1. Are written quality program plan(s), manual, procedures and instructions available, adequate and effectively implemented. (Ref. para 4.2.1, 4.2.2)

• Does the supplier have an effective system to control required documents to include, approval, review, updates, identification, legibility, distribution, as well preventing unintended use of obsolete documents? (Ref. para 4.2.3, 7.3.7, 7.5.1b)

• Are quality records maintained that demonstrates effective operation of the supplier's quality system? (Ref. para 4.2.4)

• Is there, a; Analysis of internal quality system feedback by quality assurance management, b; Prompt corrective action, and c; Improvement action to adjust the quality control system itself? (Ref. para 4.2.4, 5.6.1, 8.5.1)

C.

• Is the quality function fully supported by top management. (Ref. para 5.1, 5.3, 5.4)

• Does top management ensure customer requirements are addressed and met? (Ref. para 5.2, 7.2.1, 8.2.1)

• Does the company have a quality policy? (Ref. para 5.3)

• Has top management ensured quality objectives and a quality plan have been established that are understood are relevant functions in the organization? Do they support the quality policy? (Ref. para 5.4.1, 5.4.2)

• Are key personnel clear about their responsibility and authority in supporting the quality plan? (Ref. para 5.5.1)

• Is there a top management representative? If so identify him/her. (Ref. para 5.5.2)

• Does supplier: a. Maintain procedures for recording inspection and test results, clearly identifying defects and defective conditions found, and b. Report results to quality assurance management? (Ref. para 5.6.1, 7.5.3, 8.2.4, 8.4b &c, 8.5.1)

• Do management reviews of the quality system take place at regular intervals and do these reviews contain adequate inputs to effectively evaluate the performance of the quality system. (Ref. para 5.6.1, 5.6.2)

• When necessary, does management review of the quality system result in actions to make changes to improve the system? (Ref. para 5.6.3)

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• Does supplier: a. have sufficient capability to achieve customer satisfaction, including equipment, processes and qualified human resources? (Ref. para 6.1, 6.2.1, 6.2.2))

• Does supplier follow an adequate schedule for periodic evaluation and training of inspection and test personnel? (Ref. para 6.2.2b)

• Are post training reviews performed to evaluate the effectiveness of training? (Ref. para 6.2.2c)

• Are environmental conditions suitable, to include adequate lighting and good housekeeping, to support accurate inspections and tests? (Ref. para 6.3)

• Is sufficient infrastructure provided and maintained to ensure product conforms to requirements? (Are the right measures taken in storage, equipment, utilities and environment to produce and protect the product?) (Ref. para 6.3, 6.4)

• Does the supplier plan for product realization that is consistent with other processes? (Ref. para 7.1)

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• Does the supplier determine requirements related to the products? (Ref. para 7.2.1)

• Is this capability and customer requirements reviewed prior to making contract commitments? (Ref. para 7.2.2)

• Does the supplier review the requirements related to the products? (Ref, para 7.2.2)

• Does supplier have a customer feedback program? Are customers concerns addressed, and presented to top management with a summary of actions taken? (Ref. para 7.2.3)

• Does the supplier do design and development planning? (Ref. para 7.3.1)

• What are the design and development inputs? (Ref. para 7.3.2)

• What are the design and development outputs? (Ref, para 7.3.3)

• Does supplier have documented procedures to control and review design and development of the product in order to ensure that the specified requirements are met? Are records of these reviews maintained. (Ref. para 7.3.4, 7.3.5)

• Does supplier conduct design and development validation? (Ref. para 7.3.6)

• Does supplier use effective procedures to evaluate and select subcontractors, and to assure they continually provide only acceptable product, including a contractor evaluation system? (Ref. para 7.4.1)

• Does the supplier ensure the adequacy of the specified purchase requirements prior to communication to their suppliers? (Ref. para 7.4.2)

• Does supplier inspect, test and assure the quality of incoming components and raw materials where critical to the final product? (Ref. para 7.4.3, 8.1a)

• Is the production carried out under controlled conditions? Ref. para 7.5.1

• Does supplier validate the production processes? (Ref. para 7.5.2)

• Does the supplier use product identification for traceability where appropriate? (Ref. para 7.5.3)

• Is customer supplied product identified and controlled in a manner to prevent pilferage of intellectual property right and/or damage? (Ref. para 7.5.4)

• Are there adequate controls in the handling, storage and packaging of the product to assure its protection to the final customer, including mail order items? (Ref. para 7.5.5)

• Is inspection and test equipment adequately maintained, calibrated and secured? Are calibration records maintained and equipment identified with calibration status? (Ref. para 7.6, 8.1a)

• Does supplier employ his own or an outside laboratory, or a combination, to conduct tests? (Specify details, including qualifications of lab(s) for tests performed? (Ref. para 7.6, 8.1a, 8.2.4)

• Does supplier measure customer satisfaction and customer return data? (Ref. para 8.2.1, 8.4d)

• Does the supplier have an internal audit plan? Are internal audits by the supplier timely and effective? (Ref. para 8.2.2, 8.2.3)

• Does supplier maintain and effectively control work in process by use of inspection points at critical stages of the production process? (Identify and describe all inspection points, including characteristics evaluated, quality levels, effectiveness and any shortcomings). (Ref. para 8.2.3, 8.2.4)

• Does supplier maintain an effective end-item quality audit with a reliable inspection sampling plan(s) for evaluating quality acceptability of outgoing products, documenting the outgoing quality levels and evaluating the adequacy of in-process controls? (Ref. para 8.2.4)

• Does supplier maintain adequate identification, segregation, disposition and control of non-conforming products/inspection lots? Is the procedure documented and records maintained? (Ref. para 8.3)

• What data analysis is performed to demonstrate the suitability and effectiveness of the quality system, continual improvement and customer satisfaction? (Ref. para 8.4)

• How is the quality system continually improved? (Ref. para 8.5.1,8.1c)

• Does Quality assurance notify the appropriate personnel on a timely basis when corrective actions are necessary and is the notification process documented? (Ref. para 8.5.2, 8.5.3)

• Is timely and effective corrective action and preventive action taken by operations management (e.g., procurement or production) to eliminate and prevent causes of defective conditions? (Ref. para 8.5.2, 8.5.3)

• Does supplier quality assurance follow-up to ensure corrective actions are effective and that adequate preventive actions were implemented? (Ref. para 8.5.2, 8.5.3)