VIRGINIA FOOD, INC.

ULTIMATE FOOD
SOLUTION

Good Documentation
Practices Training
MFG-FST-MDL-02
Revision No. 00
Revision Date: N/A
 1. Turn off your audio.

2. You may ask questions

anytime during the discussion.

3. Kindly participate.

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 WHAT ARE YOUR
Lorem ipsum dolor sit amet, consectetur adipiscing elit.
EXPECTATIONS?
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 Training Objectives
At the end of the 3-hour session, participants will be able to:

1. Discuss the importance of Good Documentation Practices in

ensuring high quality of work.

2. Apply different Good Documentation Practices in each

Department regardless of the differences of work
description.

3. Apply appropriate document control procedures.

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 “Importance of Good
Documentation
Practices
”

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 During An INSPECTION. . .

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Documented evidence was
requested. . .

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You immediately went to your
office. . .

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Entering the office door. . .

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You see this. . .

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You did not give up looking for
that document. . .

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Until for that moment, you have found what you have been looking for. . .

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When you go back, the office was empty. . .

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You have done everything to find the document but you found out that it
was useless. . .
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A glimpse of hope has appeared when the auditor called you, and you were
asked to submit the document tonight. . .

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You immediately scan the document with a smile. . .

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That glimpse of hope started to disappear when the scanner did not
function well. . .

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You decided to call the IT Department for immediate action. . .

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However, the personnel has a hard time reading the equipment manual due
to. . .
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This is because the manual is translated
to Chinese. . .

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You decided to use the traditional way
of fixing it. . .

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Luckily, it works!

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When the file has been sent, the team rejoices. . .

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A email was then received and the auditor replied immediately. . .

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the document you submitted has been rejected. . .

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It makes you sad and you are wondering why. . .

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You review the document Until you have realized that there is something
wrong with it. . .
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That it was not
signed. . .

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What did you learn
about the story?

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 What is
Documentation?

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Documentation

Many of you have responded with

“I wrote it down, therefore it is

documented”

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Documentation

However. . .
Documentation is not the single action of writing
down everything you do.

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Documentation

It is a multi-step process that includes the recording

of data, issuance, review, approval, presentation and
disposal of documents, and the ability to retrieve
documents.

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Documentation

Remember. . .
“The purpose of documentation is to create a
record of facts that proves procedures and
processes were correctly executed, thereby
substantiating the resulting data.”

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Documentation

The short version of this description and has always been

said in every industry that,

“if it is not documented, it

did not happen”

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 What is Good
Documentation
Practices?

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Good Documentation Practices (GDP)

These are methods for recording, correcting and

managing data, documents and records, to ensure
the reliability and integrity of information and data
throughout all aspects of a product’s lifecycle.

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But how it differs
to data integrity?

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Data Integrity

US FDA Defines data integrity as:

“The completeness, consistency, and accuracy of

data. Complete, consistent, and accurate data should
be attributable, legible, contemporaneously
recorded, original or a true copy, and accurate.”

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Data Integrity

This is also known as:

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principles of data integrity

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GDP and Data Integrity

Good Documentation Practices and Data Integrity

(GDP/DI) are inseparable elements of data
management, the foundation of any quality
system and are applicable to all departments.

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GDP and Data Integrity

While it is possible to have GDP without

data integrity, data integrity without GDP
is not possible.

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GDP and Data Integrity

GDP/DI are not only important regulatory

requirements, but they are also important business
requirements.

Solid GDP/DI improves risk management by virtue

of supplying more information.

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GDP and Data Integrity

It improves resource optimization by creating a

record of what worked and what didn’t work, and
what it took to make it work, such as costs and lead
times on components and materials.

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GDP and Data Integrity

GDP/DI also provides key information for critical

decisions and Recipe/Formulation transfer.

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GDP and Data Integrity

GDP/DI also protects against employee turnover.

When a lead Food Technologist leaves a company,
his/her research remains behind, but it if it is
unclear or incomplete it is no simple matter to
interpret or recreate it.

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GDP and Data Integrity

Establishing a policy of required GDP/DI for all

employees from the outset is cheap insurance for the
future of your projects.

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What is the difference between
document and records?

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Document Versus Records

Documents communicate information about how

to perform an activity.

They tend to be considered living, in that they must

be updated and maintained.

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Document Versus Records

Examples:

 Policies
 Standard Operating Procedures (SOP)
 Process maps
 Work instructions
 Blank forms

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Document Versus Records

Records are permanent, static evidence of results

achieved or activities performed.

Perhaps the most important difference is that

records cannot be changed.

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Document Versus Records

Examples:

 Completed forms
 Proficiency testing results
 Validations
 Verifications
 Assessments

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When discussing document and record keeping, it is easy to overlook the important
distinctions that exist between terms used to describe various documents.

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Document and Record Hierarchy

Policies
Processes
Procedures
Work Instructions
Forms
Records
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Document and Records

Policy - is a written statement of overall intentions

and directions that directs the plans and activities.

Process - is a set of interrelated activities that

transforms inputs into outputs.

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Document and Records

Procedure - is a set of specified, stepwise

instructions to carry out an activity or process.

It can be further classified as:

 Technical
 Non-technical
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Document and Records

Work Instructions - are abbreviated

instructions for use at the location where an activity
will be carried out, such as at a workbench.

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Document and Records

Other type:
Memo - can be considered a controlled document
that contains temporary policy, process, or
procedure information.

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Document and Records

Memos can have an expiration of 30 days unless

otherwise indicated and allow quick, document-
controlled communication to staff.

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Document and Records

Governing these documents requires a

“Master List”

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Document and Records

A document master list - provides a means for the

Department to track information about each
document, including its unique identification
number, name, version number, effective dates,
author(s), reviewers, due date for next periodic
review, and locations of any printed copies.

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 “General
Requirements
”

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 General Requirements 1

Controlled documents shall

have a unique identification
AAA – BBB – CCC - XX number and a version
number.
Where;

AAA – Division initials (e.g. mfg stands for

manufacturing)
BBB – Section / Team / Department
CCC – Type of Document
XX – Control Number
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General Requirements 1
No. Scope Abbreviation Stands for

1 MFG Manufacturing

2 FNE Finance
Division
3 HRA Human Resource and Admin

4 SAM Sales and Marketing

5 FSIA Food Safety Internal Audit Team

6 FST Food Safety Team

7 QAD Quality Assurance Department

8 RND Research and Development

Department / Section / Team
9 OPM Office of the Plant Manager

10 SPC Sanitation and Pest Control

11 ESD Engineering Services Department

12 BRSD Boiler and Refrigeration Services Department

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General Requirements 1
No. Scope Abbreviation Stands for

13 FIP Food Ingredient Preparation

14 MMP Meat Material Preparation

15 EXP Kitchen Expansion

16 EML Emulsion Line

17 KIT Kitchen

18 Department / Section / Team PAK Packaging

19 BST Blast

20 BRS Boiler and Refrigeration Services Department

21 HRD Human Resources Department

22 SPW Spare Parts Warehouse

23 LOG Logistics

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General Requirements 1
No. Scope Abbreviation Stands for

24 CAN Cannery

25 DIM DIMSUM

26 GSD General Service Department

27 PCS Pollution Control and Safety

28 NMC Non-Meat Warehouses

29 Department / Section / Team MIC Raw Meat Warehouses

30 TDD Transport and distribution Department

31 SLE Sales Department

32 MRK Marketing Department

33 PUR Purchasing Department

34 ACT Accounting

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General Requirements 1
No. Scope Abbreviation Stands for

35 CLC Clinic
Department / Section / Team
36 SEC Security

37 SOP SOP

38 MNL Manual

39 FORM FORM

40 RPT Report

41 Type of Document GEG General Guidelines

42 MOM Minutes of the Meeting

43 MEMO Memorandum of Agreement

44 MTR Master’s List

45 PLAN Plan

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General Requirements 1

Controlled documents shall

For Version Number; have a unique identification
number and a version
number.
It could be the following:

Option A: Version No. XX

Option B: Revision No. XX

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General Requirements 1

Controlled documents shall

have a unique identification
Example for ppt: number and a version
number.

MFG-FST-MDL-02
Revision No. 00
Revision Date: N/A
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General Requirements 2

All documents/records shall

have page numbers.

Page X of Y

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General Requirements 3

All master documents shall

be typed or preprinted.

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General Requirements 4

Instruction documents shall

have the effective date
Effectivity date – The date on printed, hand written or
stamped on them.
which an instruction becomes
valid.

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General Requirements 5

The date shall be in an

alphanumeric format.

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General Requirements 6

All documentation of time

and verification of time and
Slave clock system date shall be performed using
a consistent source.

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General Requirements 6

Slave clock system This includes time generated

from all Equipment and
computers used for activities.

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General Requirements 6

Gentle reminder

“Verify the time from the company clock provided in

the area where the activity is being performed and
not from personal watches.”

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General Requirements 7

For all the records change the date after

24 hours cycle daily, i.e. after 23:59 or
00:00 in the night as per the Philippine
Standard Time (GMT +8)

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General Requirements 7

Write time numerically in the form of

HH:MM in the document using the
military format (i.e. 24 hours cycle)
daily.

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General Requirements 8

If for some process, the observed time Time duration to be written as

follow:
duration is 2 minutes and 30 seconds
then it should be written as:

2 min. 30 sec.
2:30 min.

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General Requirements 9

In case time is printed from a

machine or a computer, the time
format of the machine or the
computer shall be followed.

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General Requirements 10

Attachments shall be cross-referenced

Example: to the parent document and the parent
document shall be cross-referenced to
the attachments.
 See attachment 1
 Refer to attachment 2
 Attachment 1 to ECAR-QAD-2021-
01
 Attachment 2 to Reference
Number 2021-05
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General Requirements 11

Example: In the case of electronic records, all

records of a parent document shall
indicate the relationship with the parent
 Electronic Record Title with Reference document.
no. 55 to ECAR-QAD-2021-01

 Water Test Result with reference no.

WAT-2021-01 As reference no. 2 to
MFG-QAD-SOP-01

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General Requirements 12

Data shall be recorded directly on approved

and authorized formats only (e.g.,
manufacturing records, laboratory logs, raw
data sheets, financial statements, etc.)

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General Requirements 13

Data for documentation shall

not be recorded on
unauthorized documents.

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General Requirements 14

Use of ditto marks (“) or down

arrows (↓) to fill in repetitive
entries are not allowed.

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General Requirements 14

Use of ditto marks (“) or down

arrows (↓) to fill in repetitive
entries are not allowed.

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General Requirements 15

Use of pencil or any

removable/water-soluble ink is
not allowed.

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General Requirements 16

Use of eraser or ink remover is

not allowed.

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General Requirements 17

Use of “white-out or correction

fluid” to cover recording then
write over it is not allowed.

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General Requirements 18

When a correction is necessary, the

erroneous/wrong entry shall be crossed out
with a single horizontal line such that it shall
not obscure the original entry.

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General Requirements 18

Remember:
“If this change affects the outcome of data, an investigation shall be initiated
and post-investigation, correction of the error shall be made and the change
shall be countersigned by a supervisor.”

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General Requirements 18

The following conditions that may occur during correction of

errors/completion of missed entries shall require evaluation as per the
investigation:

1. The employee who made the error/person who missed recording data is
not available in the organization.

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General Requirements 18

2. The information for an error/missed entry cannot be traced or

determined.

3. Errors/missed entries identified after a document/record has been

approved/closed by QA.

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General Requirements 18

4. The requirement for correction of errors, including

transcription/typographical errors related to data/missed entries in
documents/records, has already been submitted to regulatory agencies.

5. Errors identified in approved documents while the activity is being

performed.

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General Requirements 18

Reminder:

“Attempts to cover up mistakes are serious data integrity

concerns and are strictly prohibited at all levels.”

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General Requirements 19

All error corrections/filling of missed entries

shall be done by the document “doer”,
irrespective of the time/date at which the
error was noticed.

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General Requirements 20
If a worker (the “Doer”) made an error/missed an entry and they are no longer available due to reasons, such as leaving
the organization or taking a leave for an extended period, such matters shall be escalated to the department head and
an investigation shall be initiated.

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General Requirements 20

Based on the impact assessment and investigation outcome, another employee

may be authorized to correct the error/fill in the missed entry as part of the
corrective action.

The employee shall provide adequate justification and mention the name of the
doer while performing the correction.

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General Requirements 21

“Not all missed entries can be filled (corrected); if the information for filling in
the missing data cannot be traced or determined, the functional manager or
designee and QA Manager shall be informed immediately and shall take steps
for further actions (including a decision for not filling in the missing entry)
and provide explanations, which shall be recorded.”

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General Requirements 21

A. The corrections/explanations shall be countersigned by the QA Manager

or designee.

B. An investigation shall be completed and used by QA to determine the

disposition of the impacted products.

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General Requirements 22

Use of a stamp to replace manual dating or

signature on documents, except in the case
of validated electronic signature is not
allowed.

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S O L U T I O N
 General Requirements 23

When one (1) option is to be selected from

several text options, the correct option shall
be preferably marked with “√”.
Example:

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General Requirements 24

Do not leave blank space in any

record.

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General Requirements 24

Example: Blank spaces or pages shall have a

single line diagonally through
them with a signature and date.

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General Requirements 25
Errors/missed entries identified at the time of verification/review/approval of a document/record may be managed at
the level of verifier/reviewer/approver, as applicable; that is, the doer may correct the erroneous entry/fill in the missed
entry and mark it “Error Corrected”/”Late Entry” (as applicable) and sign (with current date) in the presence of the
verifier/reviewer/approver, as applicable.

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General Requirements 26

Errors/missed entries identified after a document has been approved/closed by QA shall be corrected/filled in (as
applicable) by the doer only in the presence of QA and QA shall counter-sign near the correction.

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General Requirements 27
Typographical errors/missed entries observed in “approved” documents during activity, shall be corrected/filled in (as
applicable) on the respective page by the concerned supervisor, including signature and date and shall be verified by the
QA Manager/designee.

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General Requirements 28

Documented information shall

provide a clear, accurate history of
an activity or event.

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General Requirements 29

Only current approved versions of

SOPs or forms shall be used to
perform activities.

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General Requirements 30

Systems shall be in place to prevent

the use of superseded documents.

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General Requirements 31

Uncontrolled documents shall not

be used in any activity especially in
the manufacturing areas.

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General Requirements 32

Email from non-validated or

unsecured systems should not be
used as a primary document where
a hardcopy is required.

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General Requirements 32

Email from non-validated or

unsecured systems should not be
used as a primary document where
a hardcopy is required.

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S O L U T I O N
General Requirements 32

Important Notice:

“When there is no alternative, the responsible person should print out the
email, sign, and date as being received.”

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General Requirements 33

Documents in PDF (or other image

formats) sent as an attachment to an
email can be used for activities but
must be signed/dated to do so.

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General Requirements 33

Note:

“it shall be signed/dated by the recipient upon

receipt.”

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General Requirements 34

Original records or master documents

shall be stored and archived in a
secured designated location.

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General Requirements 35

Copies of master documents/raw data

shall not be allowed unless justified.

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General Requirements 35

Remember:

“When copies of master documents/raw data are required, for

example during a regulatory inspection, they should not be
identified as an “UNCONTROLLED COPY”.”

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General Requirements 36

Use of scrap paper, post-it notes, or

loose (unbound) paper in
manufacturing areas to record data is
not permitted.

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General Requirements 37
When printouts are made that require verification (e.g. proof of weight printout and are not automatically verified by a
validated electronic system, they shall sign/dated manually by personnel performing the work (doer) and the person
verifying the work, as required.

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General Requirements 38

Reviews to ensure documentation is

complete and accurate shall be performed
by a qualified individual who did not
perform the task.

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General Requirements 39

Only validated Excel

spreadsheets shall be used for
calculations.

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 General Requirements 39

Reminder:
Note: Wherever such Excel spreadsheets are not available, calculations shall be re-
verified with qualified calculators.

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 “Signature
Practices”

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S O L U T I O N
Signature Practices 1

HR shall maintain an updated master

signature log wherein each employee
involved in activities shall provide their
signatures and initials.

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Signature Practices 1

Remember:

“Use the log for traceability of signatures for records as per

SOP Recording of Specimen Signatures of Employees.”

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 Signature Practices 2

Signatures for all activities shall always be

accompanied by the relevant date wherever
a separate date column has not been
provided.

Note:
“Signatures indicate that the Signatory is responsible for the
accuracy of data and information for the activity being
signed for.
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Signature Practices 2

Persons preparing, reviewing, or approving documents or persons recording,

verifying, or approving records shall sign and write the current date in the
documents.

Note 1:

“Current date refers to the date when the document/record is signed.”

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Signature Practices 2

Note 2:

“Entries in the documents/records along with signature and date shall be

made at the time when the activity is performed (contemporaneously).”

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Signature Practices 3

The signatory shall confirm the accuracy

and completeness of information and data
before signing.

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S O L U T I O N
Signature Practices 4

For each activity/document (as applicable),

each person shall sign (with current date)
either as a doer or a verifier (also called
“Checker”) or a reviewer or an approver.

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 Signature Practices 4

Remember:

1. One person shall not sign for multiple roles for the same activity or entry (e.g. a
doer cannot be the “Verifier”/”reviewer”/”approver” for the same activity or entry
recorded).

2. No employee is authorized to sign for an activity performed by another employee.

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S O L U T I O N
Signature Practices 5

A clear meaning of each signature shall be

provided (e.g. “Performed by”/”Verified
by”/”Reviewed by”/”Approved by”).

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 Signature Practices 5

Remember:
1. The doer shall check the result for its compliance against the specified
limits/acceptance criteria and is expected to inform the respective leadman/section
head/supervisor/officer/manager in case the results do not comply.
Note: The signature of the “Doer” denotes that the “doer” has performed the
activity and confirms the authenticity of the data as that of the activity performed.

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 Signature Practices 5

Remember:
2. The “verifier”/”checker” shall record and sign concurrently for the ongoing activity
being checked.
Note: The signature of the “verifier” denotes that the verifier has confirmed that the
entries are made correctly and are complying with predefined
specifications/acceptance criteria.

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 Signature Practices 5

Remember:
3. The “reviewer” shall review and sign (with date) for the activity/document/record
being reviewed; the reviewer may or may not be present when the activity is being
performed.
4. The “reviewer” shall review the completeness of the document/record and
conformance of results recorded during the activity to established process
parameters, limits, and other applicable standards that define the requirements of
the activity being performed.

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S O L U T I O N
 Signature Practices 5

Remember:
Note 1: The signature of the “reviewer” denotes that the document/record has been
examined, all requirements have been fulfilled and the document/record
demonstrates that the process was followed following the instructions provided.

Note 2: Reviewers/approvers may delegate authority to another suitably qualified

person to review/approve records, as applicable.

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 Signature Practices 5

Remember:
Note 3: The designee shall be qualified to perform the delegated task based upon
relative job position, training, experience, and subject matter expertise.

Note 4: Though a designee may perform the delegated task (of

reviewing/approving, as applicable), final accountability of the activity performed
by the designee shall reside with the person delegating the task.

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S O L U T I O N
 Signature Practices 5

Remember:
Note 5: Supervisors of the signatory and/or members of the same department at an
equivalent or higher position may function as designees without prior delegation of
authority.

Note 6: Signing someone else’s name unless the signer is a designee is strictly
prohibited.

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S O L U T I O N
Signature Practices 6

Pre-dating or post-dating
(backdating) either documents or
corrections are strictly prohibited.

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S O L U T I O N
 Signature Practices 6

Reminder:

Note 1: Pre-dating is completing an activity and then signing/dating that the activity was
performed at a later time/date.

Note 2: Back-dating is completing an activity and then signing/dating that the activity
was performed at an earlier time/date.

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 “Electronic Records”

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O R G A N I C S C O M P A N Y
S O L U T I O N
 Electronic Records

Systems shall be designed to assure compliance and data integrity including but not
limited to:

1. Restricting control/access to templates used for recording date;

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S O L U T I O N
 Electronic Records

2. Implementing user access rights that prevent amendments to data or audit trail
information;

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S O L U T I O N
 Electronic Records

3. Ensuring access to raw data for staff performing data checking activities;

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O R G A N I C S C O M P A N Y
S O L U T I O N
 Electronic Records

4. Locating printers near associated activities;

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O R G A N I C S C O M P A N Y
S O L U T I O N
 Electronic Records

6. Using clocks for recording timed events;

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S O L U T I O N
 “Organizing
Electronic Records”

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O R G A N I C S C O M P A N Y
S O L U T I O N
Organizing Electronic Records 1

Centrally locate records in

share drives

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 Organizing Electronic Records 1

Note 1: Determine ahead of time who should have permission to access, view, edit, or
delete files and folders within a shared drive.

Note 2: If there are security concerns for documents that specifically assigned to a staff
position or team, your it team should be able to help you set up restricted areas on a
share drive that are only accessible to designated parties.

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 Organizing Electronic Records 1

Note 3: In some unique cases, it may be determined that some records should remain on
a personal drive but isolated and clearly labeled so they can easily be located and
identified after the individual leaves their position.

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 Organizing Electronic Records 2

Do not store records on your

computer’s hard drive or
personal drive

Note: Records should never be stored on your computer’s C:

drive (hard drive). This drive is rarely, if ever, backed up by
normal IT processes and records will be lost should your
computer fail.

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Organizing Electronic Records 2

Do not store records on your

computer’s hard drive or
personal drive

Note: records stored on personal drives are inaccessible to

other employees and have an increased chance of being lost
when the employee leaves their position.
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Organizing Electronic Records 3

Use a hierarchical
folder structure

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S O L U T I O N
 Organizing Electronic Records 3

Note 1: Integrating an RDA number into folder names may help your organization
manage records over time and will help provide some rules for the folder content should
the records ever be integrated into a content management system.

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 Organizing Electronic Records 3

Note 2: Use subfolders to further organize your files, but try to keep structure flattened
as much as possible.

Reason: Long file name/file paths can cause errors when transferring files and folders to
other locations. Traditional Windows systems recommend that file path lengths be kept
below 260 characters – however it will allow for longer which often renders the file
inaccessible.

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Organizing Electronic Records 4

Separate
supplemental
materials

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S O L U T I O N
 Organizing Electronic Records 3

Note: Generally, these are kept for convenience or reference and should be discarded
when no longer needed. Storing and tagging these in a separate subfolder will help in
disposing of them at the appropriate time.

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Organizing Electronic Records 5

Do not save more than one

copy of a record

Note: Unless there is a valid business reason for

keeping multiple copies of something

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 Organizing Electronic Records 6

It may be necessary to keep significant versions of important

organizational documents which significantly change an Versions and drafts of
documents
organization’s procedure or policy, in which case you should
review with your Document controller.

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 Organizing Electronic Records 6

Note 1: For the vast majority of documents however, only the final version needs to be
kept and then rest can be deleted once the final version is complete.

Note 2: Where multiple versions are deemed to be important, they should be clearly
labeled to eliminate any confusion as to which is the final item of record.

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 “Managing Electronic
Mail”

Creation and
Transmission
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O R G A N I C S C O M P A N Y
S O L U T I O N
 Creation and Transmission 1

“Before conducting business using email, assess the Making determinations

business needs of the department and the type of about the use of email
within your Department.
information to be communicated to determine
whether email is the most suitable method of
communicating the information.”

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 Creation and Transmission 2

“A complete email record must incorporate the address,

identify the intended recipient(s), and the message content. Components of a complete
email record
The message should consist of: identification of the sender,
meaningful subject line, and signature block.”

Note: if a record copy of an email message is printed, all

components need to be printed to have a complete record.

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 Creation and Transmission 3

Note 1: Keep email free of personal opinions and

Impact of copying and
inappropriate commentary. forwarding function

Note 2: Never create a message that you would not

want to appear on television or in the newspaper.

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 Creation and Transmission 4

If you send to a "distribution list," you must also keep

a copy of the members of that list for as long as you Use of Distribution Lists.
are required to keep the message itself.

Reason: You might send the confidential information

to someone not included in the master list.

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 Creation and Transmission 5

“Attachments may be integrated directly into the

department/user's filing system, multiple attachments or Handling Attachments
attachments in multiple formats may be associated with an
individual message, or the body of the message itself may
contain information associated with the attachments.”

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S O L U T I O N
 Creation and Transmission 5
Note 1: If the electronic message is a record and contains attachments, the attachments must be
retained as part of the record. Retention should be defined by the longer of (1) the retention
requirements for the message or (2) the retention requirements for the attachment.

Note 2: If your office transmits attachments via email, when possible, consider placing the documents
on a shared drive or making them available across a local area network. This will ease the pressure on
the users who must manage the attachments, and on the email system's storage capacity.

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S O L U T I O N
 Creation and Transmission 6

Drafts should be purged immediately after the final version

has been approved. Handling Drafts

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S O L U T I O N
 Creation and Transmission 7

If the message and/or the attachment is edited and then

forwarded, the forwarding individual (rather than the Handling
Copies/Duplicates
message creator) is considered the official record copy owner
and responsible for the record's retention.

Note: All other copies of the message should be deleted as

soon as they are no longer needed by the recipient.

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 Creation and Transmission 8

After the last email message on the original topic is sent, the
individual responsible for maintaining the record copy shall Handling EMail Threads
file the thread according to content, not necessarily by subject
line.

Note: The date filed is the start trigger for the retention
period. All other participants in the message thread should
delete their copy as soon as it is no longer needed.

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S O L U T I O N
 Creation and Transmission 9

“Unless the email has been placed expressly in the public

domain or the use is fair use, the user must seek permission Copyright laws apply to
email
from the copyright holder to use his or her copyrighted work.”

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S O L U T I O N
Creation and Transmission 10

Transmission of
“Do NOT use email to Confidential and Sensitive
Information

communicate confidential or
sensitive records.”

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S O L U T I O N
 Creation and Transmission 11

“When creating records using email, follow standards you

would use in formal business communications, i.e. use Netiquette and
communication standards
standard business letter layout, business language, and
proper grammar and punctuation.

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S O L U T I O N
 “Managing Electronic
Mail”

Maintenance

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O R G A N I C S C O M P A N Y
S O L U T I O N
 Maintenance 1

1. Departments should create a filing system for email that Maintain a filing and
parallels related filing structures the office maintains for classification scheme that
will facilitate access,
hard copy files. retention and disposition.

2. Filing practices should separate personal messages so

they can be routinely deleted.

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S O L U T I O N
 Maintenance 1

3. Departments should also establish a department-wide Maintain a filing and

naming convention for electronic filing systems and classification scheme that
will facilitate access,
electronic records. retention and disposition.

4. Regularly delete non-record material.

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S O L U T I O N
Maintenance 2

Email that is a record must

“Envelope information consists of be maintained and
preserved with envelope
receipt and transmission data, information.

sender and recipients, date sent

and/or received.”

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S O L U T I O N
 “Managing Electronic
Mail”

Retention and
Disposition
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O R G A N I C S C O M P A N Y
S O L U T I O N
Retention and Dispostion 1

“Messages that are deemed to be There is NO single

retention period for email
records need to be retained the same messages.

length of time that they would be

retained if they were hard copy.”

