Establishment of DICS for MacPlas Presentation.pptx

Documented Information

1. Establishment of Documented Information for MacPlas 1

2. Objectives At the end of the session, the participants will be able to: Enable to establish and maintain an effective documented information control system for own organization. Describe and write policies based on the requirements for Food Business Operators (FBO) as per DOH A. O. 153 s. 2004 2

3. DIC Organizational Chart 3

4. 4 Control of Documented Information Process

5. 5 RDND Form

6. Duties and Responsibilities DIC Responsible for ensuring that all documented information related to Management Systems are maintained and is conformance to document control system of the organization. 6

7. Duties and Responsibilities Document Custodian Handles records for their respective departments Review and update Department’s Master List of Documented Information Maintain record retention timelines 7

8. 8 PREPARATION OF GOOD MANUFACTURING PRACTICES (GMP) POLICIES

9. Rationale for GMP IRR of RA 9711: Food and Drug Administration Act of 2009 & A.O. 2014-0029 A food company must be able to prove their capability and capacity to assure food safety and quality through GMP compliance together with other appropriate food safety systems 9

10. DOH A. O. 153 s. 2004 General Guidelines A. GMP Organization B. Premises C. Equipment D. Sanitation and Hygiene E. Production and Process Controls F. Quality Control G. Documentation H. Quality Audits I. Warehousing and Distribution J. Product Recall K. Retention of Sample L. Sub-Contracting of Manufacture M. Product and Information Awareness 10

11. Food Safety System Documents Company GMP Policies SSOP’s /Procedural Plans Work Instructions (WI) Records

12. Contents of the Manual Introduction Objective/s and Scope of the Manual Terms and Definition from DOH A.O. 153 s. 2004 Policies A. GMP Organization B. Premises C. Equipment D. Sanitation and Hygiene E. Production and Process Controls F. Quality Control G. Documentation H. Quality Audits I. Warehousing and Distribution Product Recall Retention of Sample Sub-Contracting of Manufacture Product and Information Awareness 12

13. Introduction Include the following: Brief introduction to the company (name, location, history, products, markets, and other information.) Description of the manual Purpose for preparing the manual 13

14. Objective/s and Scope of the Manual This GMP Policy Manual provides the Good Manufacturing Practices (GMP) policies of (Company Name). These policies are designed to ensure prevention of contamination and serve as a guide for producing safe products. 14

15. A. GMP Organization Include in this section a brief description of the organization; indicate the following: Identify designations of persons in-charge of Production & QA/QC and other functions; important to show that the person in-charge of Production is different from that of QA/QC List duties & responsibilities 15

16. A. GMP Organization 16 GMP POLICY/IES The company has a Production head who is in-charge on production activities, sanitation programs, maintenance programs and others and a Quality Control head who is in-charge of checking the quality/safety specifications of raw materials, processes parameters, and finished goods. REFERENCE DOCUMENTS Organizational Chart, Job Description, Training Files, Certificates, 201 Files D.O.H A.O 153 HEADING A. GMP ORGANIZATION

17. B. Premises Grounds Policies re: maintenance, cleaning & sanitation to protect vs. contamination, such as cleaning, housekeeping, waste management measures being done Example: Plant grounds and premises are kept clean and maintained properly at all times. Plant Construction and Design Describe floors, walls, ceilings, windows, doors, drains, available and describe that “these are designed and constructed to prevent product contamination”. Describe facilities such as lighting, protection vs. pest entry 17

18. B. Premises 18 GMP POLICY/IES The premises of the company are kept clean, maintained in good condition/repair, and orderly. REFERENCE DOCUMENTS Cleaning Procedures, Building/Infrastructure Maintenance Checklist, Integrated Pest Management Plan, Plant Layout D.O.H A.O 153 HEADING B. PREMISES

19. C. E quipment Includes equipment, work surfaces & utensils (Food Contact Surfaces) “Sanitary design”/fabrication Inert materials No-glass policy Safe operation Proper/Designated Equipment lines location Clean, maintained in good condition (consider appropriate cleaning & sanitizing during changeovers to minimize allergen cross contact 19

20. C. Equipment 20 GMP POLICY/IES All Food Contact Surfaces are kept clean and maintained in good condition. REFERENCE DOCUMENTS Cleaning & Maintenance Programs Converting Machine Checksheet D.O.H A.O 153 HEADING C. EQUIPMENT

21. D. Sanitation and Hygiene Personnel Hygiene Requirements: Disease Control Attire & Hygienic Habits Education & Training Water Supply Waste Management 21

