CHANGE CONTROL

APPLICATION Plant/Company Name:

EXPORTS Jimmy Alexander Valero Warehouse Supervisor

Quality Management
Head

*Name of the Change: Modification of package assembly formats

DESCRIPTION OF THE CHANGE
*Current situation *Desired Situation (what do you want?
The documentation "formats" that are filled out in each of the OPs for Assembling Adjust the formats so that they apply to the package
Packages that are carried out in exports, contain activities typical of the processes assembly process activities being worked on and
carried out in the plant and that do not apply for exports, therefore blank or N
spaces must be left. /TO.

*JUSTIFICATION FOR CHANGE (why?)

The process of conditioning and assembly of packages that was previously carried out in the plant, is currently being carried out in the
documentation requested for these conditioning or assembly continues linked to the processes of conditioning and packaging of activities
that do not apply to the export area, having to leave blank spaces or "N/A", therefore tedious diligence and the waste of sheets is
considerable.

Regulatory
Catering Costs
compliance

*Root Cause (Primary cause that generates the need to produce or activate a change)
darization specification

*IMPACT OF CHANGE ON

Country Impact CPAC CDP Observations Regulatory Observations

Yea No Yeah No
Peru h x
Colombia x CO02 Documentation
maquiladoras x
Other CDPS x PR03
US03
IMPACT OF CHANGE ON OTHER PROCESSES
VALIDATIONS Impact Observations:

Yeah No
Cleaning Validation x
Process Validation x

Equipment Qualification x

OTHERS
Stability studies x

FM-01522 (10/17-
V11)
 x Implementation of new formats to PR-00728 "REVISION, EN
Documents / Specifications
Suppliers x

Material/Product Stock x

QA x

Manufacturing / Maquiladoras x
*PRELIMINARY EVALUATION ACTIVITIES FOR CHANGE
No. Activities Do
1 Change Control Creation

2 Meeting with the Change Control committee

3 Design and presentation of the formats for the challenge Le

e
4 Validation and approval of the following areas must be obtained: CPAC and CDP \
Quality, Exports and Document Management
5 Document Update \

II. COMMITTEE EVALUATION

*RELEVANT RISKS ASSOCIATED WITH THE IMPLEMENTATION OF CHANGE
(If you do not register the risks in this field, specify the tool you are using for risk identification)

Response No
No. Risk Strategies .

Observations:

*KEY ACTIONS FOR IMPLEMENTATION OF CHANGE AND ADDRESSING RISKS

(Space to fill in the Committee, include within the activities if it should be communicated to the regulatory
entities

Follow
Date Request
No. Action Responsible
Execution Fulfill
YES

FM-01522 (10/17-
V11)
 Hader Lopez /
1
Communicate to the areas or processes Jimmy Valero /
impacted by the change Cesar Cruz reu date

Hader Lopez /
2 Change Control Creation Jimmy Valero /
Cesar Cruz
11/23/2017

Hader Lopez /
Jimmy Valero /
3 Modification and Verification of procedures
Cesar Cruz /
Yorley Riveros

Hader Lopez /
Verification of Current Formats and Adjustment Jimmy Valero /
4
according to the needs of the process Cesar Cruz /
Yorley Riveros
Hader Lopez /
Jimmy Valero /
5 Change Control Closing
Cesar Cruz /
Edilma Moreno

"Take the record of the signatures of the committee members who approved the viability of the change and the
beginning of the implementation"

FM-01522 (10/17-
V11)
Members Post
Yorley Riveros Quality Management Assistant
Omar de Jesus Mejia Warehouse and Export Manager
Fernando Angel Head of Quality
Management
Edilma Moreno Warehouse Assistant
Aide Suares Lime Assurance Assistant
Maria Gineth Torres Quality Assurance Head
Hader Abel Lopez Export Supervisor

*COMMITTEE DECISION
Completion Date of Key Implementation Activities : (record the date when implementation is anticipated, the
change will have been implemented and can be closed).
(dd/mm/yy)

Update Control
Version Change No. Activity Responsible

III. CLOSING
*VERIFICATION OF KEY IMPLEMENTATION ACTIVITIES

Were key implementation activities carried out? conclusions and/or observations:

Date (dd/mm/yy) Quality Management Verification Manager Post

FM-01522 (10/17-
V11)
 No.

