LOT CONTROL AND TRACEABILITY. 13.1 IMS Buhrke Xxxxx ships lots per purchase order date, this becomes the traceability and identifier for the lot. The suppliers system shall ensure that product is processed FIFO according to PO date. Identification at the supplier using labels or tags and listing the part number, purchase order number and net quantity is required for each container.
LOT CONTROL AND TRACEABILITY. 9.1 RTI shall establish and maintain procedures for identifying and tracking each Implant by suitable means from donor through all stages of production and to final consignee or final disposition.
LOT CONTROL AND TRACEABILITY. Raw Materials 28
LOT CONTROL AND TRACEABILITY. Commercial Off The Shelf (COTS), Customer Furnished Materials (CFM) Items 28 98. Calibration Report 29 99. Calibration Certification 29 100. Source Inspection Required 29 101. Source Surveillance Required 30 102. Government Source Surveillance 30 103. FAA Surveillance 30 104. Control Plan/Locked Process 30 105. Drawing and Change Control 31 106. Process Procedures and Documentation 31 107. Inspection, Test and Acceptance 31 108. Inspection Report 31 109. Inspection Report – Xxxxxx Machine Company Format 32 110. First Article Inspection Required/Maintained – AS9102 Required 32 111. First Article Inspection Plan Required 33 112. First Article Inspection Plan 33 113. As-Built Record or Log 33 114. Supplying Controlled Shelf Life Material 33 115. Material Safety Data Sheet (MSDS or SDS) 33 116. Process Flow and PFMEA Required and Maintained 34 117. Raw Material Approval Prior to Manufacturing of Product 34 118. 3rd Party Independent Inspection/Testing 34 119. Control of 3rd Party Independent Inspection/Testing 34 120. Control of Special Processes and Certification 34 121. Inspection Equipment – Supplier Furnished 35 122. Inspection Equipment – Buyer Designated 35 123. Safety Critical Characteristic Calibration Period and No Due Date Extension 36 124. Statistical Process Control / Capability Analysis 36 125. Characteristics Not Verifiable Upon Receipt 37 126. Inspection Sampling Plan C=0 37 127. Honeywell SPOC 128 Inspection Sampling Plan 38 128. Non-destructive Evaluation (NDE) 40 129. No Glass Beads 40 130. Weld Schedule 40 131. No halogenated Solvents 40 132. Supplier Record Retention – X years 40 133. Military Specification Cancellation 41 134. Foreign Object Damage or Debris Prevention (FOD) 41 135. Plated Components, Assemblies and Mechanical Items 42 136. Packaging Time, Temperature, Static Discharge, or Environmentally Sensitive Items 42 137. Packaging Returned Product and Test Articles/Coupons, etc 42 138. Electrostatic Discharge Protection (ESD) 42 139. As-Built Configuration List 42 140. Shelf Life Requirements – Xxxxxx Machine Company Consumable Material 42 141. Shelf Life Reporting for Supplier Used Material 43 142. Hazardous Materials 43 143. Training 43 144. Sub Tier Procurement 43 145. Sub tier Supplier Evaluation, Selection, and Monitoring 44 146. Annual Validation 44 Xxxxxx Machine Company SQAR Preface This manual contains requirements that are applicable when invoked by Xxxxxx Machine Company Purchase Orders. Requirements include the mandator...
LOT CONTROL AND TRACEABILITY. Commercial Off The Shelf (COTS), Customer Furnished Materials (CFM) Items The Supplier (and any sub tier) shall provide a traceability matrix of items consumed and/or assembled to complete the part listed on the Purchase Order. This may be provided as an Excel document or within the CofC from the Supplier. The traceability matrix must contain the following at a minimum:
