Audit

Quality Management

Is the quality system documented, controlled and maintained to clearly describe current practice?

Do quality reports, trend charts and data analysis identify areas of opportunity and are used by management on a routine

Are quality-performance targets clearly defined, included in the business plan and monitored for improvements?

Does executive management participate in periodic quality system reviews that address quality-related feedback from customers and internal quality metrics?

Continuous Improvement

Are preventive actions taken based on the analysis of significant business trends, design reviews, customer satisfaction surveys or other meaningful inputs?

Is there a formal approach used to actively pursue cost containment and other continual improvement activities throughout the organization?

Is a corrective action system in place that provides root cause analysis and takes timely and effective action to prevent recurrence?

Does the corrective action system cover customer, internal and supplier issues?

Education & Training

Is the skill and education level required for each job documented and appropriate training provided?

Is employee qualification/certification maintained where the quality outcome of the process cannot be verified and is strongly dependent upon operator skill?

Are suitable methods used to verify training effectiveness?

Are suitable records of maintained?

Occupational Health & Safety

Does the health and safety management system address the safety of personnel without comprising the achievement of product quality requirements?

Does the health and safety management system address the requirement for emergency planning?

Does the health and safety policy state the organization’s health and safety objectives and management's commitment to continual improvement of H&S metrics?

Are procedures used for the on-going identification of hazards, the assessment of risks, and the implementation of necessary control measures?

Design & Development Support

Are customer needs and requirements incorporated into product designs and/or manufacturing processes?

Are Critical-to-Quality (CTQ) characteristics are identified, understood and records retained?

Are product specifications and drawings generated, controlled and maintained for new or changed product designs?

Is design validation is an integral part of the design process and occurs prior to production release?

Are human and technical resources are adequate to meet the requirements for design collaboration, tooling design, and electronic drawing and data exchange?

Quality Planning

Are production samples inspected and provided to customers upon request?

Are customer production requirements and quality specifications are reviewed to ensure they can be met on a consistent basis?

Are reliability test plans developed and routinely followed?

Is testing used to verify the design specifications, drive design improvements and provide an on-going check of materials and workmanship?

Is product reliability test data is available upon request and historical test performance data shows a highly stable process and product design?

Customer Documentation

Are new and revised customer specifications reviewed and implemented in a timely manner?

Are current process control documents in place and used for production start-up and continuing production?

Does customer notification/approval occur for changes to control plans, manufacturing site, product transfers, raw material or product obsolescence?

Is there a record control system is in place for the identification, storage, protection, retrieval, retention time, and disposition of quality records?

Are quality records maintained?

Procurement

Is there a formal process used for the selection, qualification and re-qualification of suppliers?

Are purchases from unapproved suppliers prevented by a properly controlled and available approved supplier list?

Are purchases from unapproved suppliers prevented by a properly controlled and available approved supplier list?

Are preventive actions taken to continuously improve performance of the supplier base?

Does the supplier assurance system ensure that all purchased product or material conforms to defined specifications and applicable regulatory or customer requirements?

Does a system exist for the identification, verification and protection of customer supplied product that includes notifying the customer if product is damaged or lost?

Incoming Material

Is receiving inspection performed per documented procedures and detailed work instructions?

Is inspected material adequately identified as to acceptance or rejection and traceable to receiving inspection report?

Do supplier corrective action requests requiring root cause investigation show responses are analyzed?

Manufacturing Quality

Is there a formal method used to qualify new or rebuilt production equipment prior to production use?

Are control plans used to plan and deploy inspection and test functions throughout the production process?

Are appropriate work instructions are available where needed that accurately describe all work methods including inspections and tests to be done during production?

Are appropriate inspections, tests and process adjustments made per applicable work instructions to verify conformance at key points throughout the process and prior to shipment?

Is the inspection and process status of the product identified and maintained throughout the production process?

Are customers notified of low yield production lots or issues that affect product reliability?

Process Control

Are key part characteristics and process parameters are reviewed and statistically based controls and/or problem solving tools are used to control variation?

Are written improvement plans are implemented to reduce sources of variation?

Is process capability is measured and actions are taken to maintain established minimum Cpk/Ppk targets?

Are out of control conditions are noted on charts and documented corrective action is taken to bring the process back into control?

Nonconforming Material

Are nonconforming materials, parts and assemblies are segregated (where practical) and identified to prevent unapproved use?

Are control plans used to plan and deploy inspection and test functions throughout the production process?

Are appropriate work instructions are available where needed that accurately describe all work methods including inspections and tests to be done during production?

Are appropriate inspections, tests and process adjustments made per applicable work instructions to verify conformance at key points throughout the process and prior to shipment?

Is the inspection and process status of the product identified and maintained throughout the production process?

Are customers notified of low yield production lots or issues that affect product reliability?

Are key part characteristics and process parameters are reviewed and statistically based controls and/or problem solving tools are used to control variation?

Are written improvement plans are implemented to reduce sources of variation?

Is process capability is measured and actions are taken to maintain established minimum Cpk/Ppk targets?

Are out of control conditions are noted on charts and documented corrective action is taken to bring the process back into control?

Are nonconforming materials, parts and assemblies are segregated (where practical) and identified to prevent unapproved use?

Is reworked material, parts and assemblies are re-inspected or re-tested to confirm compliance to requirements?

Is the use of nonconforming material is documented under a formal waiver or concession system?

Is product traceability maintained to facilitate problem evaluation and corrective action?

Is there a positive recall system to notify customers of nonconforming product that has already been shipped?

Monitoring & Measurement

Are gauge repeatability and reproducibility studies conducted to verify suitability of measuring devices for their use in checking product quality or control of processes?

Are measuring devices and gauges and test equipment are routinely calibrated and controlled per documented procedures?

Are gauges and test equipment calibrated against standards traceable to a recognized regulatory body or agency?

Are assessments made to check the validity of previous measurements done on products where out-of-calibration measuring devices were used?

Are appropriate controls are in place to verify the suitability and accuracy of computer software prior to initial use in checking product quality or control of processes?

Maintenance

Are tools stored in an appropriate, clearly defined area, with systematic tracking that provides traceability, particularly of customer-owned tools and equipment?

Does a formal preventive maintenance system (PM) exist for production equipment, tools and fixtures?

Is the preventive maintenance schedule is followed since product cannot be made with tools that are outside of maintenance period?

Environment

Does a documented environmental policy exist that includes a commitment to comply with relevant environmental legislation and regulations and to continual improvement and pollution prevention?

Is there is an environmental management system that ensures compliance to all applicable government regulations and there are no outstanding, unresolved violations of these regulations?

Is there a system is in place to minimize the use, disposal and emissions of hazardous chemicals are not used in the manufacturing process?

Is there an on-going emphasis is placed on using materials that are; compliant with applicable regulations like WEEE, biodegradable, recyclable, re-usable, reduces pollutant emissions at the point of use?

Storage & Packing

Are areas around the facility clean and orderly and are tools and equipment properly stored and readily available for use and is lighting and air quality are adequate?

Is proper equipment and methods used to prevent product damage or loss in all phases of the material handling process?

Are documented procedures followed to ensure proper control and preservation of handling, storage (FIFO), packaging, and delivery of product?

Is the suitability of product packaging reviewed and concerns communicated to the customer prior to initial production shipment?

Is stored product/material periodically inspected, and where applicable, actions are taken to prevent deterioration per documented procedures?

Have contingency plans been developed that describe actions to be taken in the event of a major interruption of the manufacturing process?

Completion
Full Name and Signature of Inspector