22. Personnel – Disease Control A HEALTHY food handler means he is free from : Diseases of the respiratory tract --- cold, sore throat, pneumonia, TB Intestinal disorders --- typhoid fever, infectious hepatitis, diarrhea Skin disorders --- sores, abrasions, visibly infected lesions, infected ears, boils, scabies, severe rashes, cuts and infected wounds Signs of illness : jaundice, vomiting, fever, sore throat with fever, discharges from the ear, eye or nose 22

23. D. SANITATION AND HYGIENE 23 GMP POLICY/IES All food handlers are free from diseases of the respiratory tract, intestinal and skin disorders . REFERENCE DOCUMENTS Prescrive Personnel Attire, Access Guidelines for Controlled Room, Cleaning Programs, Integrated Pest Management Programs, Plant Layout indicating location of Sanitary Facilities, Documents related to Water Supply, Health Monitoring Procedure, Resumption of Work for Post Covid-19 Infection Procedure, Health Card D.O.H A.O 153 HEADING D. SANITATION AND HYGIENE

24. E. PRODUCTION and PROCESS CONTROLS Describe controls done for Raw Materials, Ingredients and, other Inputs, including Packaging Materials, Process controls, and Controls for Finished Goods. Include controls for rework, re-processing, temporarily-stored goods if applicable 24

25. E. PRODUCTION AND PROCESS CONTROL 25 GMP POLICY/IES REFERENCE DOCUMENTS Production & Process Manuals, Production & Process Records, Quality Control Manuals & Records D.O.H A.O 153 HEADING E. PRODUCTION AND PROCESS CONTROL

26. F. QUALITY CONTROL Describe QC system in place in the company. Include tests done either by in-house (if available) or external laboratory facilities 26

27. F. QUALITY CONTROL 27 GMP POLICY/IES The company has a Quality Control program covering raw materials, ingredients and other inputs, in-line processing, and finished products to ensure product quality and safety. REFERENCE DOCUMENTS QA/QC Manuals & Records, Laboratory Tests/Reports Files, Quality Plan, Specification Sheets, Control of Nonconforming Output Procedure, Monitoring Form, CAR D.O.H A.O 153 HEADING F. QUALITY CONTROL

28. G. DOCUMENTATION Written specifications for materials, processes and products Written Procedures (e.g. Production, Quality Assurance/Control) - GMP policies, Sanitation SOPs - Monitoring records - Document management & control Describe the documentation done in the company 28

29. G. Documentation 29 GMP POLICY/IES Written specifications for materials, products and processes are available. Monitoring records are prepared and kept on file . REFERENCE DOCUMENTS Process Manuals, GMP Manuals , RDND, Quality Manual, Documented Information Control Procedure D.O.H A.O 153 HEADING G. DOCUMENTATION

30. H. QUALITY AUDITS Prepare the policies re: audits conducted 30

31. H. Quality Audits 31 GMP POLICY/IES REFERENCE DOCUMENTS Audit Programs, Audit Reports, Audit Procedures, Training Certificates , CAR Procedure D.O.H A.O 153 HEADING H. QUALITY AUDITS

32. I. WAREHOUSING AND DISTRIBUTION Describe Warehousing and Distribution policies – include cleaning and pest prevention and control programs for warehousing areas, stock control systems in place, FIFO, proper labeling, designated areas, security, etc. Policies must be according to the allergen management program 32

33. H. Warehousing and Distribution 33 GMP POLICY/IES Insert your content REFERENCE DOCUMENTS Warehousing and Dispatching Procedures, Integrated Pest Management Plan, Pre-Delivery Inspection Guidelines, Materials Handling & Storage Guidelines, Good Housekeeping Checksheet , Good Warehousing Practices, Pre-Loading Inspection D.O.H A.O 153 HEADING H. WAREHOUSING AND DISTRIBUTION

34. J. PRODUCT RECALL Written procedures for handling complaints Recall procedures; “mock” recall Monitoring records Describe recall & complaints handling program. Examples: 1. Written procedures and records for handling complaints are available. 2. Written recall procedures are available 34

35. J. PRODUCT RECALL GMP POLICY/IES REFERENCE DOCUMENTS Handling Customer Concerns Procedure, Traceability, Product Recall, Mock Recall D.O.H A.O 153 HEADING J. PRODUCT RECALL

36. K. RETENTION OF SAMPLES Product samples are retained to serve as reference samples in case of any product comments, recommendation, or complaint. 36

37. K. RETENTION OF SAMPLES 37 GMP POLICY/IES REFERENCE DOCUMENTS Quality Inspection Procedure D.O.H A.O 153 HEADING K. RETENTION OF SAMPLES

38. L. SUB-CONTRACTING OF MANUFACTURE Describe policies re: subcontracting, duties and responsibilities of parties, written contract If there is no sub-contracting activity, indicate Example: A written contract specifying all conditions of the subcontracting activity, duties and responsibilities of the parties involved, is available and reviewed regularly. 38

