AS9101D Checklist for AS9100C

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

4.1 General Requirements

• 01. A QMS has been established, documented, implemented & maintained with evidence of continual effectiveness improvement. (CTS Quality Manual)

  Yes

  No

  N/A

• 03. The QMS addresses customer, statutory & regulatory requirements. (QM Sect 1 / 1.0)

  Yes

  No

  N/A

• 04. a) QMS processes have been determined & applied. (QM Sect v)

  Yes

  No

  N/A

• 05. b) Sequence & interaction determined for QMS processes. (QM Sect v)

  Yes

  No

  N/A

• 06. c) Crieria & methods determined to effectively operate & control QMS processes. (QM for criteria, QSP for methods)

  Yes

  No

  N/A

• 07. d) Availability of resources & information necessary to support the operation & monitoring available for QMS. (QM Sect 2 / 1.3.1.6)

  Yes

  No

  N/A

• 08. e) QMS processes are monitored, measured & analyzed. (QM Sect 2 / 1.8 and Sect 16)

  Yes

  No

  N/A

• 09. f) Actions implemented to continually improve planned results. (QM Sect 14 and Sect 1 / 5.4)

  Yes

  No

  N/A

• 10. Processes are managed in accordance with applicable AQMS standards. (AS9100 per QM Sect 1)

  Yes

  No

  N/A

• 11. Outsourced processes are defined & controlled. List outsourced processes.

  Yes

  No

  N/A

4.2.1 General Documentation Req'ts

• 12. a) Documented statement of a quality policy. (QM Sect ii, posters)

  Yes

  No

  N/A

• 13. a) Documented quality objectives. List quality objectives with goals.

  Yes

  No

  N/A

• 14. b) Documented quality manual. List QM revision.

  Yes

  No

  N/A

• 15. c) Documented procedures required by 9100 standard. (QSP 3-002 Document Control; QSP 12-001 Records; QSP 16-001 Audits; QSP 13-001 Nonconforming Parts; QSP 14-001 Corrective Action)

  Yes

  No

  N/A

• 16. c) Documented records required by 9100 standard. (Management Review, training, PO Review, vendor approval, process validation, calibration, audits, measurements, nonconforming parts, corrective/preventive actions)

  Yes

  No

  N/A

• 17. d) Necessary documents & records as per clause 4.2.1.d.

  Yes

  No

  N/A

• 19. Accessibility & awareness of personnel of relevant QMS documentation & changes.

  Yes

  No

  N/A

4.2.2 Quality Manual

• 20. A Quality Manual is established and maintained, and ...

  Yes

  No

  N/A

• 21. ... includes the scope of the QMS.

  Yes

  No

  N/A

• 22. ... includes justification of exclusions. List excluded clauses. (Design and Post-Delivery Servicing: QM Sect 19 and 20)

  Yes

  No

  N/A

• 23. ... includes QMS documented procedures or reference to them.

  Yes

  No

  N/A

• 24. ... includes a description of the QMS processes & interactions. (QM Sect v)

  Yes

  No

  N/A

4.2.3 Control of Documents

• 35. Documents required by the QMS are controlled.

  Yes

  No

  N/A

• 36. Records are controlled in accordance with clause 4.2.4.

  Yes

  No

  N/A

• 37. Documented procedure exists & includes the following: a) approval process (QSP 3-002 / 4.1)

  Yes

  No

  N/A

• 38. b) review, update & re-approval process (QSP 3-002 / 12.2)

  Yes

  No

  N/A

• 39. c) identification of changes & current revision status (QSP 3-002 / 12.3)

  Yes

  No

  N/A

• 40. d) documents are available where needed (QSP 3-002 / 12.7 and 12.8)

  Yes

  No

  N/A

• 41. e) documents are legible and identifiable (QSP 3-002 / 12.4)

  Yes

  No

  N/A

• 42. f) external documents are identified and controlled (QSP 3-002 / 12.6)

  Yes

  No

  N/A

• 43. g) obsolete documents are identified and controlled. (QSP 3-002 / 12.5)

  Yes

  No

  N/A

4.2.4 Control of Records

• 44. Records (as required in 4.2.4) are established & controlled.

