ISO 22000 - Control of Documents and Records
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Description
ISO 22000:2005 FOOD SAFETY MANAGEMENT SYSTEM
TOPICS: Control of Documents
Control of Records
FS02 - Control of Documents
To define the methods and responsibilities for controlling documents used to provide work direction or set policy; and to define methods for document creation, revision, approval, distribution, reproduction and destruction.
1. DOCUMENT FORMAT 2. DOCUMENT CREATION 3. TEMPORARY CHANGES TO DOCUMENTS 4. DOCUMENT REVISION/REPRODUCTION OF FSMS DOCUMENTS 5. DELETION OF FSMS DOCUMENTS 6. EXTERNAL DOCUMENTS VALIDATION 7. DOCUMENT DISTRIBUTION 8. DOCUMENT CONTROL PROCESS REVIEW 9. DOCUMENT NUMBERING SYSTEM
DOCUMENT NUMBERING SYSTEM –
Company or Plant code;
–
Quality System and prerequisite program code;
–
Department / Section Code;
–
Document type or category;
–
Number of document in the series for a particular document type.
FIRST SEGMENT: COMPANY / PLANT CODE
COMPANY / PLANT CODES SIPCO
Common documents and applicable to all plants (company-wide)
SIPCO1
Originating from or applicable to SIPCO 1
SIPCO2
Originating from or applicable to SIPCO 2
SIPCO3
Originating from or applicable to SIPCO 3
SECOND SEGMENT: MANAGEMENT SYSTEM AND PROGRAM CODE
MANAGEMENT SYSTEM CODE FS
Indicates that the document is part of the Food Safety Management System PREREQUISITE PROGRAM CODES
01
Statutory and Legislative Requirement
18
Hazard Analysis Preparation
02
Control of Documents
19
Production and Process Control
03
Control of Records
20
Hazard Analysis and Assessment of Control Measures
04 05
Management Responsibility Job Descriptions
21 22
Operational PRP Plan Management HACCP Plan Management
06
Internal and External Communication
23
HACCP Verification Planning
07 08
Emergency Preparedness and Response Competence, Awareness and Training
24 25
Identification, Labeling and Traceability Corrective Action
09
PRP: Visitors Access
26
Control of Non-Conforming Products
10 11
PRP: Personal Hygiene PRP: Cleaning and Sanitation
27 28
Consumer and Customer Complaints Product Recall
12
PRP: Pest Control
29
13 14
PRP: Premises PRP: Maintenance
30 31
Control of Monitoring and Measuring Internal Audit and System Validation
15
PRP: Foreign Object Control
32
Continuous Improvement
16
PRP: Control of Suppliers
33
Control Of Chemicals
17
PRP: Purchasing
Validation of Control Measures
THIRD SEGMENT: DEPARTMENT/SECTION CODE
DEPARTMENT / SECTION CODES MW
M & W Business Unit
PR
QC
Quality Control (Line)
ACE
QA
Quality Assurance
SC
Supply Chain Department
SR
Syrup Production
FG
Full Goods Warehousing
WT
Water Treatment Plant
RM
Raw Materials Warehousing
ML
Microbiological Laboratory
PA
Product Availability Section
RO
Reverse Osmosis Plant
MFG AQF
Manufacturing Department Aquafina Line
OED
Projects Section ACE Plant
Organizational Effectiveness Dept.
HR
Human Resource Department
CPS
Corporate Purchasing
CSD
CSD Line
SM
Sales and Marketing Department
TEC
Technical Department
FN
Finance Department
ME
Mechanical Section
IT
Information Technology
EL
Electrical Section
HSE
Health, Safety and Environment
UT
Utilities Section/Boiler/Compressor
MEM
MEM
FL
Fleet
CO2 AC
CO2 Plant / Manufacturing AC Workshop
FOURTH SEGMENT: DOCUMENT TYPE OR CATEGORY CODE
DOCUMENT TYPE / CATEGORY CODES GL
Guidelines
CK Checklist
PG
Program
PL
Plans
PO
Policy
JD
Job Description
PR
Standard Operating Procedure
EX
External Document
WI
Work Instruction
IN
Internal Document
JA
Job Aids
TO
Table of Organization, Org. Charts
LG
Log sheet
TA
Table
RG
Register, List, Inventory
DW
Drawings, Diagrams
IR
Inspection Report, Test Reports, Laboratory Reports of Analysis
FR
Forms
LT
Letter
FIFTH SEGMENT: DOCUMENT NUMBER SERIES IN THE CATEGORY
Pertains to the specific number of the document in the document category series .