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S O L U T I O N
 Retention and Disposition 2

1. If the record is to be maintained in an electronic format, Email records must be

it must be migrated to new software and storage media as maintained in a usable
format throughout the
upgrades occur. approved retention period.

2. If the email is printed out and retained in paper form, all

envelope information must be printed and retained with
the record.

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S O L U T I O N
Retention and Disposition 3

Email records should be

“Deleting records systematically and deleted promptly as soon
promptly limits risks in the retention of as the approved retention
period has expired.
records that are no longer needed and
significantly reduces space and cost
requirements to maintain the email.”

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S O L U T I O N
 Retention and Disposition 4

Approved retention times

“If the records continue to be maintained must also be applied to
on backups beyond the approved retention backups containing copies
of the email records.
time periods, the information still remains
accessible and subject to discovery and
open record requests.”

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S O L U T I O N
 “Managing Electronic
Mail”

Access

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 Access

“Close your email and lock you computer if you intend

Protect access to your email
to be away from your desk for periods of time and system
don't share your passwords.”

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 “Document Control
Procedure”

Approval and
Issuance
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 Approval and Issuance

1. Prior to the issue, the document owner and the direct head shall review and
approved controlled documents.

2. Revisions to existing documents are reviewed and approved by the same functions
that performed the original review and approval.

3. Digital formatting is the preferred method for maintaining quality system

documents.

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 Approval and Issuance

4. Computers shall be protected by the use of virus protection software, regular data
backups, and off-site storage when appropriate.

5. Printed work instructions that are made available at the point of use are controlled
by the document owner and unauthorized copies should not be made.

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 Approval and Issuance

6. Obsolete printed copies of internal documents retained for legal and/or knowledge
preservation shall be marked “OBSOLETE” and/or held in a binder/folder marked
“OBSOLETE”.

7. Superseded/Obsolete Documents are moved to a segregated location and made

inaccessible to prevent unintended use.

Note: The Quality Assurance Manager should be contacted for access to obsoleted
documents.

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 “Document Control
Procedure”

Control of Customer
Supplied Information

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 Control of Customer Supplied Information

Examples of customer-supplied information are blueprints, art files, sketches, samples,

purchase orders, and emailed correspondences.
1. A printed copy of a blueprint and any relevant customer-supplied information
should travel with quote requests and shop orders.
2. If the electronic file is later accessed to generate artwork or be reprinted, the contents
of the file should be checked to verify that it matches the customer’s current
requirements.

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 Control of Customer Supplied Information

3. the current revision for a blueprint or other customer-supplied information can be

verified by referencing a current purchase order, a customer’s supplier portal, or
checking with the customer’s purchasing or quality representative.
4. Obsolete blueprints and other customer-supplied information that is retained for
legal and/or knowledge preservation shall be marked “OBSOLETE” or held in a
binder/folder marked “OBSOLETE”.

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 “Document Control
Procedure”

Control of External
Documents

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 Control of External Documents

External documents are defined as documents whose origin and control is by a body
outside VFI.

Examples:

 Equipment manuals regarding the operation, safety, repair or maintenance of

equipment used by XXX in the processing of customer orders.

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 Control of External Documents

Examples:

 Supplier manuals, specifications, or standards from customers that are provided to

VFI, which contain customer requirements that are not part specific.

 Documents necessary for the planning and operation of the quality system.

 International Quality Standards, example: ISO 22000:2018.

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 Control of External Documents

1. External documents are maintained as digital files whenever possible.

Note: When practical, external documents that are readily available on the internet
should not be maintained at VFI.

2. Printed copies of obsolete, external documents that are retained for legal and/or
knowledge preservation shall be marked “OBSOLETE” and/or held in a
binder/folder marked “OBSOLETE”.

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 Control of External Documents

3. Electronic files of obsolete, external documents that are retained for legal and/or
knowledge preservation shall be overwritten with notes to indicate that the file is
obsolete.

Note: If the contents of the file are write-protected, the file name shall be appended
with “OBSOLETE”.

4. The personnel responsible for periodically verifying that VFI has access to the current
revision of an external document is identified in the External Document Master List.

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 Control of External Documents

Note: When appropriate, the schedule, method for verification, and other means for
control shall be recorded there as well.

4. The Customer Master List Database can be used to save files and URL links to
customer-specific external documents.

Note: External documents saved in the Customer Master List Database are
considered “For Reference Only”

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 “Document Control
Procedure”

Maintaining Quality
Records

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 Maintaining Quality Records

The table below identifies the type of quality records maintained at VFI and how each is
maintained.
Item Type of Record How it should be maintained?

