Title Page
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Site conducted
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Vendors Name
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Fly Name
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Address
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Evaluation Start Date and Time
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First MAST evaluation
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List previous REF #
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Number of Employee
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No.of Machines
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Last Evaluation Date
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Name of Contact Person
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Title of Contact Person
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Rating
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Phone
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Fax
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Email
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Evaluator
INCOMING MATERIALS CONTROL
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1. Are there written procedures for the receipt, identification, storage, handling, sampling, testing and approval of raw materials, component parts, sub-components and package?properly implemented?
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2. Are raw materials, component parts, sub-components and package withheld fromproduction until released by QA/QC?
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3. Is status of raw materials/component parts/package identified with a status label and or are they held in corresponding quarantine areas? And were they kept off floor?
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4. Is there a representative sized sample taken from raw materials, component partssub-components and package inspected at receipt (within 72hours)? And any report?
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5. Is there incoming insepction standard including sample, product spec. and defective category list?
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6. Are incoming material samples labeled with lot number, the date and the person who collected the sample? Are they resealed in a manner & in an area to prevent contamination?
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7. Do COAs/COCs exist for raw material, conponent parts,sub-components and package ?
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8. Are representative samples of each lot of raw material pulled and tested/examined for physical and/or chemical characteristics as specified? Testing report ?
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9. Is there a quarantine system for rejected/expired raw materials, component parts, sub-components and package designed to prevent their use? And follow up and records?
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10. Is there MRB (material review board) practice on raw materials, component parts, sub-components and package? If yes, any nofication to clients and proper follow up on MRB material?
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11. Chemicals/high risk components are properly marked and stored in proper area to prevent risk of contamination?
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12. Is FIFO used for raw materials, component parts, sub-components and package? Any record and identification on bulk?
SUPPLIER MANAGEMENT
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1. Are there written procedures for control to suppliers of raw materials, component parts, sub-components
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and package including selection and approval process, tracking and evaluation reliability/performance?
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2. Does factroy keep qualified supplier list? Did all incoming material come from the qualified suppliers?
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Any exceptional?
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3. Does factory monitor and evaluate suppliers quality performance and reliability? Any record?
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4. Does factory onsite audit the suppliers periodictly?'Does QC team join? What's frequency? any record?
PROCESS AND PRODUCTION CONTROL
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1. Are there written procedures for process and manufacturing control?
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2. Does factory conduct pre-production meeting for key project prior to startup of production? Are critical quality and safety checks reviewed, identified, and actions for improvement documented during Pre-production meeting ?
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3. Does factory conduct “pilot-run” to validate through PP meeting action points,also review product quality against specification sheet and document results with corrective actions prior to production?
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4. Are all production processes performed within specifically defined areas to prevent contamination or mix-ups?
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5. Does all production processes setup make sense, without unnecessary back-forth transferring to avoid damage, contaimination or mix-ups? Are different lines with consistent setup/jigs for same item production?
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6. Does factory have the resonable flow chart at key process and follow it? Does production lines ran smoothly without piling up?
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7. Does factory IPQC or QC leader compare first article samples with approval sample and specification sheet? And any record?
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8. Are there adequate approved samples, first article samples and work instructions provided to workers? Do workers follow work instructions to operate and were monitored?
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9. In-line inspections are performed by QC at every operation process (IPQC) ? what's roving check frequency? Is there batch release practice for key processes ?And records?
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10. Does factory perform full check/test by specific person who cannot clean on final products before packing?
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11. Are there written proceduce of non-conformance control during manufactoring?any procedure/red box implemented? Does IPQC and IPQC leader has authority to stop production if serious quality issue ocurred? If yes, any CAP record and follow up?
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12. Is line clearance between batches documented?
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13. Is all major equipment identified and documented in the production record? Traceability record?
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14. Are representative samples of semi-products or finished goods pulled and tested/examined for function/physical characteristics as specified? And testing report ?
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15. Are semi-products and finished goods inspected to ensure compliance to specifications, batch releasing? And report? For one item produced by different lines, any periodical comparsion?
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16. Are tempo. storage of semi-products, finished goods and defects clearly marked and quanranteed very well?
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17. Are there good housekeeping in all areas of production sections?
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18. Are standards of finished product stored in proper manner that prevents accelerated aging and contamination and retained for three years?
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19. Does factory implement strict cutting devices control procedure to prevent scissors,knives,blades and needles to be mixed with production?Any delegated person to manage the sharp tool control system?
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20. Is there a change control process and are all changes to package component specifications properly documented? Any case?
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21. Are all production related instructions/records and quality reports retained well? Are production records/quality reports retained for 4 years (either hardcopy or softcopy)?Are records retrievable within 24 hours?
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22. Do the personnel use protective apparel such as head, face and arm coverings properly to protect human being and to prevent product contamination?
HOLDING AND DISTRIBUTION
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1. Are there written warehousing procedures for withholding all in-processes and finished goods until approved by QA/QC?
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2. Are all in-process and finished goods tagged with correct identification card?
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3. Is there a quarantine area for rejected in-process parts and finished product?
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4. Are there written procedures for disposal of rejected in-process parts and finished product in a manner that assures it is not used?
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5. Is there a SOP on finished product release to assure compliance to client's requirements - specification compliance, standard samples and documents?
QUALITY ASSURANCE/QUALITY CONTROL
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1. Is there a QA/QC unit independent out of Production division? Are factory and QC team orgnization chart available?
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2. Has factory existed quality policy and objective that is appropriate to their products and procedures? are Workers & Supervisors familiar to these quality policies and objectives. Any slogan presented?
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3. Does the QA/QC unit have written procedures to approve or reject raw materials, component parts, sub-components, package, in-process materials, and finished products?
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4. Are adequate in-house laboratory facilities available to the QA/QC unit for testing and approval or rejection of raw materials, component parts, sub-components,package, in-process materials and finished product? Any working instruction?
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5. Does the QA/QC unit approve all procedures and specifications that impacting the identity and quality of the product?
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6. Does factory have separate inspection area with inspection table and proper envirement for quality control activities (IQC/IPQC/FQC/OQC)?
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7. Are finished goods inspected properly by QA/QC prior to release for shipping?
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8. Are QC members qualified? Do they have good quality awareness and sensitivity? Do they have enough knowledge about product and be familiar with quanlity standards?
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9. Do production management and QC team have a peroidical meeting to review and discuss - defect statistics shared ? Does QC team have an internal periodical meeting to share quality issues? and any record?
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10. Product standards and guidelines are readily available and in use by the inspectors?
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11. Is all testing completed before the shipping release was signed?
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12. Is there an appropriate CAPA system in place to identify and resolve quality based issues? Any case?
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13. Are there written procedures for calibration of equipments and instruments?
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14. Is there an instrument and equiments list? Does factory have a calibration plan and record? Does internal calibration operator have certificate?
BUILDING AND FACILITIES
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1. The outside of the building is maintained free of trash and debris that provide harborage.
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2. The building size and construction facilitate cleaning maintenance and operations.
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3. Is there adequate space to prevent mix-ups of raw materials, component parts sub-components, package, in-process materials and finished products and to prevent contamination?
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4. Are measures in place of production workshops to prevent contamination (eg.window closed or screened)?
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5. Is there adequate lighting,especially in QC areas?
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6. Is there adequate filtered ventilation to production operations especially where finished product is exposed?
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7. Are there adequate drains for equipment and to prevent standing water?
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8. Are there proper machines in factory to produce the product Mast Global intends to buy? Machine list?
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9. Is there a maintenance function to maintain production equipment? Is it provided by certified personnel ? Can it provide immediate response to machinery problems that affect production?
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10. Are machines / equipment periodically maintained, and checked to ensure efficient operation? Is there a documented preventative maintenance schedule? And record?
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11. Are there written procedures or sub-contract agreement for pest control including a drawing or floor plan showing the placement of control devices?
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12. Are there power generator(s)? Ready to support if any power source shortage?
TRAINING
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1. Is there a on-boarding training including particular operations and quality awareness for new employees and any record?
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2 Is there an annual training plan in GMP/ISO:9001 concept/practice?
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3. Any record of training properly retained?
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4. Is the training conducted by a qualified individual?
LOSS PREVENTION
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1. Are there adequate controls to prevent the loss of finished goods and/or component from the facility? components with logo were managed by delegated person, storage with limited access?
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2. Are visitors requested to register? Any visitor badge presence required during plant tour? Is facility access controlled and monitored after hours? Are the access records reviewed periodically by management?
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3. Are procedures in place for the proper notification and destruction of unacceptable/obsolete finished goods and/or package components? Any record?
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4. Are products shipped in a controlled & secured manner to prevent tampering, contamination or loss during transit?
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5. Is there any CT-PAT practice (certificate)?
SIGN OFF
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Report Prepared By (Name and Signature)
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Report Approved By (Name and Signature)
