Quality Management System
What is Quality Management System (QA、QC、TS)?
To ensure overall quality management, ACT quality management system is divided into three parts, namely QA quality assurance, QC quality control, TS technology service.
QA - Quality Assurance
According to fully running needs of GMP system, it can be divided into five work, including legal affairs, supplier quality audit and control, document system control, maintenance and supervision during production quality management, and material quality monitoring during storage and transport of material/ production intermediate goods/finish goods.
QC - Quality Control
Namely Detection and Identification Center. Through building strict and objective inspection techniques and methods of raw material, intermediate goods production and finish goods to inspection implementation, ensure the identification of quality effectiveness of any material and intermediate goods; ensure purity ,safety, effectiveness, uniformity and stability of any product entering the market.
TS - Technology Service
Through organizing technical experts to analyze specific issues or incidents including production, test, diagnosis and service in the company, and providing effective solutions and supervising their implementation, achieve technical breakthrough during production, test, diagnosis and service.
Nine principles of quality management
- Every management has system to conform to; every operation has SOP to depend on
- Implement strictly according to system and COP; do what one says
- All behaviors are based on testing
- Excellent product quality begins from excellent hardware design and maintenance
- Outstanding product comes from outstanding raw material
- Fine product comes from professional workers
- Uniform and stable product requires that every process is accurate and correct
- Regard mistake as the best learning opportunity; be good at regarding failures as a starting point of perfection
- “Width of 1mm, depth of 1 km”, pay attention to details and overall continuous improvement /li>
Six Quality Goals
- Purity and high safety of product
- High efficiency of product
- Uniformity and stability among batches
- Repeatability of production operation
- Quality traceability of
- Effective change management
Six Quality Tools
- Quality Complain Report
- PIP Performance Improvement Plan
- Miss-Operation Report
- Creative Proposal
- Change Management
- Validation System
ACT quality control system management process
1. Quality Plan
Set quality goals; identify who is customer; confirm customer’s needs; develop product features responding to customer’s needs. Develop processes which can produce products with such features; build process control measures; shift plans to implementation phrase.
2. Quality Control
Evaluate production actual performance; compare actual performance with quality target, and take actions on the difference.
3. Quality Improvement
Quality complaint report, PIP (preventive corrective measure), MOR (operation error report), creative proposal, change management, passport system