Quality Program Management
Are persons responsible for performing Quality Assurance functions named, qualified and trained to carry out defined duties?
Yes
No
N/A
Quality System
Is the Quality System registered to an ISO Standard?
Yes
No
N/A
Is there a record retention system for maintaining certifications, test reports and other pertinent quality related documentation?
Yes
No
N/A
Is there an employee training program?
Yes
No
N/A
Is there a procedure to control and segregate of nonconforming products?
Yes
No
N/A
Is there an established receiving inspection / verification process?
Yes
No
N/A
Does the established system have provisions for items that may require specific environmental conditions (i.e, temperature and humidity)
Yes
No
N/A
Is the quality system reviewed periodically to assess its continued suitability and effectiveness?
Yes
No
N/A
Contract Review
Are all new contracts and purchase orders reviewed for adequacy prior to acceptance?
Yes
No
N/A
Document Data Control
Does the supplier maintain standard procedures for the control of documents, specifications and data pertinent to the product?
Yes
No
N/A
Is the technical data, specific to the products available, current, legible and accessible?
Yes
No
N/A
Is there a documented procedure for the method of storage, distribution and retrieval of documents that confirm the products conformance to the applicable specifications?
Yes
No
N/A
Do records indicate a clear path of traceability?
Yes
No
N/A
Purchasing
Is there a procedure that will assure that all procured items meet the PO and Customer requirements?
Yes
No
N/A
Does the supplier have a list of approved suppliers and/or manufacturers supplemented by data regarding product quality?
Yes
No
N/A
Product Identification and Traceability
Does your program control the identification of product from receipt to delivery?
Yes
No
N/A
Does your facility co-mingle or split batches of material to meet the needs of the customer?
Yes
No
N/A
Do you maintain traceability to the original batches of material?
Yes
No
N/A
Incoming Inspections and Testing
Does your Quality System document the criteria for product acceptance as for each product that is received into inventory?
Yes
No
N/A
Are the documents that are received with product checked by inspection personnel for authenticity and completeness of data against the product that is received?
Yes
No
N/A
Are the purchase order requirements and lot / batch references verified against the product that is received?
Yes
No
N/A
Outgoing Testing and Inspections
Does your outgoing inspection verify the product certification and that the product is in accordance with the purchase order requirements?
Yes
No
N/A
Is the order checked for application of any pertinent documentation such as Certificate of Conformance as specified by the purchase order?
Yes
No
N/A
Control of Inspection, Measuring and Test Equipment
Does your facility document and maintain procedures to control, and calibrate measuring and test equipment, to include any test software and personally owned equipment used to accept products?
Yes
No
N/A
Are all calibrated tools traceable to a recognized national or international standard?
Yes
No
N/A
Is each piece of measuring and test equipment identified with the status and date of calibration?
Yes
No
N/A
Does your facility have a procedure for the recall of product after shipment if a tool used to inspect it prior to shipment is found to be significantly out-of-tolerance?
Yes
No
N/A
What is your retention period for records that pertain to calibrated tools?
How often are your tools calibrated?
Inspection and Test Status
Does the method used to identify the inspection and test status of a product indicate the conformance of the product with regard to verifications, inspections or tests performed?
Yes
No
N/A
Is the system used for identification and test status a documented procedure?
Yes
No
N/A
Is the identification of the inspection or test status maintained throughout all cycles of product handling?
Yes
No
N/A
Do you maintain records that identify the personnel authorized to verify, certify and release products?
Yes
No
N/A
Do you have a documented procedure for the control of all methods of acceptance media such as stamps signatures or passwords?
Yes
No
N/A
Control of Nonconforming Products
Does your facility maintain procedures pertaining to the identifcation, documentation, evaluation, segregation, disposition and customer notifcation with regards to nonconforming products?
Yes
No
N/A
Are items that are dispositioned as "scrap" permanently marked as such, or rendered useless?
Yes
No
N/A
Does your facility maintain a procedure for identifying the root cause of a discrepancy?
Yes
No
N/A
Is there a procedure for implementing an effective corrective action?
Yes
No
N/A
Handling, Storage, Packing, Preservation and Delivery
Is your facility audited periodically by your own personnel to verify the adequacy of storage, environmental controls and identification methods?
Yes
No
N/A
Does your facility properly segregate each lot and batch of material?
Yes
No
N/A
Are life limited materials identified?
Yes
No
N/A
Can your current program assure that an adequate shelf life remains on the part before it is shipped to the customer?
Yes
No
N/A
Control of Quality Records
Are records pertaining to product quality, integrity and traceability adequately protected from damage, deterioration, alteration and unauthorized access or loss?
Yes
No
N/A
Does your facility maintain a record retention policy?
Yes
No
N/A
How long is the record retention period?