  Yes

  No

  N/A

• 45. A documented procedure exists that includes controls for the following: -identification (QSP 12-001 / 4.1.2 and 4.2.1.1)

  Yes

  No

  N/A

• 46. -storage (QSP 12-001 / 4.0)

  Yes

  No

  N/A

• 47. -protection (QSP 12-001 / 4.0)

  Yes

  No

  N/A

• 48. -retrieval (QSP 12-001 / 2.3)

  Yes

  No

  N/A

• 49. -retention (QSP 12-001 / 3.0)

  Yes

  No

  N/A

• 50. -disposition (QSP 12-001 / 4.1.1 and 4.2.1.3)

  Yes

  No

  N/A

• 51. -records created &/or retained by suppliers (QSP 12-001 / 2.1.8 and CTS PO Spec)

  Yes

  No

  N/A

• 52. Records are legible, identifiable & retrievable. List samples of records reviewed.

  Yes

  No

  N/A

5.1 Management Commitment

• 56. Evidence of top management commitment includes the following: a) communicating the importance of meeting customer, statutory and regulatory requirements (QM Sect 2 / 1.3.1.2)

  Yes

  No

  N/A

• 57. b) establishing a quality policy (QM Sect ii)

  Yes

  No

  N/A

• 58. c) establishing quality objectives (QM Sect 1 / 5.8)

  Yes

  No

  N/A

• 59. d) conducting management reviews (QM Sect 2 / 1.6)

  Yes

  No

  N/A

• 60. e) ensuring availability of resources (QM Sect 2 / 1.3.1.6)

  Yes

  No

  N/A

5.2 Customer Focus

• 63. Top management ensures the following: -customer requirements are determined & met (QM Sect 2 / 1.3.1.2)

  Yes

  No

  N/A

• 64. -product conformity is measured (QM Sect 2 / 1.3.1.8)

  Yes

  No

  N/A

• 65. -on-time delivery performance is measured (OTD report)

  Yes

  No

  N/A

• 66. -actions are taken if planned results are not or will not be achieved

  Yes

  No

  N/A

5.3 Quality Policy

• 67. Top management ensures that the quality policy: a) is appropriate (QM Sect ii)

  Yes

  No

  N/A

• 68. b) includes a commitment to comply with requirements & continually improve the effectiveness of the QMS

  Yes

  No

  N/A

• 69. c) provides a framework to establish & review its quality objectives

  Yes

  No

  N/A

• 70. d) is communicated & understood

  Yes

  No

  N/A

• 71. e) is reviewed for suitability.

  Yes

  No

  N/A

5.4.1 Planning: Quality Objectives

• 72. Top management ensures that quality objectives are established. (QM Sect 1 / 5.8)

  Yes

  No

  N/A

• 73. Top management ensures that quality objectives are measurable. (QM Sect 1 / 5.8)

  Yes

  No

  N/A

• 74. Top management ensures that quality objectives are consistent with the quality policy. (QM Sect 1 / 5.8)

  Yes

  No

  N/A

5.4.2 QMS Planning

• 75. a) Top management ensures the QMS planning is carried out to meet the requirements defined in clause 4.1 & the quality objectives. (QM Sect 2 / 1.3.1.3)

  Yes

  No

  N/A

• 76. b) Top management ensures the QMS integrity is maintained when changes occur. (QM Sect 2 / 1.3.1.4)

  Yes

  No

  N/A

5.5.1 Responsibility and Authority

• 80. Top management ensures that responsibilities & authorities are defined. (QM Sect 2, job descriptions)

  Yes

  No

  N/A

• 81. Top management ensures that responsibilities & authorities are communicated. (QM on eDoc)

  Yes

  No

  N/A

5.5.2 Management Representative

• 84. Top management appointed Management Representative exists. (QM Sect 2 / 1.5, Quality Manager job description)

  Yes

  No

  N/A

• 85. Management Representative's responsibility & authority include: a) ensuring QMS processes are established, implemented & maintained. (QM Sect 2 / 1.5)

  Yes

  No

  N/A

• 86. b) reporting QMS performance (QM Sect 2 / 1.5)

  Yes

  No

  N/A

• 87. c) promoting customer requirements awareness (QM Sect 2 / 1.5 and 1.4.19)

  Yes

  No

  N/A

• 88. d) organizational freedom & unrestricted access to top management for resolution of quality management issues. (QM Sect 2 / 1.5 and 1.3.10)

  Yes

  No

  N/A

5.5.3 Internal Communication

• 90. Top management ensures communication processes are established & takes place on the effectiveness of the QMS.

  Yes

  No

  N/A

5.6.1 Management Review: General

• 91. Top management reviews the QMS for suitability, adequacy & effectiveness at planned intervals. (QM Sect 2 / 1.6)

  Yes

  No

  N/A

• When was the last Management Review held?

  Date

• 92. Management Review records are maintained. List Review records examined.