Examples: Raw Materials: SIPCO2-FS19-RM-CK-01: Incoming Vehicle Inspection Checklist QA SIPCO2-FS19-QA-IR-01: Sugar Inspection Report Production: SIPCO2-FS19-PD-PR-01: Filler Standard Operating Procedure Syrup room: SIPCO2-FS19-QC-LG-02:Finished Syrup Analysis Mechanical: SIPCO2-FS14-ME-EX-01: SMI 1 Electrical: SIPCO2-FS14-EL-EX-01: KHS Line 1 Full Goods Warehouse SIPCO2-FS19-FG-PR-01: FIFO/FEFO Procedure
Examples: Cleaning and Sanitation: SIPCO2-FS11-FSM-PL-03: Master Cleaning and Sanitation Schedule SIPCO2-FS11-ML-WI-01: AC Grills Cleaning
Glass and Brittle Plastic Inspection SIPCO2-FS15-FSM-CK-01: GLASS AND BRITTLE PLASTIC INSPECTION CHECKLIST – (BLUE ZONE DAILY)
Document Structure –
–
All Procedures and Work Instructions have the document number, title, revision and page number in Page X of Y format in the footer of each page of the document. The document should contain, at a minimum, the following information on each document: •
Policy;
•
Purpose;
•
Scope;
•
Responsibilities;
•
Safety;
•
Procedures;
•
Reference;
•
Records; and
•
Revision History
TOPIC Control of Records
CONTROL OF RECORDS IMPORTANCE
• Systematic approach in records keeping which includes. - Records identification/Classification - Records generation - Records Filing, Retention, Maintenance & Disposal - Creation & Borrowing SCOPE:
- Applies to all records generated - handwritten, hardcopy and electronic (soft).
CONTROL OF RECORDS WHAT IS A RECORD? - Anything, such as a document or a photograph, providing permanent evidence of or information about past events. Requirement: - All records must be clear and legible, complete and adequate (no blank spaces left out, or NA is indicated if not applicable), actual data, on time, readily accessible traceable to process owner. - Written records should have proper reference number, completed in permanent ink (Blue) to help ensure legibility and to protect them from unauthorized change.
CONTROL OF RECORDS Requirement: - Changes or corrections to hardcopy records should be made with a single line through the incorrect entry, dated and initialed by the person making the change. Correction fluid or tape should not be used.
- All pages of records are numbered (for forms with more than 1 pages). - Traceable to the latest documented SOPs. - Electronic records of food safety management activity should be automatically generated and activity logs kept.
CONTROL OF RECORDS Records Retention: • In-Process Records – Records of the current year • Active Records – Records of the preceding year that have not yet met their minimum retention periods. They are stored in such a way that they are readily retrievable for quick reference in the operation. • Inactive Records – Records that have reached their minimum retention period and are being kept in archive. Archived records are retrievable but not necessarily readily retrievable. • Lifetime Records – Records that are perpetually kept for future reference. They usually consist of guidelines, statutory and legal records, certificates, memorandums that define policies, special studies. • Obsolete Records – Records past their MRP determined to be already irrelevant to the operation and are for disposal through shredding or other prescribed means.
CONTROL OF RECORD Records Maintenance: •
•
•
Supervisor or Record Custodian shall ensure that records are maintained in a suitable environment that prevents damage or deterioration and also prevents loss of records. – The methods used to prevent loss of hardcopy records may include controlling access, use of checkout cards, or auditing of records as appropriate for the particular record. – Electronic records are protected from damage, deterioration, loss, or unauthorized change by use of appropriate access control methods. Unless otherwise indicated, records are disposed after their minimum retention time is attained, as indicated on SIPCO-FS03-FSM-RG-01: FOOD SAFETY RECORDS LIST. METHOD OF DISPOSAL: SHREDDING In the intent of records disposal, every department shall generate a disposal turnover list which has to be endorsed to the document controller.
