ISO 22000 - Control of Documents and Records

March 18, 2019 | Author: Chinnu Trinadh | Category: Records Management, Quality Assurance, Production And Manufacturing, Teknologi, Business
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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

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