  Yes

  No

  N/A

5.6.2 Management Review Input

• 94. Inputs to Management Reviews include: a) audit results

  Yes

  No

  N/A

• 95. b) customer feedback

  Yes

  No

  N/A

• 96. c) process performance & product conformity

  Yes

  No

  N/A

• 97. d) preventive and corrective actions

  Yes

  No

  N/A

• 98. e) follow up actions from previous reviews

  Yes

  No

  N/A

• 99. f) changes that could possibly affect the QMS

  Yes

  No

  N/A

• 100. g) improvement recommendations.

  Yes

  No

  N/A

5.6.3 Management Review Output

• 104. Management Review outputs include: a) QMS process improvements

  Yes

  No

  N/A

• 105. b) customer requirement related product improvements

  Yes

  No

  N/A

• 106. c) identification of resource needs.

  Yes

  No

  N/A

6.1 Provision of Resources

• 112. Resources are determined & provided to: a) implement & maintain the QMS & improve its effectiveness (QM Sect 2 / 1.3.1.6 and QM Sect 15 / 1.0)

  Yes

  No

  N/A

• 113. Resources are determined & provided to b) enhance customer satisfaction (QM Sect 15 / 1.0)

  Yes

  No

  N/A

6.2.1 Human Resources, General

• 115. Personnel competency is based on education, training, skills & experience. (QSP 15-001, QM Sect 15)

  Yes

  No

  N/A

6.2.2 Competence, Training and Awareness

• 118. a) Competence for personnel affecting product quality is determined. (Job descriptions)

  Yes

  No

  N/A

• 119. b) Training to achieve competence is provided. (QSP 15-001)

  Yes

  No

  N/A

• 120. c) Evaluates effectiveness of actions taken.

  Yes

  No

  N/A

• 121. d) Ensures personnel are aware of the relevance & importance of their activities & contribution to realizing quality objectives.

  Yes

  No

  N/A

• 122. e) Maintains appropriate records per clause 6.2.2 requirements.

  Yes

  No

  N/A

6.3 Infrastructure

• 126. Determine, provide & maintain an infrastructure needed to achieve product conformity including: a) buildings, workspace & associated utilities

  Yes

  No

  N/A

• 127. b) process equipment

  Yes

  No

  N/A

• 128. c) supporting services.

  Yes

  No

  N/A

6.4 Work Environment

• 130. Determine & manage the work environment needed to achieve product conformity.

  Yes

  No

  N/A

7.1 Planning of Product Realization

• 131. Plan & develop consistent product realization processes. (QSP 5-001)

  Yes

  No

  N/A

• 132. Product realization planning reflects the following: a) quality objectives & product requirements

  Yes

  No

  N/A

• 133. b) processes, documents & resources

  Yes

  No

  N/A

• 134. c) verification, validation, monitoring, measurement, inspection & test activities (QSP 8-001)

  Yes

  No

  N/A

• 135. d) records

  Yes

  No

  N/A

• 136. e) product configuration (QSP 15-001 / Purpose)

  Yes

  No

  N/A

• 137. f) resources.

  Yes

  No

  N/A

• 138. Planning is in a suitable form for the organization's operations.

  Yes

  No

  N/A

7.1.1 Project Management

• 141. Product realization is planned & managed in a structured & controlled manner to meet requirements at acceptable risk. (QSP 5-001 / Purpose)

  Yes

  No

  N/A

7.1.2 Risk

• 142. Establish, implement & maintain a process for managing risk. (QSP 1-002)

  Yes

  No

  N/A

• 143. Risk management includes, as appropriate to the organization & product: a) responsibilities for risk management (QSP 1-002 / 1.1)

  Yes

  No

  N/A

• 144. b) definition of risk criteria (QSP 1-002 / 2.0)

  Yes

  No

  N/A

• 145. c) identification, assessment & communication of risks (QSP 1-002 / 3.1)

  Yes

  No

  N/A

• 146. d) identification, implementation & management of actions to mitigate risks that exceed risk acceptance (QSP 1-002 / 4.0)

  Yes

  No

  N/A

• 147. e) acceptance of remaining risks after implementation of mitigating actions. (QSP 1-002 / 5.0)

  Yes

  No

  N/A

7.1.3 Configuration Management

• 148. Establish, implement & maintain a configuration management process that includes, as appropriate to the product: (QSP 1-003)

  Yes

  No

  N/A

• 149. a) configuration management planning (QSP 1-003)

  Yes

  No

  N/A

• 150. b) configuration identification (QSP 1-003 / 3)

  Yes

  No

  N/A

• 151. c) change controls (QSP 1-003 / 4)

  Yes

  No

  N/A

• 152. d) configuration status accounting (QSP 1-003 / 5)

  Yes

  No

  N/A

• 153. e) configuration audits. (QSP 1-003 / 6)

  Yes

  No

  N/A

7.1.4 Control of Work Transfers

• 154. Establish, implement & maintain a process to plan & control work transfers including: (QSP 6-001 / 4.3)

  Yes

  No

  N/A

• 155. - temporary or permanent transfers

  Yes

  No

  N/A

• 156. - verification of work conformity to requirements.

