Establish Documentation and Record Keeping Principle

3.9.1. Documentation and Record Keeping

A record shows the process history, the monitoring, the deviations, and the corrective actions (including disposition of product) that occurred at the identified CCP. It may be in any form, e.g., processing chart, written record, computerized record. The importance of records to the HACCP system cannot be overemphasized. It is imperative that the producer maintain complete, current, properly filed, and accurate records. Four types of records should be kept as part of the HACCP program:

• Support documentation for developing the HACCP plan.

• Records generated by the HACCP system.

• Documentation of methods and procedures used.

• Records of employee training programs.

3.9.2. Support Documents

The HACCP plan support documents include information and support data used to establish the HACCP plan such as the hazard analysis and records documenting the scientific basis for establishing the CCPs and critical limits (31). Examples include:

• Data used to establish the control measures to prevent microbiological growth.

• Data used to establish the shelf life of the product (if age of the product can affect safety).

• Data used to establish the adequacy of critical limits in ensuring the safety of the product.

The HACCP plan support documents should also include a list of the HACCP team members and their responsibilities, as well as all the forms produced during the preparation of the HACCP plan, showing:

• Product description and intended use.

• Hazard analysis.

• Identification of CCPs.

• Identification of the critical limits for each CCP, including data from experimental studies or information collected to support the critical limits.

• Documented deviation and corrective action plans

• Planned verification activities and procedures.

• Identification of the preventive measures for each hazard.

3.9.3. Records Generated by the HACCP System

HACCP system records are kept to demonstrate adherence of the HACCP system to the HACCP plan. These records are used to demonstrate control at CCPs in the food process. The records generated by the HACCP system include all activities and documentation required by the plan. Monitoring Records for All CCPs

All HACCP monitoring records should be kept on forms that contain the following information:

• Product identification (including product type, package size, processing line, and product code).

• Critical limits.

• Monitoring observation or measurement.

• Operator's signature or initials.

• Corrective action taken, where applicable.

• Reviewer's signature or initials. Deviation and Corrective Action Records

• Identification of the deviant lot/product.

• Amount of affected product in the deviant lot.

• Nature of the deviation.

• Information on the disposition of the lot.

• Description of the corrective action. Verification/Validation Records

• In-house on-site inspection.

• Equipment testing and evaluation.

• Accuracy and calibration of monitoring equipment.

• Results of verification activities, including methods, date, individuals and/or organizations responsible, results or findings, and action taken.

3.9.4. Documentation of Methods and Procedures Used

The producer should maintain records of the methods and procedures used in the HACCP system.

• Description of the monitoring system for the critical limit of each CCP, including the methods and equipment used for monitoring, the frequency of monitoring, and the person performing the monitoring.

• Plans for corrective actions for critical limit violations or situations resulting in potential hazards.

• Description of record-keeping procedures, including copies of all record forms.

• Description of verification and validation procedures.

3.9.5. Records of Employee Training Programs

Records should be kept of all employee training. This is of particular importance for employees involved in monitoring critical limits for CCPs and those involved with deviation review, corrective actions, and verification. These employees must be trained to understand fully the appropriate procedures/methods and actions to be taken regarding control of CCPs (Table 22).

4. Notes

1. The intent of the HACCP system is to focus control at CCPs. Redesign of the operation should be considered if a hazard that must be controlled is identified but no CCPs are found.

2. The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process, or any step. It is important when applying HACCP to be flexible when appropriate, given the context of the application, taking into account the nature and the size of the operation.

3. Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practise, and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP system.

4. HACCP should be applied to each specific operation separately. CCPs identified in any given example in any Codex Code of Hygienic Practice might not be the only ones identified for a specific application or might be of a different nature.

5. During hazard identification, evaluation, and subsequent operations in designing and applying HACCP systems, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern, and epidemiological evidence relative to food safety.


1. Ito, K. (1974) Microbiological critical control points in canned foods. Food Technol. 28, 46-48.

2. Sperber, W. H. (1991) The Modern HACCP System. Chicago, Food Technology, pp. 116-118.

3. The Pillsbury Co. (1981) Food safety through the hazard analysis and critical control point system. The Pillsbury Co. apud Bryan, F. L., Hazard analysis of food Service operations. Food Technol. 35, 78-87.

4. Silliker, J. H. (1986) Principles and applications of the HACCP approach for the food processing industry. In: Proceedings of the 1986 Conference for Food Protection, Food Protection Technology (Felix, C. W., ed.). Lewis Publications, Chelsea, MI, pp. 81-89.

5. Archer, D. L. (1990) The need for flexibility in HACCP. Food Technol. May, 174-178.

6. Bobeng, B. J. and David, B. D. (1977) HACCP models for quality control of entree production in food service systems. J. Food Prot. 40, 632-638.

