Does your company have work 5: Work 3: Informal process 1: No Work instructions that are used to control Instructions exists Instructions 10 manufacturing (or service) processes, established established inspection operations and product/equipment release testing? Does your company have an 5: Policy/ 3: Informal system 1: No Policy/ Inspection and Testing Procedure exists Procedure 11 Policy/Procedure? established established Does your company have a Training 5: Policy/ 3: Informal system 1: No Policy/ 12 Policy/ Procedure? Procedure exists Procedure established established Does your company have Calibration 5: Policy/ 3: Informal system 1: No Policy/ 13 Policy/Procedure? Procedure exists Procedure N/A established established Does your company have a Control of 5: Policy/ 3: Informal system 1: No Policy/ Nonconforming Procedure exists Procedure 14 Material/Product/Service (NCR) established established Policy/Procedure? Does your company have a Corrective 5: Policy/ 3: Informal system 1: No Policy/ and Preventive Action (CAPA) and Procedure exists Procedure 15 Complaint Handling established established Policy/Procedure? Does your company have a Handling, 5: Policy/ 3: Informal system 1: No Policy/ Storage, Packaging, and Delivery Procedure exists Procedure 16 Policy/Procedure? established established N/A Does your company have a Statistical 5: Policy/ 3: Informal system 1: No Policy/ 17 Techniques and Sampling Plan Procedure exists Procedure Policy/Procedure? N/A established established Does your company have a Process 5: Policy/ 3: Informal system 1: No Policy/ 18 Validation Policy/Procedure? N/A Procedure exists Procedure established established Does your company have a Risk 5: Policy/ 3: Informal system 1: No Policy/ Management Policy/Procedure? Procedure exists Procedure 19 established established Does your company have an 5: Independent 3: Quality 1: No Quality 20 independent quality Quality Department is not Department organization/department? Department independent Supplier Questionnaire Completion (To be completed by Supplier) Sign: Print: Supplier’s Representative Date: Title: Questionnaire Return Instructions Please return completed Supplier Questionnaire Request via e-mail E-mail: Attn: Supplier Quality Engineering
10 Does your company have work instructions that are used to control manufacturing (or service) processes, inspection operations and product/equipment release testing? 5: Work Instructions established 3: Informal process exists 1: No Work Instructions established 11 Does your company have an Inspection and Testing Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 12 Does your company have a Training Policy/ Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 13 Does your company have Calibration Policy/Procedure? N/A 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 14 Does your company have a Control of Nonconforming Material/Product/Service (NCR) Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 15 Does your company have a Corrective and Preventive Action (CAPA) and Complaint Handling Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 16 Does your company have a Handling, Storage, Packaging, and Delivery Policy/Procedure? N/A 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 17 Does your company have a Statistical Techniques and Sampling Plan Policy/Procedure? N/A 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 18 Does your company have a Process Validation Policy/Procedure? N/A 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 19 Does your company have a Risk Management Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 20 Does your company have an independent quality organization/department? 5: Independent Quality Department 3: Quality Department is not independent 1: No Quality Department Supplier Questionnaire Completion (To be completed by Supplier) Supplier’s Representative Sign: Print: Date: Title: Questionnaire Return Instructions Please return completed Supplier Questionnaire Request via e-mail E-mail: Attn: Supplier Quality Engineering