  Yes

  No

  N/A

7.2.1 Determination of Requirements Related to the Product

• 157. a) Determine customer requirements, including delivery & post-delivery activities. (QSP 4-001 and QSP 4-002 / 10)

  Yes

  No

  N/A

• 158. b) Determine requirements not stated by the customer,but necessary for specified or intended use. (QSP 5-001 / 2.0)

  Yes

  No

  N/A

• 159. c) Determine applicable statutory & regulatory requirements. (QSP 5-001 / 2.0)

  Yes

  No

  N/A

• 160. d) Determine any additional necessary requirements. (QSP 5-001 / 2.0)

  Yes

  No

  N/A

7.2.2 Review of Requirements Related to the Product

• 161. Reviews product requirements prior to commitment to supply a product. (QSP 4-001, QSP 4-002, QSP 5-001)

  Yes

  No

  N/A

• 162. Reviews conducted to the customer documentation to ensure: a) product requirements are defined (QSP 4-001 / 2.2 and QSP 4-002 / 2.3.1)

  Yes

  No

  N/A

• 163. b) differing contract requirements are resolved (QSP 4-002 / 2.3.3)

  Yes

  No

  N/A

• 164. c) organization has the ability to meet the requirements

  Yes

  No

  N/A

• 166. d) special product requirements are determined

  Yes

  No

  N/A

• 167. e) risks have been identified (QSP 4-002)

  Yes

  No

  N/A

• 168. Records of reviews & actions are maintained. List records examined.

  Yes

  No

  N/A

• 169. Where the customer provides no documented requirements they are confirmed before acceptance. (QSP 5-001 / 1.0)

  Yes

  No

  N/A

• 170. Documents are amended & personnel made aware when product requirements are changed. (QSP 4-002 and QSP 5-001)

  Yes

  No

  N/A

7.2.3 Customer Communication

• 172. Implements effective customer communications for: a) product information (QSP 13-001 and QSP 5-006)

  Yes

  No

  N/A

• 173. b) enquiries, contracts or order handling (QSP 4-001 and QSP 5-006)

  Yes

  No

  N/A

• 174. c) customer feedback. (QSP 14-002)

  Yes

  No

  N/A

7.3 Design - justified exclusion

7.4 Purchasing Process

• 219. Purchased product conforms to specified requirements. (QSP 6-001)

  Yes

  No

  N/A

• 220. Responsibility evident for product conformity for all purchased products (including product from customer directed suppliers). (QSP 6-001 / 2.1)

  Yes

  No

  N/A

• 223. Criteria for selection, evaluation & re-evaluation of suppliers are established. (QSP 6-001 / 2.8.2 & 2.8.3)

  Yes

  No

  N/A

• 224. Records of evaluations & actions arising from the evaluations are maintained. (QSP 6-001 / 2.8.2.1)

  Yes

  No

  N/A

• 225. a) Register of approved suppliers including scope of approval is available. (QSP 6-001 / 2.2 and Approved Vendor List)

  Yes

  No

  N/A

• 226. b) Supplier performance is periodically reviewed. (QSP 6-001 / 2.8)

  Yes

  No

  N/A

• 227. c) Process for dealing with suppliers that do not meet requirements is defined. (QSP 6-001 / 2.8.3)

  Yes

  No

  N/A

• 228. d) The organization & all suppliers use customer-approved special process sources. (QSP 6-001 / 2.6)

  Yes

  No

  N/A

• 229. e) The process, responsibilities & authority for the approval status decision, changes & conditions for controlled use are determined. (QSP 6-001 / 2.8.3.3 & 2.8.2.1)

  Yes

  No

  N/A

• 230. f) The risk when selecting & using suppliers is determined & being managed. (QSP 1-002 / 4.3)

  Yes

  No

  N/A

7.4.2 Purchasing Information

• 233. Purchasing in formation includes (where appropriate): a) product, procedures, processes & equipment approvals (QSP 6-001 / 3.1.1)

  Yes

  No

  N/A

• 234. b) personnel qualifications (QSP 6-001 / 3.1.2)

  Yes

  No

  N/A

• 235. c) QMS requirements (QSP 6-001 / 3.1.3 and CTS PO Spec 1.1)

  Yes

  No

  N/A

• 236. d) revision status relevant technical data (QSP 6-001 / 3.1.4 and CTS PO Spec 2.2)

  Yes

  No

  N/A

• 237. e) requirements for design, test, inspection, verification, use of statistical techniques & related instructions for acceptance (including critical items & key characteristics) (QSP 6-001 / 3.1.5)

  Yes

  No

  N/A

• 238. f) requirements for test specimens (QSP 6-001 / 3.1.6)

  Yes

  No

  N/A

• 239. g) requirements for suppliers to notify of nonconforming product; receive nonconforming product disposition approvals; notify of changes to product, processes, suppliers & facilities; and flow down requirements (QSP 6-001 / 3.1.7 - 3.1.9 and CTS PO Spec 2.1 & 1.5)

  Yes

  No

  N/A

• 240. h) records retention requirements (CTS PO Spec 2.3)

  Yes

  No

  N/A

• 241. i) right of access (QSP 6-001 / 3.1.11 and CTS PO Spec 4.0)

  Yes

  No

  N/A

• 246. Adequacy of purchase requirements prior to issuance. (QSP 6-001 3.4 and QSP 6-005)

  Yes

  No

  N/A

7.4.3 Verification of Purchased Product

• 247. Activities to ensure purchased product meets purchase requirements have been established & implemented. (QSO 5-009 and QSP 6-001 4)

  Yes

  No

  N/A

• 248. A process of product recall is implemented when product is released for use prior to completion of required incoming verification. (QSP 6-001 / 4.1)

  Yes

  No

  N/A

• 249. Requirements for supplier delegations are defined & a register of delegations is maintained. (N/A for CTS)

  Yes

  No

  N/A

• 250. Purchasing information defines information about the verification activities at the supplier's premises. (N/A for CTS)

  Yes

  No

  N/A

7.5.1 Control of Production & Service Provision

• 251. Production & service provisions are planned & achieved under controlled conditions including: (QSP 5-001 and QSP 5-006)

  Yes

  No

  N/A

• 252. a) availability of product characteristics

  Yes

  No

  N/A

• 253. b) availability of necessary work instructions

  Yes

  No

  N/A

• 254. c) use of suitable equipment

  Yes

  No

  N/A

• 255. d) Availability & use of monitoring & measurement (M&M) equipment.

  Yes

  No

  N/A

• 256. e) implementation of monitoring & measurement

  Yes

  No

  N/A

• 257. f) implementation of product releases, delivery & post-delivery (QSP 5-006, QSP 7-001, QSP 8-001 - delivery & post-delivery not applicable to CTS)

  Yes

  No

  N/A

• 258. g) accountability for all product during production (routers)

  Yes

  No

  N/A

• 259. h) evidence that all operations have been completed as planned (QSP 5-006 / 5.3, routers)

  Yes

  No

  N/A

• 260. i) provisions for a Foreign Object Debris/Damage (FOD) program (QSP 5-022)

  Yes

  No

  N/A

• 261. j) monitoring & control of utilities & supplies (QSP 5-001 / 3.0)

  Yes

  No

  N/A

• 262. k) criteria for workmanship (QSP 5-001 /3.4)

  Yes

  No

  N/A

• 267. Planning appropriately considers: - managing critical items & key characteristics (QSP 5-001 / 3.0 and 3.4)

  Yes

  No

  N/A

• 268. - measurement tooling (QSP 5-001 / 3.0 and 3.4)

  Yes

  No

  N/A

• 269. - identifying in-process verification points (QSP 5-001 / 3.0 and 3.4)

  Yes

  No

  N/A

• 270. - special processes (thermal spray, paint, dry film lube, shot peen are special processes used by CTS)

  Yes

  No

  N/A

7.5.1.1 Production Process Verification

• 271. A representative item from the 1st production run is used to verify production processes, documentation & tooling and is capable of producing parts & assemblies that meet requirements. (QSP 5-006 / 11)

  Yes

  No

  N/A

7.5.1.2 Control of Production Process Changes

• 273. Personnel authorized to approve changes are defined. (QSP 5-001 / 7.0)

  Yes

  No

  N/A

• 274. Changes affecting processes, equipment, tools or software are controlled & documented.

  Yes

  No

  N/A

• 275. Changes are assessed to confirm that product conformity has not been adversely affected. (QSP 5-001 / 11.0)

  Yes

  No

  N/A

7.5.1.3 Control of Production Equipment, Tools and Software

• 276. Production equipment, tools & software used to automate, control or monitor processes are validated prior to release for production & are maintained.

  Yes

  No

  N/A

• 279. Storage requirements are defined for production equipment or tooling.

  Yes

  No

  N/A

7.5.1.4 Post-Delivery Support - justified exclusion

7.5.2 Validation of Processes for Production and Service Provision

• 285. Special processes are validated prior to use. (VSE, source substantiation)

  Yes

  No

  N/A

• 286. Special process validations demonstrate the ability to achieve planned results.

  Yes

  No

  N/A

• 287. Established arrangements include, as applicable: a) criteria for review & approval

  Yes

  No

  N/A

• 288. b) approval of equipment & qualification or personnel (QSP 3-001 and QSP 3-005)

  Yes

  No

  N/A

• 289. c) use of specific methods & procedures

  Yes

  No

  N/A

• 290. d) requirements for records (QSP 12-001)

  Yes

  No

  N/A

• 291. e) revalidation.

  Yes

  No

  N/A

7.5.3 Identification and Traceability

• 292. Products are identified throughout product realization. (QSP 5-006 - routers)

  Yes

  No

  N/A

• 293. Product configuration is maintained. (QSP 1-003)

  Yes

  No

  N/A

• 294. Product status is identified throughout product realization. (routers, nonconformance tags)

  Yes

  No

  N/A

• 295. Controls are in place for media used for acceptance. (Q-067 Stamp Log)

  Yes

  No

  N/A

• 296. When required traceability is controlled through unique product identifications & records are maintained.

  Yes

  No

  N/A

7.5.4 Customer Property

• 298. Customer property is adequately controlled through identification, verification, protection & safeguarding.

  Yes

  No

  N/A

• 299. Lost, damaged or product unsuitable for use is reported to the customer & records maintained. (QSP 13-001)

  Yes

  No

  N/A

7.5.5 Preservation of Product

• 301. Products are preserved during internal processing & delivery. (QSP 7-001)

  Yes

  No

  N/A

• 302. Preservation includes identification, handling, packaging, storage & protection. (QSP 7-001)

  Yes

  No

  N/A

• 303. Preservation controls are applied to the constituent parts.

  Yes

  No

  N/A

• 305. Preservation of product includes, as appropriate, a) cleaning (QSP 5-003)

  Yes

  No

  N/A

• 306. b) foreign object controls (QSP 5-022)

  Yes

  No

  N/A

• 307. c) special handling for sensitive products (N/A for CTS)

  Yes

  No

  N/A

• 308. d) marking & labeling (N/A for CTS)

  Yes

  No

  N/A

• 309. e) shelf life control & stock rotation (QSP 5-010)

  Yes

  No

  N/A

• 310. f) special handling for hazardous materials (N/A for CTS for product)

  Yes

  No

  N/A

7.6 Control of Monitoring and Measuring (M&M) Equipment

• 312. Product M&M and appropriate M&M equipment have been determined. (QSP 10-001)

  Yes

  No

  N/A

• 313. A register of the M&M equipment is maintained. (GagePack software)

  Yes

  No

  N/A

• 314. Processes are defined for M&M equipment calibration (&/or verification), including equipment type, identification, location, frequency, check method & acceptance criteria. (QSP 10-001, "Q" procedures)

  Yes

  No

  N/A

• 315. M&M can be and are carried out consistent with the M&M requirements.

  Yes

  No

  N/A

• 316. Environmental conditions are suitable for the calibrations, inspections, measurements & testing being carried out. (QSP 10-001 / 4.2)

  Yes

  No

  N/A

• 317. a) M&M equipment are calibrated (&/or verified) at specified intervals against traceable standards. (QSP 10-001 / 1.2 & 1.0)

  Yes

  No

  N/A

• 318. b) M&M equipment are adjusted when necessary. (QSP 10-001 / 4.3)

  Yes

  No

  N/A

• 319. c) M&M equipment have unique identifiers. (QSP 10-001 / 2.2 & 4.6)

  Yes

  No

  N/A

• 320. d) M&M equipment are safeguarded from adjustments (QSP 10-001 / 1.0)

  Yes

  No

  N/A

• 321. e) M&M equipment are adequately protected.

