have been incorporated into our PFMEA and process control plans. When launching new projects, engineers will conduct targeted risk assessments and develop customized prevention/control solutions. The continuously updated defect database provides data support for MIM and MBJ process optimization.

Quality Configurations and Audit Support for Customers in Different Industries

Quality management requirements for MIM/MBJ parts vary significantly across different industries. We provide customized quality documentation packages and professional audit support for customers in various industries.

Automotive industry

Quality system requirements:IATF 16949 certification, VDA 6.3 process audit, annual supplier audit

Document deliverables:PPAP Level 3 (PSW · PFMEA · CP · MSA · SPC · full dimensions · material · appearance approval), IMDS/CAMDS material data

Process capability:Critical characteristic CPK > 1.67 (customer-specified characteristics > 2.0), annual process audit score > 90%

Special requirements:Zero-kilometer defect target, advance notification for change management, 12-month quality guarantee for mass production parts

Automotive industry MIM solution →

Medical devices

Quality system requirements:ISO 13485 certification, process validation (IQ/OQ/PQ), ISO 10993 biocompatibility, cleanroom ISO 14644

Document deliverables:DHR (Device History Record), DHF (Design History File), UDI (Unique Device Identification), sterilization validation report

Process capability:100% full inspection for validation batches, CQA (Critical Quality Attribute) CPK > 1.33, annual sterilization revalidation

Special requirements:90-day advance notice for change management, batch record retention for 15 years, adverse event reporting mechanism

Medical Devices MIM solution →

Consumer electronics

Quality system requirements:ISO 9001 certification, AQL appearance sampling standard, RoHS/REACH environmental compliance, social responsibility audit

Document deliverables:full dimension inspection report + CPK data, CoA (Certificate of Analysis) material certificate, RoHS/REACH compliance declaration, limit sample sealing

Process capability:Class A appearance yield > 99%, Cpk > 1.33, MBJ rapid prototyping and validation in 3-5 days

Special requirements:ODM/JDM support, rapid NPI introduction, quarterly cost optimization

Consumer Electronics MIM solution →

Aerospace

Quality system requirements:AS9100D certification, Nadcap special process certification, ITAR compliance, first article inspection AS9102

Document deliverables:AS9102 FAI report, full traceability of material heat/lot numbers, NDT (Non-Destructive Testing) report, special process parameter records

Process capability:100% inspection of critical characteristics, Cpk > 1.67, batch-by-batch parameter validation for special processes, 15-year record retention

Special requirements:FAA/EASA airworthiness certification support, supplier DEA registration, cybersecurity NIST 800-171