You can use this comprehensive audit checklist to warrant that the supplier’s quality management system (QMS) meets business demands and standards. Suppliers can use this template to document and report any non-compliance to quality norms. It has 99 parts and been built to help the inspector to conduct a site walkthrough in the warehouse or production. Use this template as a guide to handle any risk identified. Allocate actions to teams in charge concerning critical issues that may appear during the inspection. End the inspection with a digital signature and timestamp to verify the audit.
Are quality-performance objectives clearly established, included in the business plan and controlled for developments?
Is the quality system reported, controlled and advanced to precisely describe current practice?
Do quality reports, trend charts and data analysis distinguish areas of opportunity and are used by management regularly?
Does executive management engage in periodic quality system reports addressing quality-connected feedback from clients and internal quality metrics?
Continuous Improvement
Are defensive actions taken based on the analysis of meaningful business trends, design studies, customer gratification surveys or other essential inputs?
Is there a written approach utilised to actively track cost containment and other continuous development activities throughout the company?
Is there a corrective action system that implements root cause analysis and takes timely and adequate action to stop recurrence?
Does the corrective action system cover consumer, internal and supplier issues?
Education & Training
Is the profession and education level that is needed for each job documented and is appropriate training implemented?
Is employee skill/certification sustained where the quality outcome of the method cannot be supported and is strongly dependent upon operator ability?
Are suitable processes used to verify training effectiveness?
Occupational Health & Safety
Does the health and safety management system discuss the safety of employees without involving the achievement of product quality demands?
Does the health and safety policy state the company’s health and safety goals and management's dedication to the continual development of H&S metrics?
Does the health and safety management system approach the demand for emergency planning?
Are methods used for the on-going identification of dangers, the assessment of risks, and the implementation of required control measures?
Design & Development Support
Are human and technological resources are sufficient to meet the demands for design collaboration, tooling design, and electronic illustration and data exchange?
Are Critical-to-Quality (CTQ) features identified, registered and records retained?
Are product specifications and drawings generated, regulated and sustained for new or changed product designs?
Is design confirmation an integral component of the design process and occurs previous to product release?
Are customer requirements included in product designs and/or production processes?
Quality Planning
Is product fidelity test data is accessible upon request and historical test performance data reveals a highly stable process and product plan?
Are customer production demands and quality specifications reviewed to guarantee they can be met on a regular basis?
Are reliability test plans established and routinely followed?
Is testing used to support the design specifications, drive design developments and present an on-going check of materials and workmanship?
Are production examples examined and granted to customers upon request?
Customer Documentation
Does customer advice/approval lead to changes to control plans, production site, product transfers, raw material or product obsolescence?
Are new and improved customer specifications reviewed and performed in a timely manner?
Are current process control documents in place and worked with for production start-up and proceeding production?
Are quality records maintained?
Is there a record control scheme for the protection, identification, storage, retrieval, retention time, and disposition of quality records?
Procurement
Are preventive actions used to continuously develop the performance of the supplier base?
Are buying from unapproved suppliers limited by a properly managed and available approved supplier list?
Is there a formal method used for the selection, modification and re-qualification of suppliers?
Does the supplier assurance system guarantee that all purchased product or material conforms to established specifications and applicable regulatory or customer demands?
Is there a system for the identification, verification and protection of customer provided product that includes informing the customer if the product is destroyed or lost?
Incoming Material
Is examined material adequately identified as to acceptance or dismissal and traceable to getting inspection report?
Is receiving inventory performed per documented systems and detailed work instructions?
Do suppliers improve action questions requiring root cause study show responses are investigated?
Manufacturing Quality
Is there a confirmed plan used to qualify new or rebuilt production tools prior to production use?
Is the investigation and process status of the product identified and sustained throughout the manufacturing process?
Are control plans used to organise and deploy inspection and test functions during the production process?
Are proper inspections, tests and process adjustments made per applicable work guidance to establish conformance at key points throughout the method and prior to shipment?
Are relevant work instructions available where required that accurately describe all work processes including inspections and tests to be done throughout the production?
Are customers informed of low yield production lots or issues that affect product reliability?
Process Control
Are key part features and process parameters examined and statistically based checks and/or problem-solving tools are used to control variation?
Is process capability regulated and are actions taken to sustain established minimum Cpk/Ppk targets?
Are out of control circumstances noted on charts and reported corrective action taken to bring the method back into control?
Are written development plans implemented to decrease sources of variation?
Nonconforming Material
Are nonconforming supplies, parts and assemblies isolated (where practical) and recognised to prevent unapproved use?
Are control plans utilised to plan and use inspection and test functions during the production process?
Are appropriate inspections, tests and process arrangements made per applicable work instructions to support conformance at key points during the process and previous to shipment?
Is the inspection and process status of the product recognised and sustained throughout the production process?
Are appropriate work directions available (where demanded) that correctly describe all work methods including examinations and tests to be done during creation?
Are customers informed of low yield production lots or issues that influence product reliability?
Are key part components and process parameters evaluated and statistically based controls and/or problem-solving tools are used to control variation?
Are written development plans implemented to decrease sources of variation?
Are out of control conditions are noted on charts and documented corrective action is taken to bring the process back into control?
Is process capacity measured and are actions taken to support established minimum Cpk/Ppk targets?
Are nonconforming supplies, parts and assemblies separated (where practical) and identified to limit unapproved use?
Is the use of nonconforming material reported and written down below a formal waiver or concession system?
Is there a positive recall system to report customers of nonconforming assets that have already been transmitted?
Are reworked material, components and assemblies re-inspected or re-examined to confirm compliance to demands?
Is product traceability maintained to facilitate problem assessment and improving action?
Monitoring & Measurement
Are evaluations made to check the validity of previous measurements done on goods where out-of-calibration measuring tools were used?
Are measuring tools and test equipment regularly calibrated and controlled per documented methods?
Are there relevant controls to verify the appropriateness and accuracy of computer software previous to initial use in checking output quality or control of processes?
Are standards and test equipment calibrated against standards visible to a recognized regulatory body or agency?
Are measure repeatability and reproducibility studies conducted to check the suitability of measuring things for their use in controlling product quality or control of methods?
Maintenance
Is equipment stored in a proper, clearly established area, with systematic tracking that gives traceability, particularly of customer-owned tools and equipment?
Does a well-defined preventive maintenance system (PM) exist for production equipment?
Is the preventive maintenance schedule is followed since the outcome cannot be made with tools that are outside of the maintenance period?
Environment
Is there a program in place to decrease the use, disposal and emissions of dangerous chemicals not used in the production process?
Is there an environmental management system that assures compliance to all applicable government laws and there are no unusual, unresolved violations of these arrangements?
Does a documented environmental policy exist that involves a commitment to comply with important environmental legislation and regulations and to constant improvement and pollution interception?
Is there an on-going emphasis placed on using supplies that are compliant with relevant regulations like biodegradable, recyclable, reusable, decreases pollutant emissions at the point of use?
Storage & Packing
Are areas around the buildings clean and orderly? Is equipment properly stored and readily accessible for use? Is lighting and air quality sufficient?
Is fitting equipment and methods used to limit product damage or damage in all phases of the material handling process?
Are documented procedures followed to assure control and preservation of handling, storage (FIFO), packaging, and shipment of the product?
Is the appropriateness of product packaging evaluated and concerns communicated to the customer previous to initial production delivery?
Is stocked product/material periodically inspected, and are actions taken to prevent deterioration per documented systems, if necessary?
Have contingency plans been established that describe actions to be taken in the case of a major delay of the production process?
Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.
