Title Page
-
Client / Site
-
Location
-
Conducted on
-
Prepared by
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