39. M. PRODUCT INFORMATION AND AWARENESS Describe policies re: Product Labeling, Lot Identification, Consumer Education/Awareness programs. Note that indication of allergen/s, when present, is a mandatory labeling item and should be included in the Allergen Management program. Example: All products are properly labeled according to FDA A.O. 2014-0030 39

40. M. PRODUCT INFORMATION AND AWARENESS 40 GMP POLICY/IES Insert your content REFERENCE DOCUMENTS Product Label D.O.H A.O 153 HEADING M. PRODUCT INFORMATION AND AWARENESS

41. 41 Sanitation Standard Operating Procedures (SSOP)

42. 42 Prerequisite for HACCP Based on the company GMP Policies Step-by-step instructions on how to perform SSOPs stated Proof of implementation

43. Sanitation Standard Operating Procedures (SSOP) Written procedures on how a company will meet sanitation practices (cGMP) in a food plant in order to prevent product contamination and adulteration Based on company GMP Policies For every KSC/KSA, there should be an established SSOP(s) 43

44. Elements of SSOP Control Measure Measure to address sanitation conditions and practices before, during, and after processing Monitoring Procedures Answers the ff: What , How , When or How often and Who will monitor? Corrective Action Actions to restore sanitary condition 44

45. Elements of SSOP Records Proof of compliance to GMP/hygiene codes Verification Procedures Application of methods, procedures, tests and audits, and monitoring Example: Records review, swabbing, Audits/spot checks 45

46. 10 Key Sanitation Areas/Conditions (KSA/KSC) Safety of Water Supply Condition and Cleanliness of Food Contact Surfaces Prevention of Cross Contamination Adequate Hand washing, Hand Sanitizing & Toilet Facilities Protection of Packaging and FCS from Contamination 6. Labeling, Use & Storage of Chemicals/Toxic Compounds 7. Employee Health Condition should not contaminate food 8. Exclusion of Pests 9. Monitoring system for cleaning and personnel hygiene 10 . Glass, Metal and Hard Plastic control and Monitoring Procedures

47. 47 SSOP CODE SWS-005 TITLE/CONTROL MEASURE Obtaining a Certificate of Potability from the Water District OBJECTIVE To ensure potability of water supply in the processing site MONITORING PROCEDURES   What Potability Certificate from Water District How Visual inspection of the certificate How often/When Get the certificate annually; keep file updated  Who QA Supervisor     CORRECTIVE ACTION When the certificate indicates water is not potable,   1. Apply treatment when possible; or   2. Use an alternative water source from an accredited supplier until the condition is corrected by the Water District.; or   3. Use water from an accredited refilling station.     DOCUMENTS & RECORDS Water Supply File, Sanitation Checklist, WI-SWS-001-1, Certificate of Potability , List of Accredited Suppliers         VERIFICATION Laboratory testing by DOH     Prepared By/Date:   Reviewed By/Date:   Approved By/Date:   SAMPLE SSOP FOR KSC1

48. 48 WORK INSTRUCTION CODE WI - SWS - 005 TITLE/CONTROL MEASURE Obtaining a certificate from water district SCOPE This Work Instruction covers all water used in the processing site     OBJECTIVE To ensure potability of water supply in the processing site     WORK INSTRUCTION (English and other versions)     1. Go to the water district. (Or Contact and set an appointment with the water district   2. Request for issuance of certificate and pay the necessary fees.   3. Get the certificate and keep on file.         Prepared By/Date :   Reviewed By/Date :   Approved By/Date :   SAMPLE WORK INSTRUCTION FOR KSC1 NOTE: NO NEED FOR DAILY CHECK LIST SINCE SSOP: SWS-005 IS DONE ANNUALLY

49. 49 WI – PFCS Cleaning of Utensils Work Instruction : Record(s) : Sanitation Checklist All Food Contact Surfaces (FCS) are kept clean at all times GMP Policy : SSOP : SSOP FCS-001 Cleaning of FCS Example :

50. KSC 1. SAFETY OF WATER SUPPPLY All water & ice used in the plant should be POTABLE Potable - clear, free from debris, and must meet microbiological standards for aerobic plate count, coliforms and E.coli QA Water Test Result Engineering and Maintenance Pipe layout Maintenance of pipes and water tank 50

51. KSC 1. SAFETY OF WATER SUPPPLY Human Resource Company policy (maintain sanitary condition inside company premises) Regulatory Requirement License from 3 rd party water service provider 51

52. KSC 2. Condition and Cleanliness of Food Contact Surfaces (FCS) Clean and Maintain all Food Contact Surfaces (Equipment, Work Surfaces, Utensils) Production Cleaning Program (Checklist & WI) Engineering & Maintenance Maintenance Program (Checklist & WI ) List of FCS 52