7 Bryan, F. L. (1984) Análises de riscos nas empresas de alimentos. Higiene Alimentar 3, 92-100.

8. Bryan, F. L. (1990) Application of HACCP to ready-to-eat chilled foods. Food Technol. July, 70-77.

9. Bryan, F. L. (1981) Hazard Analysis Critical Control Point approach: epidemiologic rationale and application to foodservice operations. J. Environ. Health. 44, 7-14.

10. Bryan, F. L. (1992) Hazard Analysis Critical Control Point Evaluations. World Health Organization, Geneva, 1992.

11. Bryan, F. L. (1985) Procedures for local health agencies to institute a hazard analysis critical control point program for food safety assurance in foodservice operations. J. Environ. Health 47, 241-245.

12. Martins, J. P. S. (1983) Aplicagao do Método de Análise de Risco por Pontos Críticos de Controle em Cozinhas Industriais Ministério da Agricultura, SIPA, SIF (Servigo de Inspegao Federal), Brasilia.

13. Puri, S. C. (1995) Qualidade no setor alimenticio. Artigo. Rev. Controle Qualidade 33, 60-61.

14. Apostila do Centro Tecnológico de Madrid/Projeto ARCA Madrid Espanha (CETEMA) (1995) Control Chart. Yamamura Consulting Engineer Office, Japao.

15. FAO (1995) Food and Nutrition Paper No. 58. The use of hazard analysis critical control point (HACCP) principles in food control. Report of an FAO Expert Technical Meeting, Vancouver, Canada, 12-16 December, 1994, FAO, Rome.

16. ICMSF (International Comission on MicrobiologicaL Specifications for Foods). Microorganisms in foods (1988) Application of the Hazard Analysis Critical Control Point system to ensure microbiological safety and quality. Blackwell Scientific Publications, Oxford.

17. Kauffman, F. L. (1974) How FDA uses HACCP. Food Technol. 28, 84.

18. Portaria 1428/Ministério da Saúde (1993) Publicado no "Diário Oficial da Uniao/DOS".

19. Bauman, H. E. (1990) HACCP: concept, development, and application. Food Technol. May, 153-158.

20. Bauman, H. E. (1974) The HACCP concept and microbiological hazard categories. Food Technol. 29, 30-74.

21. Haberstroh, C. (ed.) (1988) HACCP: making the system work. Food Eng. Aug, 70-80.

22. Ishikawa, K. (1983) Guide to Quality Control, Industrial Engineering and Technology, 2nd ed. Asian Productivy Organization, Tokyo.

23. Bryan, F. L. (1988) Hazard analysis critical control point: what the system is and what it is not. J. Environ. Health 50, 400-401.

24. Bryan, F. L. (1974) Microbiological food hazards today based on epidemiological information. Food Technol. 28, 52, 54, 58-60, 62, 64, 66, 84.

25. Bryan, F. L.(1988) Risks associated with vehicles of foodborne pathogens and toxins. J. Food Protection 51, 498-508.

26. Bryan, F. L. (1988) Risks of practices, procedures and processes that lead to outbreaks of foodborne diseases. J. Food Protection 51, 663-673.

27. Campos, V. F. (1992) TQC: Controle da Qualidade Total (no estilo japones).4th ed. Fundagao Christiano Ottoni, Belo Horizonte.

28. Campos, V. F. (1994) TQC: Gerenciamento da Rotina do Trabalho do Dia-a-dia, 2nd ed. Fundagao Christiano Ottoni, Belo Horizonte.

29. Harrington, H. J. (1991) Business Process Improvement: The Breakthrough Strategy for Total Quality, Productivity, and Competitiveness. McGraw Hill, New York.

30. Hradeski, J. L. (1989) Aperfeigoamento da Qualidade e da Produtividade: Guia Prático para Implementagäo do Controle Estatístico de Processo CEP. McGraw-Hill, Sao Paulo.

31. Monteiro, J. G. D. M. (1994) Gerenciamento de Processos Empresariais: Interface direta com o Processo Produtivo. Trabalho de Mestrado, UFSC.

32. Paladini, E. P. (1995) Gestao da Qualidade no Processo: a qualidade na Produgao de Bens e Servigos. Atlas, Sao Paulo-SP.

33. Pinto, J. L. G. C. (1993) Gerenciamento de Processos na Industria de Móveis. Trabalho de Mestrado, UFSC.

34. CCDAM (Comittee on Communicable Diseases Affecting Man) (1991) Procedures to Implement the Hazard Analysis Critical Control Point System. International Association of Milk, Food and Environmental Sanitarians, Ames, IA.

35. Huss, H. H. (1993) Assurance of seafood quality. FAO Fisheries Technical Paper. FAO, Rome.

36. Bryan, F. L. (1981) Hazard analysis of food service operations. Food Technol. 35,78-87.

37. de Carvalho, A. B. M. and Frosini, L. H. (1995) CEP de tendencias em processos continuos. Artigo. Rev. Controle Qualidade 33, 63, 64, 66.

38. Jay, J. M. (1992) Modern Food Microbiology, 4th ed. Chapman & Hall, New York.

39. NCR. Executive summary. An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. Food Protection Commitee/Subcommitee on Microbiological Criteria/National Research Council/National Academy of Sciences, Washington DC.

40. Bauman, H. E. (1974) The HACCP concept and microbiological hazard categories. Food Technol. 29, 30-74.

41. Leitao, M. F. F. (1995) Análise de perigos e pontos críticos de controle, conceitos e definigöes. In: Seminário Sobre Análise de Riscos e Pontos Críticos de Controle (ARPCC) na Industria de Pescado e Derivados. CIAL/ITAL, Campinas, pp. 1-11.

42. Stevenson, K. E. (1990) Implementing HACCP in the food industry. Food Technol. May, 179-180.

42a. Shampton, N. (1989) Implementing a food safety programme. Food Manufacture 17, 47-50.

43. Dellaretti Filho, O. and Drumond, F. B. (1994) Itens de Controle e Avaliacao de Processos. Fundacao Christiano Ottini, Belo Horizonte, 1994.

44. Spencer G. III, E. and Hudak-Roos, M. (1991) Development of an HACCP-based inspection system for the seafood industry. Food Technol. Dec, 53-57.

44b. Avery, S. M., Hudson, J. A., Phillips, D. M. (1976) Use of response surface models to predict bacterial growth from time temperature histories. Food Control 7, 121-128.

44c. Lund, B. M., Baird-Parker, T. C., and Gould, G. W. (2000) The Microbial Safety and Quality of Food. Apsen, Gaithersburg, MD.

45. Spencer G. III, E. and Hudak-Roos, M. (1990) Use of HACCP for seafood surveillance and certification. Food Technol. May, 159-168.

46. Corlett Jr., D. A. (1991) Regulatory verificationa of industrial HACCP systems. Food Technol. Apr, 144-146.

47. Peterson, A. C. Gunnerson, R. E. (1974) Microbiological Critical Control Points in frozen foods. Food Technol. 28, 37-44.

48. Beauregard, M. R., Mikulak, R. J., and Olson, B. A. (1991) A Practical Guide to Statistical Quality Improvement: Opening up the Statistical Toobox. Van Nostrand Reinhold, New York.

49. Doty, L, A. (1990) Statistical Process Control, 1st ed. ASQC-Quality Press Book by Industrial Press, New York.

50. Grant, E. L. (1964) Statistical Quality Control, International Student Edition, 3rd ed. McGraw-Hill, New York.

51. Kume, H. (1988) Statistical Methods for Quality Improvement. AOTS-The Association for Overseas Technical Scholarship Japäo.

52. Lourengo Filho, R. de C. B. (1982) Controle Estatístico de Qualidade. LTC Livros Técnicos e Científicos Editora., Rio de Janeiro. Manual de Boas Práticas de Fabricagäo para Industrias de Alimentos. Sociedade Brasileira de Tecnologia de Alimentos (SBCTA) Campinas, SP, 1991.

53. Rihmer, J, F., Spencer, A. (1989) Controle Estatístico de Processos (CEP). Apostila, Joinville, SC.

54. Tompkin, R. B. (1990) The use of HACCP in the production of meat and poultry products. J. Food Prot. 53, 795-803.

55. Corlett Jr., D. A. (1989) Refrigerated foods and use of hazard analysis and critical control point principles. Food Technol. 43, 91-94.

56. Hajadenwurcel, J. R. (1996) Apostila do "Curso de Análise de Perigos e Pontos Críticos de Controle na Indústria de Laticínios," citado por Santos, J. A. dos. HACCP é Garantia de Qualidade. Rev. Industria Laticínios. I, 16-20.

57. NFPA (1989) Factors to be considered in stablishing Good Manufacturing Practices for the production of refrigerated foods, National Food Processors Assn., apud Corlett, D. A.. Refrigerated foods and use of Hazard Analysis and Critical Control Point principles. Food Technol. 43, 91-94.

58. USHEW (1989) Proceeding of the 1971 National Conference on Food Protection. US Department of Health, Education, and Welfare, Washington, DC, apud Corlett, D. A. (1989) Refrigerated foods and use of Hazard Analysis and Critical Control Point principles. Food Technol. 43, 91-94.

Was this article helpful?

0 0


  • banazir
    What is record keeping in microbiology?
    4 years ago

Post a comment