New hire orientation good documentation practice presentation

New hire orientation good documentation practice presentation

• 1.
  Documentation in Food Manufacturing In a GMP Environment
• 2.
  Introduction •Good Documentation Practice is a Requirement but What does it Mean??? • Not only is Good documentation a requirement but it protects our employees and our company.
• 3.
  Agenda • Definitions • Whatdepartments use documents? • Who is responsible for creating documents? • Who is responsible for filling out paperwork?
• 4.
  Overview • We workin an FDA environment • Important Items: what do they mean? GDP FDA GMP SQF
• 5.
  TERMS TO REMEMBER •GMP = Good Manufacturing Practice • GDP= Good Documentation Practice • SQF = Safe Quality Food • FDA = Food and Drug Administration
• 6.
  GOOD MANUFACTURING PRACTICE • GMP= Required for every employee. • Examples of GMP • Training required for everyone employed in the Food, Drug, Medical Device and other regulated industries
• 7.
  GOOD DOCUMENTATION • GoodDocumentation Practice • Set of rules to protect and control what we do. • WRITE DOWN WHAT YOU DO OR IT DIDN’T HAPPEN!
• 8.
  SQF • SQF =Safe Quality Foods: • Program to audit our facility, people, processes to be sure we are producing a safe quality product. Audits occur annually.
• 9.
  FOOD AND DRUGADMINISTRATION • Food And Drug Administration: The FDA regulates many industries including ours. We are mandated by them to product a quality product while proving what we do.
• 10.
  Document mistakes • Noone is perfect! We make mistakes. Here is how we deal with them. • 1. If you make a mistake, draw a line through your mistake and write the correct item , date and initial. • 2. Write a brief explanation of the mistake beside the line out. • 3. For errors of a wrong number or letter, write “EE” for entry error. • Please do not use the following: • Write over, white out, pencil (blue or black pen only), legible writing. Remember just because you write it, doesn’t mean no one will read it!
• 11.
  Questions? Please contact yoursupervisor for any questions related to any of the topics discussed in this presentation. Thank you and Welcome to Ainsworth!