FM-01522 (10/17-
V11)
FM-01522 (10/17-
V11)
 Control confirmation

Updated version of the

documents.

Updated Format

ution of the activities of

FM-01522 (10/17-
V11)
 Signature (BPM)
d
is

ity
d

executed the key activities of

Quality

Quality Verification
Yeah No

Signature
(BPM)

FM-01522 (10/17-
V11)
 CURRENT PRODUCT: OP: _____________________ BATCH: __________________________ DESCRIPTION:_____________________________________________________________________
CLEARANCE OF LINEAYCONTROLENPROCESOARMADOCDP
LINE:___________________________________________________ DATE :__________________HOUR__________________

LINE CLEARANCE / PRODUCTION ASSISTANT - ROLE: PROCESS CONTROL RESPONSIBLE FOR ACTIVITY
PREVIOUS PRODUCT OP: BATCH: DESCRIPTION: ACTIVITY THE BPD FIRM ACTIVITY LoA FIRM BPD ACTIVITY THE BPD FIRM

FULFILL
ACTIVITY FULFILLS DATE / SHIFT DATE / SHIFT
S

Was the paperwork from the previous product removed?

Do you have the Batch Record with the complete op paperwork to

work on the line?

Are the waste and reject bins clean and identified?

Were the materials from the previous OP removed?

Are the line, MEE carts, MEE Baskets, trays and work implements
clean and identified with the OP and do the codes correspond to the
order to be worked?
The band was sanitized with 70% Ethanol. Expires on:
----------------------------------------------------------------------------------------------------------------------------------
Responsibl
Quality Notice Number: _______________ Responsible
e

DAMPER CLEARANCE CODING INFORMATION:

PRODUCTION ASSISTANT - ROLE: PROCESS CONTROL (WITNESS). At startup or every time
there is adjustment of information
or change of encoder, a new
FULFILL COMPLIANCE / witness must be placed and it must
ACTIVITY FULFILLS DATE / SHIFT be verified - signed with date, time
S DATA
by two people
Line clearance was carried out LEGAL INFORMATION (PDL, lots,
records, tone, expiration dates and
Do the material codes and packaging quantities correspond to the manufacturing)
order codes to be worked on? Note: If this space is not enough for
all the coding tokens, attach to the
The assembly expiration date corresponds to the first PT to expire back of this sheet or to a blank
according to the codes assigned to the order § sheet of paper.
Registration and legal standing coincide in components vs SAP (Select with an X which information
from the following list you should
encode).
Line clearance was carried out
The coding is legible and its location correct
2
Complies with sealing &

The container looks clean on the outside.

The PT meets the aesthetic presentation

The PT Labels Correspond DATA Date/ Date/ DATA Date/ Date/

The packaging is according to the packaging sheet SHIFT and TIME SHIFT and TIME

What is the number of box(es) inspected? F. EXPIRATION BATCH

Others #PACKAGE LABEL IT WAS REPORTED IN THE

LOG
UNITS/BOX PACKAGING CODE
CONTROL RESPONSIBLE CONTROL RESPONSIBLE
CORRUGATED
PACKER SIGNATURE
ISO TYPE:
APPROVED SUPERVISOR

Observations:
 Consecutive number:
BEL-STAR SA BATCH RECORD

Product name: Lot No.:

Production Order No.: Lot Size: Usefull lifetime:

No Document Check list

1 Production Order Form Packaging and Conditioning
2 Health Registration SAP Sheet (ZMM01)
3 SAP Sheet Production date and expiration (CO03)
4 Material Identification Label
5 Line Clearance Form and Controls in process CDP Arming
6 Line Identification
Responsible:

APPROVED BATCH RECORD:

NAME: DATE SIGNATURE
Production VB:

VB Quality: