Friday, October 5, 2012

Tips on documentation and record keeping

Good documentation is essential part of the quality assurance system.
  • CLEARLY written documentation prevent errors from spoken communication and permits traceability.
  • Documents should be designed, prepared, reviewed and distributed with CARE. They should comply with rules and regulations.
  • Title, nature, purpose and contents should be CLEARLY STATED. They should be laid out in an orderly fashion and be easy to check.
  • Documents should be APPROVED, SIGN and DATED by appropriate and AUTHORIZED  person.
  • ALL procedures being used within a company, are APPROVED by related experts are CONSISTENT with other documents and are in the most CURRENT or updated version. Authorized Quality Assurance personnel usually is the last person to sign on the document to verify and approve.
  •  ALL documents: current, obsolete, superseded as well as all the history on creation and revision of the document are kept by Quality Assurance following the document retention period.
  • Data may be recorded by electronic data processing systems, photographic or other reliable means or methods. However, detailed procedures relating to the system in use should be available. In addition, the accuracy of the records should be checked. 
  • If documentation is handled by electronic data processing methods, only AUTHORIZED persons should be able to enter or modify data in the computer. A record of CHANGES and DELETIONS should be available. Access should be RESTRICTED by passwords or other means. The results of entry of CRITICAL DATA should be independently CHECKED. Back ups must be available. Data must be readily AVAILABLE throughout the retention period.
  • Documents should be REGULARLY REVIEWED and kept UP-TO-DATE. When a document has been revised and approved, systems should be operated to PREVENT inadvertent use of superseded documents.
  • Documents should not be hand written; although, where documents need the entry of data, these entries may be made in CLEAR, LEGIBLE and INDELIBLE handwriting. Sufficient space should be provided for such entries.
  • Practice yourself to ALWAYS record ALL necessary information IMMEDIATELY upon completion of each task. This is to avoid from forgetting to record the details of the necessary information and to avoid any mistakes. Remember, no matter whether you are so busy or whether you don't have enough time, you have to do this. Never compromise. If you compromise, you'll be in trouble! .
  • NEVER trust your memory. You will never remember everything in details.
  • SIGN, DATED and write your NAME legibly in ink. Remember that by signing records, you are certifying that the record is correct and that you have performed the task as per the defined procedure. NEVER sign a document without reading the contents of the document.
  • DRAW a SINGLE line through any mistakes, SIGN and DATE the alteration or correction. The alteration should PERMIT the reading of the original information. INCLUDE a REASON for the correction near the mistakes or note at the bottom of the page.
  • Reproduced documents should be CLEAR and LEGIBLE. The reproduction of working documents from master documents must NOT allow any error or mistake to be introduced through the reproduction process.
  • NEVER write any results or records or important details on loose pieces of paper. Because, you may lost it.
  • DON'T document someone else's task/work unless you are designated and trained to do so.
  • NEVER assume that undocumented work has been properly completed. If it is not written down, then it didn't happen! (although actually it has been completed). If something goes wrong, you can't proof that the work has been properly completed if it is not documented.
  • NEVER lie or manipulate data/records. It is essential to keep ACCURATE records. During an audit, it helps convey that you are following procedures. It also demonstrates that processes are known and under control. Quality Assurance ensures that all documents are maintained and controlled.
  • ALWAYS follow APPROVED procedures. Should a deviation occurs, all changes and deviations must be recorded.
  • ALWAYS record details when you deviate from a procedure. ALWAYS ask your supervisor/superior or the Quality Department for advice should a deviation occurs.
Never waver from it,
even when you don't see
how you can afford to keep it up.
When you compromise, 
you become a commodity, 
and then you die!"
~Gary Hirshberg