Documentation course
- 1. Documents and Records - Module 16 1 Scenario • Inspection Reports • Quality Manual • Audit Results • Standard Operation Procedures (SOPs) • Summary of Audit findings from on-site Audits • report of corrective actions • Non conformances form (blank form) • Quality Control record (blank form) • Daily Maintenance log (completed) • Stock Cards and Stock Book (completed) • ETC You have found all these papers lying on a desk. Which of these are documents and which are records?
- 2. Why do Organizations need to manage documents and records? To find information whenever it is needed! provides individuals with the information to perform a job properly ensure permanence irrespective of personnel change/turnover provide concise set of requirements facilitate consistency of quality activities facilitate monitoring activities and quality system audits Documents and Records - Module 16 2
- 3. Why do Organizations need to manage documents and records? It minimizes opportunities for miscommunication When historical data are being evaluated for current use, documents can also be valuable convey requirements simultaneously to all concerned personnel facilitate effective change control indicate compliance with organizational governmental requirements Documents and Records - Module 16 3
- 4. Documents and Records - Module 16 4 Documentsand Records—Howdo they differ? ISO 9000:2005 Documents Information and the supporting media communicate information via policies, processes, and procedures need updating Records Evidences of activities performed capture information on worksheets, forms, labels, and charts permanent, do not change RECORDS
- 5. 5 Clarity index Theclarityindexisameasureoftheeaseordifficultyofreading apieceofwriting.Theprocessismechanicalandobjective. CI = SL + LW% SL - Average sentence length (total words/sent =15) LW% - Percentage of long words ( ≤3 syllables =15) (Sample approximately 200 words) • CI>40 - text difficult to understand • CI<20 - text abrupt & impolite • CI~30 - typical conversation or press article CHARACTERISTICS OF A DOCUMENT
- 6. Documents and Records - Module 16 6 Numbering System •need uniform numbering system •do not change a current system that works one system: •Org/Loc-Dept-Doc type-Serial number- Rev status
- 7. Why Document Control Documents and Records - Module 16 7 assures that the most current version is used ensures availability when needed organizational tool
- 8. Documents and Records - Module 16 8 Common Document Control Problems •outdated documents •too many documents are distributed and the system cannot be maintained •lack of control of documents of external and internal origin •Lack of a central control of documents •Lack of communication of requirements
- 10. Documents and Records - Module 16 10 Policies - The “WHAT TO DO” “A written statement of overall intentions and directions defined by those in the organization and endorsed by management.” Policies: tell “what to do” in a broad and general way include the organizational mission, goals, and purpose serve as the framework for the quality system should always be specified in the quality manual
- 11. Documents and Records - Module 16 11 Processes- The “HOWIT HAPPENS” A “set of interrelated or interacting activities that transform inputs into outputs.” (ISO 9000 4.3.1) Processes: • describe the steps involved to carry out quality policies • easily represented in flow charts • involve a series of steps, usually occurring over a period of time
- 12. Documents and Records - Module 16 12 Procedures- The “HOWTO DO IT” Procedures, Standard operating procedures (SOP) step-by-step instructions for performing a single activity Job aid a shortened version of the SOP does not replace the SOP Work Instruction a detailed version of the SOP does not replace the SOP Needed where more information is required
- 14. 14 Documents for work processes should be accessible to staff at the work site : • instructions on performing activities • SOPs required by Standard • SOPs required by Organisation • Quality manuals
- 15. Documents and Records - Module 16 15 Standard Operating Procedures (SOPs) are documents that: describe how to perform a activities using step-by-step instructions written SOPs help ensure: •consistency •accuracy •quality
- 16. 16 Examples of Purpose: This procedure defines the minimum steps required for creation and control of information and documentation for PRN in compliance with the requirements of ISO 9001:2008 Quality Management System Standard. To eliminate the cause of existing nonconformities in order to prevent recurrence To identify the method of accessing the legal and other regulatory requirements applicable to PRN’s operations and the up-date of the Register of legal regulations requirements.
- 17. Documents and Records - Module 16 17 Document Preparation and Control Process Preparation Review Issue Distribution Revision Approval