53. KSC 2. Condition and Cleanliness of Food Contact Surfaces (FCS) Internal Audit Spot checking Internal Audit Program Internal Audit Reports Technical Services Swab Test Results In-line inspection Test result 53

54. KSC 3. Prevention of Cross Contamination Prevent contamination through: Cleaning of processing area, wearing proper attire, separation of food items from non-food Production Prescribed Personnel Attire Cleaning Program Procedure for processing food grade items Safety Provision for Covid-19 control Images and signage 54

55. KSC 3. Prevention of Cross Contamination WH & Logistics Storage of raw materials (Food & Non-food) Storage of Finished goods Good warehousing practices Purchasing Requisition of MSDS/Food Safety Certificate Technical Services Migration Test Result MSDS Internal Audit Internal Audit Program Internal Audit Reports Engineering Facilities Maintenance (Checklist) 55

56. KSC 4. Maintenance of hand washing, hand sanitizing, and toilet facilities Sanitary facilities available for use by personnel. Cleaning and maintenance of facilities and adequate supplies at each station Production Cleaning and Maintenance Program Engineering Facilities Checklist Facilities Layout Safety Images and signage 56

57. KSC 4. Maintenance of hand washing, hand sanitizing, and toilet facilities Technical Services Swab Test Result Internal Audit Internal Audit Program Internal Audit Reports Purchasing Purchase orders for supplies 57

58. KSC 5. Protection of Packaging and Food Contact Surfaces from Contamination Protection of packaging from biological, chemical, and physical contaminants Production Cleaning and Maintenance Program WH & Logistics Storage area for packaging materials Purchasing Supplier Accreditation Program List of Approved RMs for Food Application 58

59. KSC 5. Protection of Packaging and Food Contact Surfaces from Contamination Technical Services In-line Inspection Form Swab Test Result Internal Audit Spot checking Internal Audit Program Internal Audit Reports 59

60. KSC 6. Labeling, Use & Storage of Chemicals/Toxic Compounds All chemicals used must be approved for use, labeled and stored properly Production Access Control Labels on containers Disposal of empty containers Cleaning and Maintenance Program Safety Images and signages PPEs (Policy & Procedure) 60

61. KSC 6. Labeling, Use & Storage of Chemicals/Toxic Compounds WH & Logistics Storage area for toxic chemicals Human Resource Training of Personnel Technical Services MSDS COA Purchasing Supplier Accreditation Program List of Approved chemicals Internal Audit Internal Audit Program Internal Audit Reports 61

62. KSC 7. Employee Health Condition Should Not Contaminate Food Do not allow persons who appear to have an illness, wound or other affliction to handle food Production Prescribed Personnel Attire Cleaning Program Procedure for processing food grade items WH & Logistics Storage of raw materials Procedure (Food & Non-food) 62

63. KSC 7. Employee Health Condition Should Not Contaminate Food Safety Provision for Covid-19 control Images and signage Health Condition Monitoring Fit to work Assessment Internal Audit Internal Audit Program Internal Audit Reports Human Resource Annual PE Pre-employment Requirements 63

64. KSC 8. Exclusion of Pests Prevention of pests from entering the plant Human Resource Training regarding pest control Policy Safety Pest Control Program Disinfection Checklist Logistics Pre-Loading Inspection Checklist 64

65. KSC 8. Exclusion of Pests Production Cleaning and Maintenance Program Waste Disposal (CENRO) Regulatory License from 3 rd Party Pest Control Provider Internal Audit Internal Audit Program Internal Audit Reports 65

66. KSC 9. Monitoring System for Cleaning & Personnel Hygiene Monitoring of cleaning, sanitation & hygiene programs to ensure compliance with the standard Production Prescribed Personnel Attire Cleaning Program Procedure for processing food grade items Safety Provision for Covid-19 control Images and signages Health condition monitoring 66

67. KSC 9. Monitoring System for Cleaning & Personnel Hygiene Engineering Inspection and maintenance of Sanitary facilities (Plan and Checklist) Human Resource Training and refresher course regarding importance of hygienic practices Internal Audit Internal Audit Program Internal Audit Reports 67

68. KSC 10. Glass, Metal and Hard Plastic Control Monitoring System for monitoring & control to ensure that glass, metal, hard plastic and other foreign Production Access Guidelines Cleaning and Maintenance Program Safety Images and signage WH & Logistics Control of Incoming RM Technical Services In-line Inspection Form 68

69. KSC 10. Glass, Metal and Hard Plastic Control Monitoring Internal Audit Internal Audit Program Internal Audit Reports DIC Glass Policy 69

70. 70 Thank you!