Title Page
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Site conducted
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Conducted on
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Prepared by
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Auditee
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Department
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Process
Audit Checklist
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Have all responsibilities, methods, measurements and related performance indicators, needed to ensure the effective operation and control, been established?
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Have responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization
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Has the department Determine the goals and objectives to each department?
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Has the department defined a plan or strategy to achieve the Goals and Objectives?
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Are Quality Objectives monitored and reviewed at reasonable intervals?
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Has The department identify the causes of not achieving their Objectives, Monthly/ quarter or annually objectives
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Has the organization identified risks and opportunities for each process (use riskbased )
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Have the risk assessment been communicated to the employees and signed
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Does the process risk assessment take the following into account? 1Manufacturing parameters such as pressure, time, temperature. 2 Conditions of equipment, molds, dies, machinery 3Chemicals / materials used for equipment (e.g. lubricating oils and paints) 4 Calibration of equipment. 5 Policies on microbiological contamination (e.g. hygiene of toilet & canteen, pest control) 6 Personal protective equipment (including specific clothing and footwear)
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Is the risk assessment regularly reviewed, at twice per annually or when changes made to product design and materials and/or key manufacturing processes?
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Has the company improve the awareness of the employees from time to time
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Has the department fully complied with the QMS document control
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Have all actions taken to close the NCR by Internal / External audit effectively closed
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How the department Handle customers returns /action taken on this return
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Method of Communications between the Sales & the dispatch department
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Has the department identify their products release to the customer
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how the department Handle the delay in the delivery of the finished product & action taken?
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How the company handle the scrap products
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Does it include incoming/WIP/finished goods inventory check? Are the results accurate enough?
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Does the department work on a FIFO system?
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Are safety/consignment stocks levels monitored?
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Are packaging and shipping instructions clearly posted at point of operations, and are they known by operators?
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Are finished goods properly identified according to Internal Procedure requirements?
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Has the warehouse arranged and identified by products category
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How the Process of Dispatch performed started from receiving the order to deliver to next step?