INTERNAL AUDIT - QAFA - SafetyCulture

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Manufacturing Control Plan

Does the factory have production flow diagrams identifying appropriate quality control points? Check Point: 1. MCP/Rencana Mutu 2. Flow Process
Does the factory execute an appropriate manufacturing control plan including process monitoring, quality controls, and internal testing for all product categories? Check Point: 1. MCP/Rencana Mutu 2. Kalibrasi alat ukur 3. Sample & FRA 4. SOP
Are there documents and records to support the manufacturing control plan is being executed? Check Point : 1. PQC Checklist 2. TPM & 5R Checklist 3. RHHP

Product Development

Does the factory effectively execute a pre-production process for their product categories? Check Point : 1. FMEA 2. Serah terima Pre Production - Production 3. Manufacturing Variability (MV)
Does the factory have a pre-production process with both QC and Production represented? Check Point : 1. FMEA 2. MOM Meeting Pre Production 3. Daftar Hadir
Are shade bands created and maintained? Check Point : 1. Shade Band 2. Shade band monitoring and maintenance checklist
Is there a documented process requiring client approval when changing materials, components, design, or manufacturing processes? Check Point : 1. Prosedur ECN 2. Doc. ECN & Doc. Approval by Customer
Are there documents and records of client approvals acquired when materials, components, design, or manufacturing processes change? Check Point : 1. Procedure ECN 2. Approval Customer 3. ECN Traceability
Are risk based assessments conducted on the product and manufacturing systems, and reviewed during the pre-production process? Check Point : 1. Interview random sampling 2. FMEA 3. MV 4. Shade Band

Supplier Management

Does the factory have a process to approve suppliers for incoming products, materials, and services? Check Point : 1. PS.15 - Kualifikasi dan Evaluasi Supplier 2. PS.16 - Audit Supplier atau Pemasok 2. Daftar Supplier Terpilih 3. Form Supplier Survey 4. Audit SupplieR
Does the factory have a process to ensure incoming raw materials and/or sub-assemblies conform to US Safety and Regulatory requirements? Check Point : 1. PS.50 - Restricted Substances (BOS) 2. COA 3. MSDS
Does the factory have a process to ensure incoming raw materials and/or sub-assemblies conform to specifications and quality standards? Check Point : 1. PS.20 - Penerimaan Barang sampai dengan penyimpanan 2. Sertifikat Analisa/COA 3. Incoming Checklist
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? Check Point : 1. Incoming Checklist 2. Acuan Kerja Incoming

Production Control

Are work instructions appropriate and executed for each production operation? Check Point : 1. Acuan Kerja
Does the factory compare first production units to client approval samples and/or specifications? Check Point : 1. Sample 2. First Running Approval (FRA)
Does the factory have defect samples in the production area or use a list of specific defects in their quality checks? Check Point : 1. Contoh defect di setiap proses 2. Visual defect 3. Kode reject semua proses
Does the factory conduct INLINE inspections? Check Point : 1. PQC 2. Inspection Checklist
Does the factory conduct END OF LINE inspections? Check Point : 1. PQC 2. Full Lot Inspection (report)
Are there documents or records to support INLINE and END OF LINE inspections are conducted? Check Point : 1. PQC 2. Full lot Inspection 3. Pencatatan pengukuran parameter
Are quality processes effectively executed on all production shifts? Check Point : 1. Memo internal quality 2. Memo kehadiran QC saat Produksi 3. Full Lot Inspection (report)

Equipment & Maintenance

Does the factory validate that the equipment settings are appropriate at line start-up and for any product /style changeover? Check Point : 1. Acuan Kerja Change Over 2. Doc. Serah Terima (Per shift)
Does the factory execute a preventative maintenance schedule for all production and facility equipment which is critical to product safety and quality? Check Point : 1. TPM/AM 2. Kalibrasi alat ukur di Produksi 3. Checklist AM
Are corrective actions taken if the equipment is found to be operating outside specified tolerances and/or limits? Check Point : 1. Data perbaikan mesin 2. Form-Historical Machine
Has all measurement and test equipment been calibrated? Check Point : 1. Jadwal Kalibrasi 2. Sertifikat Kalibrasi
Are AC powered products being produced in this factory tested per the requirements from a recognized third party Safety Agency? Check Point : 1. Light Box (Lampu D65) 2. TPM Light Box
Does the factory review product and packaging material in a calibrated light box with the Target and/or client required light source? Check Point : 1. Light Box (Lampu D65) 2. TPM Light Box
Are tools, spare parts, fixtures, jigs, molds, etc. appropriately stored to avoid damage and deterioration? Check Point : 1. Penataan tooling/jig 2. Checklist monitoring dan controlling 3. Min Max Inventory/ Locator System