1. Protect the record from becoming dirty of soiled.

1 Paper 2. Keep records away from sources of contamination.
3. Use a plastic sleeve if appropriate.

1. Use virus protection practices.

2 Electronic Media 2. Back up data on a regular basis.
3. Maintain back ups off-site if appropriate.

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 “Document Control
Procedure”

Retention
Requirements

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 Retention Requirements

retention requirements are specified in Document Master List with Revision History.
Specified retention requirements are established in accordance with the:

 Duration of the contract;

 Life of the product;
 Requirements of applicable standards;
 The government, customer and contractual requirements.

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 “Document Control
Procedure”

Archiving
Requirements

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 Archiving Requirements

Document controller uses the steps in the table below to properly archive records.

Step Task Action

1. Indicate the names of the records being archived.

1 Labeling the box 2. Indicate the period covered by the records being archived.
3. Indicate the date the box is being archived.

1. Place the records in a designated archive storage area that will:

2 Storing the box  Protect the record from becoming dirty or soiled.
 Keep records away from sources of contamination

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 Archiving Requirements

Disposition of original quality records Authorized personnel uses the steps in the table
below to assure the proper disposal of original quality records.

1. Review the records to be disposed of.

2. Ask: Has the useful life of the records ended?
If “No”, do not dispose of the records.
If “Yes”, go to Step 3.

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 Archiving Requirements

3. Ask: Have the contractual requirements of the records been satisfied?

If “No”, do not dispose of the records.
If “Yes”, go to Step 4.
4. Dispose of quality records. VFI Management determines disposal methods for
quality records based on the type of quality record, data contained in the record,
and/or security requirements. Records are shredded when appropriate.

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 “Archiving”

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 What are the different
document storage options?

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 Traditional Paper Storage

It’s when you archive your paper documents by

filing them away, or by paying an off-site secure
storage facility like Storage Vault to store them for
you.

It’s common practice for large businesses that

need to maintain a paper trail of non-mission-
critical documents.

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 Traditional Paper Storage
Here are your two main options in storing a paper-form:

1. In House Storage

For really important documents, you may want to consider purchasing a fireproof safe as this will
ensure that your paper documents can survive anything catastrophic happening to your premises.

If you choose to go with regular filing cabinets or other storage units, make sure they’re secure and
keep them organised with paper clips and separators.

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 Traditional Paper Storage
Here are your two main options in storing a paper-form:

2. Off-site storage

Using off-site storage facilities is a cost-effective solution as they offer excellent security and affordable
space.

When choosing a storage facility, consider the following:

a. How close the facility is to your workplace? Could you access your documents quickly in a pinch?

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 Traditional Paper Storage
When choosing a storage facility, consider the following:

b. Records management services. Depending on the documents you plan on storing, you may want
to choose a facility that offers services like indexing and file retrieval.

c. The shelving quality. Choose a facility that boxes records and holds them on metal shelves.
Storing them on the floor puts them at risk of water damage from spills

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 Traditional Paper Storage
When choosing a storage facility, consider the following:

d. Security and access. It goes without saying that you should make sure your chosen facility is
secure, with both internal and external cameras and properly-vetted employees.

e. Climate control. Some facilities use climate to control to guard against paper degradation.
Consider if you’ll need this feature and choose a facility accordingly.

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 Digital Storage

There are document archiving companies out there that will handle the whole process for you. They’ll
digitize your documents, give them back to you on USB drives or CDs, or back them up on the cloud.

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 Digital Storage

Note 1: The advantage of digital storage is that it saves a ton of space. You don’t need any physical
space to store your document—everything’s stored in cyberspace.

However, this isn’t for everyone. Many business owners like retaining physical copies and don’t like the
idea of trusting their entire document archiving system to a computer.

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 Traditional Paper Storage
There are a few different digital document storage solutions to choose from, such as:

 Use Windows libraries to store documents on your hard drive

 Store your documents in the cloud via a service like OneDrive or Google Drive
 Backup your documents to external storage hardware like removable hard drives
 Store documents using a specially-designed DMS
(DMS Example: Templafy, Docuware, Mastercontrol Document Control, M-Files, XaitPorter, etc.)

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 Scan on Demand Storage

It’s a solution in which a company will store

your paper documents for you off-site but
will also scan them and send you a digital
copy upon request.

This makes it a good option for businesses

that want to store a large amount of
documents off-site but may still occasionally
need to access them.

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 Scan on Demand Storage

However, scan on demand solutions are more expensive than ordinary paper storage as you’re paying
for an additional service.

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“We cannot become what
we want by Remaining
what we are”
-Max Depree

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 “Examination”

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 Examination

Kindly Access this link or QR Code using your smartphone or laptop with access to the
internet:

https://forms.office.com/r/RNjjPwyr1U

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 VIRGINIA FOOD, INC.
ULTIMATE FOOD
SOLUTION

Thank You