The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
PDA

View Full Version : Records and Data - Quality, Legal and Other Evidence

  1. Control of Quality Records - What is the required retention time?
  2. Quality Record Retention Time - ISO 9001 vs. CFR 820.180(b)
  3. Interpreting 4.10.5 Inpection & Test Records
  4. Calibration Records - 4.11.3 - Records of the calibration activity shall include...
  5. Quality Records - Storage - Interpreting the requirement
  6. 4.16 File Index per department? List used as the Record Control List (4.16)?
  7. Quality Records - PO's (Purchase Orders) - Life of part + 1 Year
  8. Can you define keeping quality records at a minimum of 3 years?
  9. 4.16 Quality Records - Retention - Customer Purchase Orders (POs)
  10. 4.6.2.2. Records of premium freight - Anybody who have a true explanation?
  11. If records are cited in procedures, do they have to be cited in work instructions?
  12. Records of Premium Freight (4.6.2.2)
  13. Are production samples quality records?
  14. Training Records - At what point is training required to be documented?
  15. Paperless Electronic Document and Records Systems Software
  16. What are Classified as Quality Records?
  17. Quality Records - What is classified as a Quality Record?
  18. Training records vs experience and education
  19. Record Retention - QS-9000 Element 4.5
  20. Writing a procedure on how to store electronically (computer) generated records
  21. Retention of Quality Records - NC for "access and disposal of quality records"
  22. Control of Quality Records - What are the quality records required by QS-9000?
  23. Safety Forms, Records and Policies
  24. ISO 14000 - Required Quality Records
  25. Electronic Records for FDA - Canned computer program for our Corrective Action system
  26. Quality Records and Forms - No formal forms
  27. Recording training of staff in new/revised procedures
  28. 4.5 Engineering Change record of implementation into production
  29. Control of Quality Records, 4.16, there is the reference to "collection"
  30. 4.16 - Procedure for control of quality records
  31. Exactly how high in the organization is it necessary to have training records?
  32. Training Records - Do all employees have to be trained on ISO 9001:2000?
  33. Is a purchase order (active, haven't put into production) a file or record?
  34. List of Quality Records (Categories) Required by ISO 9001:2000
  35. ISO 14001 - Clause 4.4.5 - Record Retention Periods - How do I determine?
  36. Preventive Actions - Necessary to show either preventive action report or record?
  37. Implementing a Paperless Documentation, Forms and Records System
  38. Defining Record Retention Times - Is 5 years long enough?
  39. How far does one go to protect quality and other records from "loss"
  40. Electronic Records and Signatures - 21 CFR Part 11
  41. Access to records - Defining who has access to what
  42. Training Records and Competency - Seeking sample training record
  43. The Use Of White-Out on Quality and Other Records
  44. Date & initials for cross outs of records?
  45. ISO 9001 Audit Manday and New Records Requirements
  46. Evidence of Disposition and Disposal of Quality and Related Records
  47. Electronic Document and Records Control Software
  48. ISO 15489 Records Management Standard
  49. Does your company use or reference level IV documents in their Quality plan?
  50. How do I determine Records Retention Time requirements? Medical Devices
  51. ISO 9001:2000 Clause 4.2.4 - Control of Quality Records - What constitutes a record?
  52. Data Measurement - Where can I purchase a data recording system?
  53. Does anyone have an ISO 9001 Quality Records Matrix to share?
  54. Document vs. Record - What's the Difference under TS 16949?
  55. Deviation Record Retention Requirements
  56. BS 7799 and ISO 17799 document and records - Security Information
  57. Protection of quality records - How are people handling the requirement?
  58. TS 16949 Clause 7.6.2 Calibration Verification Records
  59. Special Purpose Machines - What type of documentation and records are required?
  60. Transition to Electronic Paperless System - How is Record Retention Addressed
  61. Changing Companies: Retention of Records
  62. Effective production control - Records that you maintain on the shop floor
  63. Disposition of Records - Describe HOW records are being disposed of?
  64. Corrective Action - Is the Follow up the Record? 4.2.4
  65. Request: Quick list of Required ISO9k2k RECORD
  66. Records: Electronic E-mail Retention Requirements
  67. Record Retention - NC for keeping records longer than our defined minimum
  68. Quality Records - Retention and Required Controls
  69. AS9100 Quality Record - 4.2.4 simply states Records, not Quality Records
  70. 7.6 investigation - Do most operations always record the gage# on all test reports?
  71. Identifying Quality Documents and Records from Non-Quality
  72. New company - How much quality records history required?
  73. Identification of Quality Records (ISO9001:2000 - 4.2.4) - How?
  74. Trigger Point - Determining When We Can Dispose of Quality Records
  75. 8.2.4 Monitoring and measurement of product - Do I need to record every serial number
  76. Is a not-very-well-kept record better than no record at all?
  77. The Document List and Record List contain...?
  78. Blank Form vs. Completed Form - A document or record?
  79. Need to reference forms and ensuing records?
  80. Contract Firms Keeping Training Records
  81. ISO Training Records - Human resources section
  82. Hardcopy vs. Electronic Training Records - Eliminating Hardcopy Records
  83. Control of Records Definition - Controls needed and the 'disposition' of records
  84. Where are Records listed? A Master Record list?
  85. Records that never were a document...? Shipping Labels and Computer 'Screens'?
  86. Records of continual improvement - How do you keep auditors happy on this topic?
  87. Temporary Bandit, Ad Hoc or Rogue Records, Forms, Data, Documents - How to Justify
  88. Occurance of Non-Conformance, MRB (Material Review Board) and Record keeping
  89. Of all that is recorded, what is listed or controlled?
  90. Guidelines on record retention of obsoleted calibration procedures (Revision History)
  91. What are the minimum quality records required by QS-9000?
  92. Minimum gage verification record - Evidence records of 'verified prior to use'
  93. Please Help me with the Control of records procedure.
  94. Is Key Performance Measure/Indicator a document or a record?
  95. Defined retention time of quality records - ISO 9001:2000 Paragraph 4.2.4
  96. Record Falsification - What clause to raise a non-conformity?
  97. Are Fireproof Cabinets a Regulatory Requirement for record storage? FDA or EU
  98. Electronic Media Storage - What is the shelf life of recorded CDs?
  99. Retention periods for corrective/preventive action records
  100. Certificate of Compliance vs. Conformance - What is the difference?
  101. Retention of vendor surveys - Surveys to our company, sent by our vendors
  102. Here is a List of Records Required by TS 16949
  103. Bombardier Aerospace Imposes Infinite Record Retention Period
  104. Proposed Federal Rules On E-Document Destruction - Fed. R. Civ. P. 37
  105. 4.2.4 Control of Records - Can someone please clarify "...and disposition of records"
  106. Validation Protocol for a paperless system?
  107. Records Retention Requirements - ISO 13485 retention time of records
  108. AS9100 - Is Record Location Necessary?
  109. Help me define way of control electronic data files - Logs, etc
  110. What do suppliers define as Documents of external origin? TS16949 Para 4.2.3 f)
  111. Traceability - No traceability records back to the supplier - Electronic Components
  112. How much objective evidence is required for ISO9000 certification?
  113. Information/Instruction Signs that refer to controlled documents - FDA Environment
  114. Master List of records - for multiple projects/departments in a software industry
  115. Receiving inspection: Part and Vendor history - your favorite format/application?
  116. Records are a special type of document - Can anyone clarify this statement? 4.2.3
  117. Retention of records - Original Order Form vs. Computer Entry record - ISO 13485
  118. Post production inspection records needed? Inspected by Albert! Mufflers
  119. 4.2.4 Control of Records - Registered to ISO9001:2000, ISO 13485 and AS9100
  120. Evidence - what you do when the relevant function is missing
  121. What are typical records of different documents required by ISO9001?
  122. Lot Tracking - Automotive Requirements - Identification and Traceability
  123. Using Excel .xls spreadsheet to replace paper logsheets - Has anyone had success?
  124. Required records destroyed - Secretary cleaned it out and threw everything away
  125. Certifications (Certificate) of calibration - Where do I need to have them?
  126. Are email acceptable as records? Email for a customer approval of some part?
  127. How to Control Electronic Records
  128. Retain machine setup forms from each run?
  129. Information Retention Requirements for Canadian Organisations
  130. Missing Records, Document Control and Canned Document Content Issues
  131. Oracle computer records - Special procedure for dealing with non-paper Records?
  132. Integrity in reporting, and Poorly defined Tolerances and Requirements
  133. Quality records kept "off site", is it ok or not?
  134. Records of Obsolete Medical Device(s) for Contract Manufacturers
  135. Machine Build Records Retention Requirements
  136. Record Retention - Obsolete revisions shall be maintained until the next revision
  137. Legal document statement that the document is a "Legal and Binding Document"
  138. Customer Furnished Drawings Retained? Control of Documents of External Origin
  139. Preventive Maintenance - Electronic Records Deleted/Erased OR Are Records Required?
  140. What Records to Show Competence for ISO9001 Clause 6.2.1?
  141. Record Control - Who are the Record Custodian and Retention Times - ISO9001 - 7.5.3
  142. Machinist's Journeyman's Card a Training Record?
  143. Rules of Use of 'For "Reference Only" Drawings' - We Assemble Fastening Tools
  144. Records required by TS16949 - I have identified 26, are there more?
  145. Document Control of Training Work Instructions question
  146. Confirming 7.6 - Computer software to satisfy the intended application
  147. Facsimile Signatures on Certificate of Conformance
  148. ISO 9001 Requirements for Warehousing Data (Records) - Medical Device Distributor
  149. Record Storage Box Label - What should I include on the box label?
  150. Training Records - Proof of "training" per ISO 9001 section 6.2.2 (b)
  151. Training Records - Confidential?
  152. Minimum retention or the date of destruction of a record - ISO 9001-2000 Para. 4.2.4
  153. Environmental conditions per ASME NQA-1 2000 QA records?
  154. Records - Are weekly purchasing reports, backlog reports, etc., Quality Records?
  155. How detailed should an equipment maintenance record made by engineer be?
  156. Is there a minimum retention time for any of the Quality Records? ISO9001
  157. The difference between External Records vs. Internal Records
  158. Records: Should they be stamped and should ALL be listed on the Master List?
  159. Material Certifications - Require for All Material or Just When Cust Req's
  160. Record Requirements in AS 9100 7.4.3 Verification of purchased product
  161. Data Protection Act that publishes information within the general factory area
  162. Clarification of Required Records by ISO 9001:2000
  163. Dimensional checks on Work Instructions that are not on Control Plan
  164. How long do you maintain (retain) calibration records?
  165. How do I control all the records we have? What do I put on a matrix?
  166. Appropriate Retention Periods - Digital linacs (linear accelerators)
  167. Record Retention Time of Part Life + 1 Year
  168. How to handle the integrity of electronic data in databases?
  169. Defined Records Retention Time Of Customer/Regulatory Requirements
  170. Define Documents/Records needed for the QMS?
  171. Documenting Machine Shop In-Process Checks
  172. Action on Quality Records - Approve, Update and Carry Out Revision Control
  173. Customer Requirements related to Retention Documents and Records period
  174. Electronic Records Transmission to Customers
  175. Electronic Training Records which show Evidence that People have been Trained
  176. Retention Period of Dead Time Sheets
  177. The meaning of "Retrieval" of Records - ISO 9001 Clause 4.2.4
  178. Email Retention and Binning - How to handle Emails for Retention purposes
  179. Testing an Inspector to Prove Competency in Visual Inspection
  180. Control of Records limited to ISO 9001 Required Records - ISO 9001 Clause 4.2.4
  181. Control of Records retained outside ISO 9001 Scope
  182. Can we destroy original paper files before retention period if we scan them?
  183. Rectification and/or Corrections to existing 'incomplete' records
  184. Customer Satisfaction - Objective Evidence AS9100, para. 5.2, 7.2.2, 7.2.3, 8.2.1
  185. Scrap Logs - Do Scrap Logs have to have a document number?
  186. Control of Disposition of Records - Record Retention - TS 16949 Clause 4.2.4.1
  187. Excel .xls Log for Records Instead of Paper Forms
  188. Uncontrolled Inspection Report Templates
  189. ISO 9001:2000 4.2.3- Quality Records, Production Travelers