Training

Does the factory identify and execute training requirements for production and quality workers as defined by job role? Check Point : 1. Jadwal/Matrix Training 2. Materi Training 3. Training Orientasi Karyawan Baru 4. Training Quality & Produksi 5. Pre Post Test
Are QC and production workers trained and calibrated on how to identify defects? Check Point : 1. Kurikulum Training 2. Training Kalibrasi

Quality Management System

Are measurable quality goals identified and actual performance results collected? Check Point : 1. Sasaran Mutu/KPI
Is the traceability system effective from the source of raw material and components through the finished product? Check Point : 1. Traceability
Does the factory have a process for control of non-conforming materials to effectively identify, segregate, and disposition non-conforming products? Check Point : 1. AK-QA-PRS-18 - Penyelesaian Hold 2. Segregasi Area
Are there documents and records to support execution of the control of non-conforming materials process? Check Point : 1. AK-QA-PRS-18 - Penyelesaian Hold 2. F.91 - Laporan Data Hold Product
Does the factory ensure that any reworked non-conforming materials have been re-inspected? Check Point : 1. AK-QA-PRS-18 - Penyelesaian Hold 2. Label Identitas 3. Segregasi Area
Does the factory have a documented corrective action process for the investigation & resolution of nonconforming product? Check Point : 1. PS.27 - Tindakan Perbaikan 2. Form CAPA
Does the factory take corrective actions based on results from previous inspections, non-conforming materials in production, and client feedback? Check Point : 1. CAPA 2. Monitoring CAPA
Does the factory execute a corrective action process with investigation and resolution for nonconforming products? Check Point : 1. CAPA 2. Monitoring CAPA
Does the factory conduct critical safety testing for all product categories? Check Point : 1. Test BV 2. Test Internal GCP 3. MCP
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? Check Point : 1. MCP 2. Checklist Kelembaban 3. AK INC & OG
Does the factory conduct final inspections? Check Point : 1. Final Inspection
Are there documents or records to support final inspections are conducted? Check Point : 1. Full Lot Inspection
Is there management commitment, oversight, and actions taken to evaluate the quality system using quality goals and key performance indicators? Check Point : 1. Sasaran Mutu/KPI 2. Management Review
Did the 20 Piece workmanship audit pass? Check Point : 1. Internal Audit untuk pengecheckan proses sesuai requirement Target 2. PQC

Site Conditions

Is the facility clean and organized? Check Point : 1. 5R/5S
Does the facility have sufficient lighting? Check Point : 1. Penerangan Area (Lux Meter)
Is the facility well ventilated? Check Point : 1. 5R/5S
Are building/facility conditions properly maintained to prevent mildew/mold growth? Check Point : 1. Prosedur pengendalian jamur 2. Stadarisasi Pallet 3. Standarisasi peletakan Raw Material & FG 4. Checklist Humidity
Are raw materials and finished goods appropriately stored to avoid damage and deterioration? Check Point : 1. FIFO System 2. FG tidak boleh diletakkan di luar ruangan 3. FG disimpan di lantai, jauh dari dinding pada palet atau rak dan ditutup untuk mencegah debu / kotoran terpapar (jika perlu). 4. FG harus kering dan tidak boleh basah atau rusak.
Are client-branded packaging materials and labels secured and in good condition? Check Point : 1. In-store area 2. Logbook 3. Monitoring stock

Process Control

Is there a process that defines how documentation and records are controlled, including current version, accessibility, and proper disposal? Check Point : 1. PS.01 - Pengendalian Dokumen 2. PVP
Does the factory properly store, protect, update, and dispose of quality documentation and records? Check Point : 1. PS.01 - Pengendalian Dokumen 2. PVP 3. Final-Iso
Are ongoing Quality Control (QC) meetings held at the factory in which Production is represented and quality topics discussed? Check Point : 1. Quality Meeting
Does the QA (Quality Assurance) or QC (Quality Control) department operate separately from the Production Department? Check Point : 1. SO All Department 2. SO Quality
Is there a documented process to show that clients are notified immediately on issues of product safety or regulatory non-compliance? Check Point : 1. PS.20 - Penanganan Keadaan Tidak Terduga 2. AK/QMR/01- Penanganan Keadaan Tidak Terduga

INTERNAL AUDIT - QAFA

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Manufacturing Control Plan

Product Development

Supplier Management

Production Control

Equipment & Maintenance

Training

Quality Management System

Site Conditions

Process Control

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INTERNAL AUDIT - QAFA

Free INTERNAL AUDIT - QAFA Checklist

Go digital today!

Convert your paper checklists into digital forms

Manufacturing Control Plan

Product Development

Supplier Management

Production Control

Equipment & Maintenance

Training

Quality Management System

Site Conditions

Process Control

Related checklists