  Yes

  No

  N/A

• 322. A M&M equipment calibration (&/or verification) recall process exists. (QSP 10-001)

  Yes

  No

  N/A

• 323. Previous results are assessed, recorded and acted upon when M&M equipment is found to be out of conformance. (QSP 10-001 / 11.0)

  Yes

  No

  N/A

• 324. Calibration (&/or verification) records are retained. (QSP 12-001)

  Yes

  No

  N/A

• 325. Software used for M&M is confirmed before initial use & reconfirmed as necessary. (QSP 10-001 / 4.8)

  Yes

  No

  N/A

8.1 General Measurement, Analysis and Improvement

• 327. Monitoring, measurement, analysis & improvement processes are planned & implemented to a) demonstrate product conformity

  Yes

  No

  N/A

• 328. b) ensure QMS conformity

  Yes

  No

  N/A

• 329. c) improve QMS effectiveness

  Yes

  No

  N/A

• 330. Applicable methods (including statistical techniques) have been determined & are being used. List examples of methods:

  Yes

  No

  N/A

8.2.1 Customer Satisfaction

• 331. Methods for obtaining/using customer perception data are in place. (QSP 4-003)

  Yes

  No

  N/A

• 332. Customer satisfaction information includes product conformity, on-time delivery, customer complaints & corrective action requests.

  Yes

  No

  N/A

• 333. Improvement plans to address customer satisfaction deficiencies are in place.

  Yes

  No

  N/A

8.2.2 Internal Audit

• 334. Internal audits are conducted at planned intervals. (QSP 16-001 / 2.0)

  Yes

  No

  N/A

• 335. a) Audits ensure conformity to planned arrangements, requirements of the AS9100 standard & the organization's QMS requirements. (QSP 16-001 / 1.1 & 1.2)

  Yes

  No

  N/A

• 336. b) Audits ensure the QMS is effectively implemented & maintained. (QSP 16-001 / Purpose)

  Yes

  No

  N/A

• 337. Audits are based on the status & importance of processes & previous audit results to defined criteria, scope, frequency & methods. (QSP 16-001 / 2.4)

  Yes

  No

  N/A

• 338. Auditors do not audit their own work. (QSP 16-001 / 3.2)

  Yes

  No

  N/A

• 339. A documented internal audit procedure exists. (QSP 16-001)

  Yes

  No

  N/A

• 340. Audit records are maintained. (QSP 16-001 / 4.4)

  Yes

  No

  N/A

• 341. Timely corrective actions are taken by management in audited areas. (QSP 16-001 / 4.2)

  Yes

  No

  N/A

• 342. Follow-up activities verify & report actions taken. (QSP 14-001 / 6.0)

  Yes

  No

  N/A

8.2.3 Monitoring and Measurement (M&M) of Processes

• 343. Methods for M&M of QMS processes are in place & demonstrate that the processes achieve planned results.

  Yes

  No

  N/A

• 344. Correction & corrective actions are taken when results are not achieved.

  Yes

  No

  N/A

• 345. Process nonconformities result in: a) actions to correct the nonconforming process (QSP 13-001 / 2.2.3)

  Yes

  No

  N/A

• 346. b) evaluation of the effect on products (QSP 14-001 / 2.7)

  Yes

  No

  N/A

• 347. c) determination of the effect on other processes or products (QSP 14-001 / 2.7)

  Yes

  No

  N/A

• 348. d) control of nonconforming product. (QSP 13-001)

  Yes

  No

  N/A

8.2.4 Monitoring and Measurement (M&M) of Product

• 349. M&M of product characteristics are performed & maintained. (QSP 8-001)

  Yes

  No

  N/A

• 351. Acceptance measurement requirements are documented and include: (technical plans & routers)

  Yes

  No

  N/A

• 352. a) acceptance &or rejection criteria

  Yes

  No

  N/A

• 353. b) the sequence where measurement & testing operations are planned

  Yes

  No

  N/A

• 354. c) records of measurement results

  Yes

  No

  N/A

• 355. d) specific measurement instruments required

  Yes

  No

  N/A

• 357. Critical items are controlled & monitored. (QSP 5-001 / 3.0)

  Yes

  No

  N/A

• 358. Sampling plans are justified on the basis of recognized statistical principles & appropriate for use.

  Yes

  No

  N/A

• 360. Product released for use prior to the completion of planned activities is controlled to allow for recall. (QSP 5-006 / 8.2)

  Yes

  No

  N/A

• 361. Records reflect the person(s) authorizing the release of product for delivery.

  Yes

  No

  N/A

• 362. Records show that products meet defined requirements.

  Yes

  No

  N/A

• 363. Release of product &/or delivery of services are not performed until all planned activities are accomplished or without authority/customer approval. (QSP 5-006 / 8.2)

  Yes

  No

  N/A

• 364. Documents required to accompany the product are present at delivery. (QSP 5-006)

  Yes

  No

  N/A

8.3 Control of Nonconforming Product (NCP)

• 369. NCP is identified & controlled.

