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Wenda QC Presentation.master
 

Wenda QC Presentation.master

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Quality Control Presentation.

Quality Control Presentation.

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    Wenda QC Presentation.master Wenda QC Presentation.master Presentation Transcript

    • Wenda Ingredients Quality Assurance Program “ Wenda America Delivers First Class Quality”
      • Brent McLean
      • Senior Sales & Marketing Manager
      • Wenda America
      • Orders (847) 803-5110
      • Cell (608) 513 - 4415
      • Wenda began in 1995 as the first generation of privately owned Food Industry business in China.
      • ________________________________________________
      • Wenda developed a leadership position to supply a wide array of food ingredients from China / Asia to
      • the global marketplace.
      • ________________________________________________
      • Wenda started a leadership program to implement the highest standards of quality with food ingredient manufacturers in China.
      • Wenda was a leading Chinese company to educate and and partner with manufacturers in the use of QA standards such as GMP’s and HACCP.
      • ________________________________________________
      • Wenda’s position as a Leader in quality control assisted Chinese manufacturers in compliance with FCC, USP, BP and EP monographs for specifications and analytical methods.
    • WENDA’S Quality Assurance Program
    • WENDA’S Quality Assurance Program
      • Quality Target : creates identifiable goal to qualify products.
      • Three SOP’s : guarantee the target is met .
      • 1. SOP = Supplier Approval
      • 2. SOP = Quality Control
      • 3. SOP = Customer Complaints & Claims Handling
      • Labs and Team : investment in modern analytical labs, equipment, instrumentation and professional personnel to perform the QA / QC system requirements.
    • WENDA’S Quality Assurance Program Quality Target: Product Quality Product Qualification Rate : a 99 + % approval of delivered product meeting the specification agreed between the customer and Wenda.
    • WENDA’S Quality Assurance Program First SOP – Supplier Approval
      • Evaluate Supplier’s product specification and test methods:
        • a. Pharmacopoeia monographs.
        • b.Wenda’s specification.
        • c.Customer’s specification.
      • WENDA’S Quality Assurance Program
      • First SOP - Supplier Approval
      2. Inspect Supplier SOP and batch records: On-site audits of batch records to insure traceability of the product. 3. Evaluate Sanitary, Safety and Environmental Issues: This step verifies the production system is under a closed and sanitary condition, with pest control apparatus in place, appropriate equipment in place and trained personnel are present.
      • WENDA’S Quality Assurance Program
      • First SOP - Supplier Approval
      4) Observe Workers Quality Consciousness: Observation of employee training, attitudes and behaviors to check if workers are serious about their responsibilities, their performance of test procedures and overall attitude. 5) Repetitive Audits: The purpose of this step is to monitor previous steps 1-4 to ensure consistent quality products are supplied by the manufacturers.
      • WENDA’S Quality Assurance Program
      • Second SOP – Quality Control
      1) Product Code: Every different product specification designates a unique product code to avoid mistakes and to ensure traceability. 2) SAP / ERP System: Wenda’s system ensures implementation of product codes and their utilization throughout the various business operations.
      • WENDA’S Quality Assurance Program
      • Second SOP – Quality Control
      3) Pre-shipment inspection at port or facility: a. Standard Inspection: package, marks, batch #, stack. The supplier class A,B,C determines the level & extent of test audit. b. Random Sample Analysis: test by Wenda lab or independent third party.
      • WENDA’S Quality Assurance Program
      • Third SOP – Customer Complaints & Claims Handling
      1. Identification & evaluation of non-conformity: a. Collecting data & information b. Representative sample tests c. Identify out of specification material
      • WENDA’S Quality Assurance Program
      • Third SOP – Customer Complaints & Claims Handling
      2) Corrective and Preventive Action
      • Corrective and Preventive Action: a. Recall product(s) identified b. Correcting & re-qualify suppliers c. Intensify quality control d. Verify the effect e. Reclassify the supplier
    •  
      • WENDA’S Quality Assurance Program
      • Labs and Team
      • Wenda Business Team: a. Good communication skills b. Well-educated in food & pharma sciences, QA/QC programs c. Wenda practices with quality and safety consciousness
      • WENDA’S Quality Assurance Program
      • Labs and Team
      2. QA / QC Team: a. Professional & certified in QA / QC b. Advanced training & extensive education in GMP, HACCP, ISO-9001, etc… c. Experienced and innovative analysts specializing in food, chemical and microbiological analysis.
      • WENDA’S Quality Assurance Program
      • Labs and Team
      • 3. Responsibilities of QA/QC team :
      • QA/QC Director:
      • a. Setup, maintenance and improvement of ISO9001, GMP, HACCP
      • b. Supervision of QA/QC
      • c. Supervision of SAP ERP system
      • d. Responding to customer complaints & claims
      • Senior QA Engineer:
      • a. Documentation including specification, MSDS, COA, archives
      • b. Technical support & service
      • c. Arrangement of QC work
      • d. Sample management
      • e. Supplier approval
      • WENDA’S Quality Assurance Program
      • Labs and Team
      • Responsibilities of QA/QC team :
      • Senior QC Engineer:
      • a. Management of chemical analysis & microbial laboratories
      • b. Arrangement and implementation of sample tests
      • c. Supplier Visits/Audits
      • Chemical Analyst:
      • a. Chemical Analysis
      • b. Instrumental Analysis
      • Microbial Analyst:
      • WENDA’S Quality Assurance Program
      • Labs and Team
      • Responsibilities of QA/QC team :
      • On-site QC Inspectors at Chinese main ports:
      • a. Inspection of products
      • b. Sampling and testing
      • WENDA’S Quality Assurance Program
      • Labs and Team
      4) Chemical Analysis Laboratory : Primary Analysis Apparatus & Instrument - HPLC - UV - Automatic Polarimeter - Drying Oven - Digital Drying Oven - Vacuum Drying Oven - Muffle Furnace - Digital Rotary Viscometer - Automatic Potentiometric Titrator - pH meter - Conductimeter - Automatic Vibrating Sieve - Azotometer
      • WENDA’S Quality Assurance Program
      • Labs and Team
      5) Microbial Analysis Laboratory
      • 5) Microbial Analysis Laboratory:
      • a. Common microbial analysis
      • b. Fast Thin Film analysis accepted by FDA, ASTM, AOAC etc
      • Third-party Laboratories:
      • a. SGS
      • b. Chinese Science Academy- Dalian Chemical & Physical Institute
      • c. Chinese Commodity Inspection & Quarantine Bureau
      • d. Quality Inspection & Test Institute
      • e. Other labs of famous University and Science Institutes
    •