Title Page
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Conducted on
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Auditor
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Location
Manufacturing Control Plan
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Does the factory have production flow diagrams identifying appropriate quality control points?<br><br>Check Point: <br>1. MCP/Rencana Mutu<br>2. Flow Process
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Does the factory execute an appropriate manufacturing control plan including process monitoring, quality controls, and internal testing for all product categories?<br><br>Check Point: <br>1. MCP/Rencana Mutu<br>2. Kalibrasi alat ukur<br>3. Sample & FRA<br>4. SOP
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Are there documents and records to support the manufacturing control plan is being executed?<br><br>Check Point : <br>1. PQC Checklist<br>2. TPM & 5R Checklist<br>3. RHHP
Product Development
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Does the factory effectively execute a pre-production process for their product categories? <br><br>Check Point : <br>1. FMEA<br>2. Serah terima Pre Production - Production<br>3. Manufacturing Variability (MV)
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Does the factory have a pre-production process with both QC and Production represented?<br><br>Check Point : <br>1. FMEA <br>2. MOM Meeting Pre Production <br>3. Daftar Hadir
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Are shade bands created and maintained?<br><br>Check Point : <br>1. Shade Band<br>2. Shade band monitoring and maintenance checklist
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Is there a documented process requiring client approval when changing materials, components, design, or manufacturing processes? <br><br>Check Point : <br>1. Prosedur ECN <br>2. Doc. ECN & Doc. Approval by Customer
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Are there documents and records of client approvals acquired when materials, components, design, or manufacturing processes change?<br><br>Check Point : <br>1. Procedure ECN<br>2. Approval Customer<br>3. ECN Traceability
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Are risk based assessments conducted on the product and manufacturing systems, and reviewed during the pre-production process?<br><br>Check Point : <br>1. Interview random sampling <br>2. FMEA<br>3. MV<br>4. Shade Band
Supplier Management
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Does the factory have a process to approve suppliers for incoming products, materials, and services?<br><br>Check Point : <br>1. PS.15 - Kualifikasi dan Evaluasi Supplier<br>2. PS.16 - Audit Supplier atau Pemasok<br>2. Daftar Supplier Terpilih<br>3. Form Supplier Survey<br>4. Audit SupplieR
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Does the factory have a process to ensure incoming raw materials and/or sub-assemblies conform to US Safety and Regulatory requirements?<br><br>Check Point : <br>1. PS.50 - Restricted Substances (BOS)<br>2. COA<br>3. MSDS
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Does the factory have a process to ensure incoming raw materials and/or sub-assemblies conform to specifications and quality standards?<br><br>Check Point :<br>1. PS.20 - Penerimaan Barang sampai dengan penyimpanan<br>2. Sertifikat Analisa/COA<br>3. Incoming Checklist
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Are there documents or records to support that incoming raw materials, components, and/or sub-assemblies conform to product specifications, quality standards, and US Safety and Regulatory requirements? <br><br>Check Point : <br>1. Incoming Checklist<br>2. Acuan Kerja Incoming
Production Control
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Are work instructions appropriate and executed for each production operation?<br><br>Check Point : <br>1. Acuan Kerja
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Does the factory compare first production units to client approval samples and/or specifications?<br><br>Check Point : <br>1. Sample<br>2. First Running Approval (FRA)
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Does the factory have defect samples in the production area or use a list of specific defects in their quality checks? <br><br>Check Point : <br>1. Contoh defect di setiap proses<br>2. Visual defect<br>3. Kode reject semua proses
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Does the factory conduct INLINE inspections?<br><br>Check Point : <br>1. PQC<br>2. Inspection Checklist
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Does the factory conduct END OF LINE inspections?<br><br>Check Point :<br>1. PQC<br>2. Full Lot Inspection (report)
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Are there documents or records to support INLINE and END OF LINE inspections are conducted?<br><br>Check Point : <br>1. PQC<br>2. Full lot Inspection<br>3. Pencatatan pengukuran parameter
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Are quality processes effectively executed on all production shifts?<br><br>Check Point : <br>1. Memo internal quality<br>2. Memo kehadiran QC saat Produksi<br>3. Full Lot Inspection (report)
Equipment & Maintenance
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Does the factory validate that the equipment settings are appropriate at line start-up and for any product /style changeover?<br><br>Check Point : <br>1. Acuan Kerja Change Over<br>2. Doc. Serah Terima (Per shift)<br>
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Does the factory execute a preventative maintenance schedule for all production and facility equipment which is critical to product safety and quality? <br><br>Check Point : <br>1. TPM/AM<br>2. Kalibrasi alat ukur di Produksi<br>3. Checklist AM
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Are corrective actions taken if the equipment is found to be operating outside specified tolerances and/or limits?<br><br>Check Point : <br>1. Data perbaikan mesin<br>2. Form-Historical Machine
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Has all measurement and test equipment been calibrated? <br><br>Check Point : <br>1. Jadwal Kalibrasi<br>2. Sertifikat Kalibrasi
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Are AC powered products being produced in this factory tested per the requirements from a recognized third party Safety Agency?<br><br>Check Point : <br>1. Light Box (Lampu D65)<br>2. TPM Light Box
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Does the factory review product and packaging material in a calibrated light box with the Target and/or client required light source?<br><br>Check Point : <br>1. Light Box (Lampu D65)<br>2. TPM Light Box