  Yes

  No

  N/A

• 370. A documented procedure exists for handling of NCP. (QSP 13-001)

  Yes

  No

  N/A

• 371. The responsibility & authority for the review & disposition of NCP are defined. (QSP 13-001 / 1.1)

  Yes

  No

  N/A

• 372. The process for approving personnel making these decisions is defined. (QSP 13-001 / 2.2.6 & 2.2.7)

  Yes

  No

  N/A

• 373. NCP controls include: a) actions to eliminate the nonconformity (QSP 13-001 / 2.2.3)

  Yes

  No

  N/A

• 374. b) use, release or acceptance by customer concession (QSP 13-001 / 2.2.1 & 4.1)

  Yes

  No

  N/A

• 375. c) actions to preclude its intended use or application (QSP 13-001 2.1)

  Yes

  No

  N/A

• 376. d) actions on the effects of NCP, when detected after delivery or use, including timely reporting (QSP 13-001 / 3.4)

  Yes

  No

  N/A

• 377. e) actions to contain the nonconformity effect on other process or products. (QSP 14-001 / 2.7)

  Yes

  No

  N/A

• 378. Dispositions of use-as-is or repair is used only after approval from design responsible organization. (QSP 13-001 / 4.1)

  Yes

  No

  N/A

• 379. Dispositions of use-as-is or repair are not used without customer authorization. (QSP 13-001 / 4.1)

  Yes

  No

  N/A

• 380. Scrap product is marked or positively controlled. (QSP 13-001 / 2.2.4)

  Yes

  No

  N/A

• 381. Corrected NCP is re-verified. (QSP 5-011 / 3.1)

  Yes

  No

  N/A

• 382. NCP records are maintained. (QSP 12-001)

  Yes

  No

  N/A

8.4 Analysis of Data

• 383. Data to demonstrate the suitability & effectiveness of the QMS is determined, collected & analyzed.

  Yes

  No

  N/A

• 384. Analysis of data includes customer satisfaction.

  Yes

  No

  N/A

• 385. Analysis of data includes conformity to product requirements.

  Yes

  No

  N/A

• 386. Analysis of data includes characteristics & trends of processes & products.

  Yes

  No

  N/A

• 387. Analysis of data includes supplier performance.

  Yes

  No

  N/A

8.5.1 Continual Improvement

• 389. The QMS is continually improved trough the quality policy, quality objectives, audit results, analysis of data, corrective/preventive actions and management review.

  Yes

  No

  N/A

• 390. Improvements & the evaluation of effectiveness are monitored.

  Yes

  No

  N/A

8.5.2 Corrective Action

• 391. Actions are taken to eliminate the causes of nonconformities.

  Yes

  No

  N/A

• 392. A documented procedure exists that includes: (QSP 14-001)

  Yes

  No

  N/A

• 393. a) reviewing of nonconformities (QSP 13-001 / 1.1)

  Yes

  No

  N/A

• 394. b) determining the causes of nonconformities (QSP 14-001 / 2.6)

  Yes

  No

  N/A

• 395. c) evaluating action to prevent recurrence (QSP 14-001 / 2.8)

  Yes

  No

  N/A

• 396. d) determining & implementing actions (QSP 14-001 / 2.8)

  Yes

  No

  N/A

• 397. e) record of actions taken

  Yes

  No

  N/A

• 398. f) reviewing the effectiveness of corrective action (QSP 14-001 / 6.0)

  Yes

  No

  N/A

• 399. g) flowing down corrective action requirements to suppliers (QSP 14-001 / 2.4 and CTS PO Spec)

  Yes

  No

  N/A

• 400. h) actions where timely &or effective corrective actions are not achieved (QSP 14-001 / 2.7)

  Yes

  No

  N/A

• 401. j) determining if additional nonconforming product exists. (QSP 14-001 / 2.7)

  Yes

  No

  N/A

8.5.3 Preventive Action

• 403. Actions are taken to eliminate the causes of potential nonconformities.

  Yes

  No

  N/A

• 404. A documented procedure exists that includes: (QSP 14-001)

  Yes

  No

  N/A

• 405. a) determining potential nonconformities & their causes (QSP 14-001 / 5.1)

  Yes

  No

  N/A

• 406. b) evaluating action to prevent occurrence (QSP 14-001 / 2.8)

  Yes

  No

  N/A

• 407. c) determining & implementing action (QSP 14-001 / 2.8)

  Yes

  No

  N/A

• 408. d) record of actions taken

  Yes

  No

  N/A

• 409. e) reviewing the effectiveness of preventive action (QSP 14-001 / 6.0)

  Yes

  No

  N/A