CONTROL OF RECORD RECORD CHARGE OUT PROCEDURE • •
•
•
•
For proper accounting and to prevent loss of records, borrowing of records or record’s file must follow an effective charge-out system. Anyone wishing to borrow a particular record or records file must make his request through the Supervisor and shall accomplish SIPCO-FS03-FSM-FR01: RECORDS CHARGE-OUT CARD. If the records need not be brought out of the room, Records Charge-Out Card is not needed. The Records Charge-out Card must indicate the details of the records being borrowed and the expected date of return. The loan-out transaction can be renewed or extended as needed by updating the Records ChargeOut Card. Supervisor or his designate shall follow-up return of the records as indicated in the Records Charge-Out Card and send advise to borrower when return of records is due or he may advise extension of the loan-out transaction. Returned records shall be put back to its designated file location and the Records Charge-Out Card is updated accordingly to acknowledge return
RECORD KEEPING GUIDELINE I. Enroll Documents/Records 1. Department Master Document List (SIPCO-FS02-FSM-RG-03) - will contain Procedures, Work Instructions, Policies, Guidelines, External Documents ( Manuals, etc.) 2. Department Records List (SIPCO-FS03-FSM-RG-02) - will contain Log Sheet, Checklist, Forms, Plans, Inspection report. - Records Retention Code (RRS) will be assigned to this records II. Label folder and attached sticker label to it. III. File records accordingly IV. Records Access Control shall be in place - implement “Record Charge Out Card” (SIPCO-FS03-FSM-FR-01) IV. Turn Over Records for due for Disposal - Accomplish Turn Over List & Disposal Author (SIPCO-FS03-FSM-FR-02)
RRS CODE PER DEPARTMENT
DEPARTMENT / SECTION CODES MW
M & W Business Unit
PR
QC
Quality Control (Line)
ACE
QA
Quality Assurance
SC
Supply Chain Department
SR
Syrup Production
FG
Full Goods Warehousing
WT
Water Treatment Plant
RM
Raw Materials Warehousing
ML
Microbiological Laboratory
PA
Product Availability Section
MFG
Manufacturing Department
OED
AQF
Aquafina Line
Projects Section ACE Plant
HR
Organizational Effectiveness Business Unit Human Resource Department
CSD
CSD Line
CPS
Corporate Purchasing
TEC
Technical Department
SD
ME
Mechanical Section
FN
Sales and Distribution Business Unit Finance Business Unit
EL
Electrical Section
IT
Information Technology
UT
Utilities Section
CO2
CO2 Plant / Manufacturing
OHS/HSE Occupational Health and Safety MEM
Fleet / MEM
SIPCO-FS02-FSM-RG-03 : DEPARTMENT MASTER DOCUMENT LIST
SIPCO-FS03-FSM-RG-02 : DEPARTMENT RECORDS LIST
FILE FOLDER LABELING SECTION RECORD COLOR CODE SIPCO2 M&W Quality Control
Division
Blue
Manufacturing (Mfg)
Orange
Quality Control (QC)
Department Section
QC - 01 SIPCO2-FS11-QC-WI-01 Cleaning & Sanitation Work Instruction
Records Retention Code Record Code Records Description
SIPCO2-FS11-FSM-CK-01 Cleaning & Sanitation Checklist
YEAR
: ________
VOLUME: ________
Pink
Syrup Room (SR)
Light Blue
Water Treatment (WT)
White
Quality Assurance/Micro (QA/ML)
Black
Utilities (UT)
Red
Period of Data Collection Refers to No. of Folder generated of the Same RRS Code Section Record Color Code
Electrical (EL)
Green
Mechanical (ME)
Yellow
CO2
Violet
Supply Chain ( RM)
Gray
Supply Chain ( Warehousing)
Light Green
AC Workshop (HVAC)
Dark Blue Maroon
Technical (TEC) Spare Parts Store
FILE FOLDER STICKER RECORD STICKER LABEL 1. DEPARTMENT DOCUMENTS (Lifetime Documents)
2. DEPARTMENT RECORDS (Records with Disposal Period)
DOC NO.
SIPCO2-FS14-EL-EX-01
RRS CODE
QC-01
IN-PROCESS
NOT APPLICABLE
IN-PROCESS
JAN – DEC 2011
ACTIVE
NOT APPLICABLE
INACTIVE
NOT APPLICABLE
DISPOSAL DATE
NOT APPLICABLE
METHOD OF DISPOSAL
NOT APPLICABLE
ACTIVE
JAN – DEC 2012
INACTIVE
JAN – DEC 2013
DISPOSAL DATE
JAN 2014
METHOD OF DISPOSAL
SHRED
SIPCO-FS03-FSM-FR-01: RECORD CHARGE OUT CARD
SIPCO-FS03-FSM-FR-02: TURN OVER LIST & DISPOSAL AUTHORIZATION
END
THANK YOU
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