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Are tools, spare parts, fixtures, jigs, molds, etc. appropriately stored to avoid damage and deterioration?<br><br>Check Point : <br>1. Penataan tooling/jig<br>2. Checklist monitoring dan controlling <br>3. Min Max Inventory/ Locator System
Training
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Does the factory identify and execute training requirements for production and quality workers as defined by job role?<br><br>Check Point : <br>1. Jadwal/Matrix Training<br>2. Materi Training <br>3. Training Orientasi Karyawan Baru<br>4. Training Quality & Produksi<br>5. Pre Post Test
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Are QC and production workers trained and calibrated on how to identify defects?<br><br>Check Point : <br>1. Kurikulum Training<br>2. Training Kalibrasi
Quality Management System
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Are measurable quality goals identified and actual performance results collected?<br><br>Check Point : <br>1. Sasaran Mutu/KPI
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Is the traceability system effective from the source of raw material and components through the finished product?<br><br>Check Point : <br>1. Traceability
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Does the factory have a process for control of non-conforming materials to effectively identify, segregate, and disposition non-conforming products?<br><br>Check Point : <br>1. AK-QA-PRS-18 - Penyelesaian Hold<br>2. Segregasi Area
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Are there documents and records to support execution of the control of non-conforming materials process?<br><br>Check Point : <br>1. AK-QA-PRS-18 - Penyelesaian Hold<br>2. F.91 - Laporan Data Hold Product
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Does the factory ensure that any reworked non-conforming materials have been re-inspected?<br><br>Check Point : <br>1. AK-QA-PRS-18 - Penyelesaian Hold<br>2. Label Identitas<br>3. Segregasi Area
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Does the factory have a documented corrective action process for the investigation & resolution of nonconforming product? <br><br>Check Point : <br>1. PS.27 - Tindakan Perbaikan<br>2. Form CAPA
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Does the factory take corrective actions based on results from previous inspections, non-conforming materials in production, and client feedback?<br><br>Check Point : <br>1. CAPA<br>2. Monitoring CAPA
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Does the factory execute a corrective action process with investigation and resolution for nonconforming products?<br><br>Check Point : <br>1. CAPA<br>2. Monitoring CAPA
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Does the factory conduct critical safety testing for all product categories?<br><br>Check Point : <br>1. Test BV<br>2. Test Internal GCP<br>3. MCP
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For wood, leather, rubber, rubber/latex coated and natural material products, is the moisture content of the product measured, and the relative humidity/ temperature of the storage area controlled?<br><br>Check Point : <br>1. MCP<br>2. Checklist Kelembaban<br>3. AK INC & OG
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Does the factory conduct final inspections?<br><br>Check Point : <br>1. Final Inspection
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Are there documents or records to support final inspections are conducted?<br><br>Check Point : <br>1. Full Lot Inspection
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Is there management commitment, oversight, and actions taken to evaluate the quality system using quality goals and key performance indicators? <br><br>Check Point : <br>1. Sasaran Mutu/KPI<br>2. Management Review
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Did the 20 Piece workmanship audit pass?<br><br>Check Point : <br>1. Internal Audit untuk pengecheckan proses sesuai requirement Target<br>2. PQC
Site Conditions
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Is the facility clean and organized?<br><br>Check Point : <br>1. 5R/5S
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Does the facility have sufficient lighting?<br><br>Check Point : <br>1. Penerangan Area (Lux Meter)
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Is the facility well ventilated?<br><br>Check Point :<br>1. 5R/5S
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Are building/facility conditions properly maintained to prevent mildew/mold growth?<br><br>Check Point : <br>1. Prosedur pengendalian jamur<br>2. Stadarisasi Pallet<br>3. Standarisasi peletakan Raw Material & FG<br>4. Checklist Humidity
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Are raw materials and finished goods appropriately stored to avoid damage and deterioration?<br><br>Check Point : <br>1. FIFO System <br>2. FG tidak boleh diletakkan di luar ruangan <br>3. FG disimpan di lantai, jauh dari dinding pada palet atau rak dan ditutup untuk mencegah debu / kotoran terpapar (jika perlu).<br>4. FG harus kering dan tidak boleh basah atau rusak.
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Are client-branded packaging materials and labels secured and in good condition?<br><br>Check Point : <br>1. In-store area<br>2. Logbook <br>3. Monitoring stock
Process Control
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Is there a process that defines how documentation and records are controlled, including current version, accessibility, and proper disposal? <br><br>Check Point : <br>1. PS.01 - Pengendalian Dokumen<br>2. PVP
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Does the factory properly store, protect, update, and dispose of quality documentation and records?<br><br>Check Point : <br>1. PS.01 - Pengendalian Dokumen<br>2. PVP<br>3. Final-Iso
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Are ongoing Quality Control (QC) meetings held at the factory in which Production is represented and quality topics discussed?<br><br>Check Point : <br>1. Quality Meeting
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Does the QA (Quality Assurance) or QC (Quality Control) department operate separately from the Production Department?<br><br>Check Point : <br>1. SO All Department <br>2. SO Quality
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Is there a documented process to show that clients are notified immediately on issues of product safety or regulatory non-compliance? <br><br>Check Point : <br>1. PS.20 - Penanganan Keadaan Tidak Terduga<br>2. AK/QMR/01- Penanganan Keadaan Tidak Terduga