A famous saying goes like “If it isn’t documented, it didn’t happen”- therefore, it becomes mandatory for all food processors, ingredient manufacturers, and packaging suppliers to develop, document, implement and maintain all necessary documentation in order to maintain Food Safety Management System for establishing business in global level. Nowadays, even small businesses are expected to maintain documentation, or else they will fail to display FSMS in their premises. This need of proper document and record keeping has led to the birth of Good Documentation Practices (GDP) or Good Record Keeping Practices.
A. Good Documentation Practices-An Introduction
Good Documentation Practices is a mandate requirement for overall quality management systems (QMS) and risk management strategies (QRM). These are referred to, as practices that collectively and individually ensure documentation (whether paper or electronic) is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate. These practices have direct or indirect impact on all aspects of the quality of food substances/products and demonstrate evidence of adherence to GMP standards and/or any other applicable regulatory requirements. Good Document Practices help in achieving HACCP, FSSC 22000, HALAL, GFSI, BRC, SQF and other certifications and thus helps in gaining confidence of customers apart from complying to required guidelines.
B. Need of GDP
Following GDP in one’s food facility ensures-
- defined specifications and procedures for all materials being handled in facility,
- defined methods of manufacture and control,
- awareness in operators and all personnel – what to do and when to do it,
- proper flow of information among team, necessary for release of product,
- documented evidence, traceability, records and audit trail for investigation,
- availability of data for validation, review and statistical analysis
C. Basic Features for documentation
C.1. Attributable: Capturing information in the record form such that it is uniquely identified and used as per requirement on time.
C.2 Legible: Captured data should always be readable, understandable and should allow understanding of sequencing of steps or events in the record.
C.3. Contemporaneous: Process of documentation (on paper or electronically) at the time of the occurrence of an activity
C.4. Original: The data captured at source of data or information and should be fully reconstruct the conduct of the GMP activity.
C.5. Accurate: Data in documents should be correct, truthful, valid and reliable.
C.6. Complete: All data from analysis, including any data generated before a problem is observed, data generated after repeating part or all of the work, or re-analysis performed on the sample should be included in the data record.
C.7. Consistent: All elements of the analysis, such as the sequence of events, follow on and data files are date-stamped (all processes) and time stamped (when using a hybrid or electronic system) in the expected order and such data should be included in the record.
C.8. Enduring: All data recorded on authorized media should be preserved for a period of time, Data recorded on scrap paper or any other media which can be discarded later (e.g., backs of envelopes, laboratory coat sleeves or Post-It notes, etc.) are not considered enduring
C.9. Available: The complete collection of records should be available, accessed or retrieved for review and audit or inspection over the lifetime of the record.
D. Documentation Process:
- Preparation of Document:
- All Documents must be accurate, consistent, completed and must be traceable.
- Pages in the master document must be numbered as A of C (e.g., Page 25 of 50).
- All documents must have the signature and date of the person who prepared, reviewed and approved the document.
- All documents must have an effective date and a review period if applicable.
- Full text spelling with the abbreviations in brackets must be used for the first time. Abbreviations must be used in place of full text spelling in the remaining part of the document.
- Definitions shall be included in the document for reference. This is most effectively done by including the definitions in a table format, at the start or end of the document.
- All documents shall have a unique identification number (including the version number).Use of uncontrolled documents and temporary recording practices (e.g., scraps of paper) shall be prohibited.
- Review and Approval of Documents
- Documents within the Quality Management System to be regularly reviewed and kept up to date.
- Unsigned or incomplete documents or records not be used to perform any task or considered as evidence of a completed task.
- All GDP documents to be approved by Quality Assurance Manager.
- Issuance of GDP documents
- Records shall be maintained for issuance and retrieval of documents with proper traceability of the person who issued the document.
- Master copies of controlled documents (paper-based and electronic) must be stored in a secure manner and accessible only to authorized individuals.
- Recording/data capture on GMP documents
- Handwritten entries to be made in a clear, legible, indelible manner.
- Indelible ballpoint pen to be used to record data. Pencil or erasable or water-soluble ink pen shall not be used to complete the GMP documents.
- Use of white ink, correction fluid or sticky notes (e.g., post-it notes) to correct the entry in GMP documents shall not be permitted.
- Entries shall always be recorded at the time of activity in a contemporaneous manner. Date and time of completion of activity to be recorded in a predefined standard format as found suitable by the firm. The format of date and time should remain consistent throughout all the documentation formats across the firm. In case a printout generated by equipment/instrument/system has a different format, it shall be converted to the standard format while entering in logbooks/GMP documents.
- Data to be recorded only in the format duly issued and approved by Quality Assurance.
- Logbooks shall be kept for major or critical analytical testing, production equipment, areas where product has been processed and other usage logs.
- If there is any repetition in any observation/signature/date then it should be rewritten again. Avoid using markings such as Ditto (–”–), “as above” or “do” shall not be used.
- Handwritten signatures must be unique to the individual and listed within the Specimen signature register to ensure that the signature is traceable to the concerned
- Any employee should not be permitted to sign for another member of staff unless delegated. Signatures must never be forged.
- A single strike-out line must be used always to mark the incorrect entry in such a manner that original entry remains readable.
- There shall be pre-defined retention periods for different sets of documents. An inventory of documents within the quality management system should be maintained.
- Revision of documents
- All revised documents shall mention its revision history.
- Periodic reviews of controlled documents and forms shall be done as per approved procedure and shall be handled through a change approval process.
- Versions of documents created shall be managed through logbooks.
- A record shall not be destroyed before its stated retention period or validity without appropriate justification and consultation with Quality Assurance.
- Any approved or under approval document shall not be discarded or destroyed without the appropriate stamp authorizing cancellation/obsolescence.
Documentation helps to build up a detailed map of what manufacturing function has done in the past and what it is doing now and thus provides the foundation of what it will do in future. GDP must be incorporated as an essential component of FSMS in all small and large-scale food industries and appropriate care must be taken to ensure its compliance with regulatory bodies.