RisK Management Index

5
 RisK Management Index

Risk Mangemenent Policy , Objectives and Context

Resbonsbilitis and Risk Management Team

Risk Management Criteria of Severity, Probability & Risk Evaluation

Coding Criteria

Risk Assessment
 Risk Management Policy

Orchidia commits to use risk based thinking and Risk structured strategy in or
for decision making, planning, achieve optimum control, minimize losses, a
resilience and learning.
Risk management system deploys to enhance accomplishment of the compa
the opportunities to achieve the firm’s vision.
Risk management has been built into the management processes as part of
work assigning the responsibilities through all levels and provision of needed
management objectives which its performance will be reviewed, Risk manage
be exposed to periodic review in response to events or change in
Risk management system that covers the firm foreseeable risks have pote
product quality and safety, the operators’ health and safety and the e

Risk Management Objectives

⎯ Increase the likelihood of achieving objectives
⎯ Encourage proactive management
⎯ Be aware of the need to identify and treat risk throughout the organization
⎯ Improve the identification of opportunities and threats
⎯ Comply with relevant legal and regulatory requirements and international no
⎯ Improve mandatory and voluntary reporting
⎯ Achieve governance of the firm resources
⎯ Improve stakeholder confidence and trust
⎯ Establish a reliable basis for decision making and planning
⎯ Improve process controls
⎯ Effectively resources utilization and allocation for risk prevention
⎯ Improve operational effectiveness and efficiency
⎯ Enhance health and safety performance, as well as environmental protectio
⎯ Improve loss prevention and incident management
⎯ Minimize losses
⎯ Improve organizational learning
⎯ Improve organizational resilience.

Risk Scope

The Risk activities will be applied to the following aspects:

1) The business (cost, supply, shareholders)
2) Product Quality, quality compliance, other compliance (e.g. regulatory or le
3) Product Safety & clinical use.
4) Employees Health & Safety
5) Environmental System
 Probability of Occurance

Rating Grading Description

>> An incident might happen every 50 years

1 Improbable >> Incident might be seen once during working life.
>> Impossibility of the occurrence under conditions
>> An incident might happen every 5-10 years
>> May see several incidents during working life
2 Remote >> Incident foreseeable but probability very low
>> Occurrence probability spreading to zero

>> An incident might happen every 1 - 5 years

>> An event could occur.
3 Occasional >> An incident may have happened at another business unit
>> Unlikely occurrence, but possible
>> One or more incidents might occur a year
4 Probable >> Personnel would not be surprised by incident
>> It can happen at some times in the life of the product
>> Significant number of incidents might occur each year
5 Frequent >> Incidents occur frequently
>> It can happen several times in the life of the product

Risk Evaluation

Severity （S）
Probability (P) 1 2 3 4 5
Insignificant Minor Moderate Major Catastrophic
1 Improbable 1 ACC 2 ACC 3 ACC 4 ACC 5 ALARA
2 Remote 2 ACC 4 ACC 6 ACC 8 ALARA 10 NACC
3 Occasional 3 ACC 6 ALARA 9 ALARA 12 NACC 15 NACC
4 Probable 4 ACC 8 ALARA 12 NACC 16 NACC 20 NACC

5 Frequent 5 ALARA 10 NACC 15 NACC 20 NACC 25 NACC

ACC widely ACCeptable area 1< RIV < 5

ALARA As Low As Reasonably Achievable 5 < RIV < 10
NACC Non ACCeptable 10 <= RIV <= 25
RIV Risk Index Value = severity（S）× probability（P)
 Coding System
I) Owner Department (XX)
item Code
Production PR
Quality Assurance QA
Quality Control QC
Research & development RD
Warehouse WH
Engineering EG
Human Resources HR
Medical MD
Validation VAL
Enviromental, Health & Safety EHS
Supply chain SC
Drug Regulatory Affairs RA
Business Development BD
Sales & Marketing SM
Export EX
II) Process (.X)
Item Code
Process no. 1 .A
Process no. 2 .B
Process no. 3 .C
Process no. 4 .D
Process no. 5 .E
III) Sub-process (.00)
Item Code
Sub-process no. 1 .01
Sub-process no. 2 .02
Sub-process no. 3 .03
Sub-process no. 4 .04
Sub-process no. 5 .05
IV) Potential Failure model (F00)
Item Code
Failure model 1 F01
Failure model 2 F02
Failure model 3 F03
Failure model 4 F04
Failure model 5 F05
V) Most Probable Origin [M.P.O] (X)
Item Code
Risk source no. 1 A
Risk source no. 2 B
Risk source no. 3 C
Risk source no. 4 D
Risk source no. 5 E
 VI) Potential Failure Effect ( /00)
Item Code
Potential failure effect no. 1 /01
Potential failure effect no. 2 /02
Potential failure effect no. 3 /03
Potential failure effect no. 4 /04
Potential failure effect no. 5 /05
VII) Contol Procedure Method (F00X/ 00RC00)
Item Code
Control Procedure Method no. 1 F00X/ 00RC01
Control Procedure Method no. 2 F00X/ 00RC02
Control Procedure Method no. 3 F00X/ 00RC03
Control Procedure Method no. 4 F00X/ 00RC04
Control Procedure Method no. 5 F00X/ 00RC05
 Potential Failure Mode / Most Probable Origin / Potential Failure Effect / Residual Risk
Process Sub-Process Risk Scope Initial Risk Assessment Control Procedure(s) Risk Re-Assessment Verification Responsibility Note(s)
Hazard Risk Source Harm Risk migitation

Risk Risk
Risk
Probability Severity Index Risk Strategy Method Due date Status Probability Severity Index Re- Column11 Column12 Column13 Column14 Column15
Code Description Code2 Description3 Code4 Description5 Description7 Description9 Column10 (P1) (S1) Value Evaluation (P2) (S2) Value
(RIV1) (RIV2) evaluation

1-Preparation of Not conducting TNA for all Coordination with

Training & Not covering all Company's Employee disstisfaction and HR-P-0006 FHR-P-
HR-A Development HR.A.01 HR.A.01.F01 employees (training need Product Quality 3 3 9 ALARA Managers & Conducting TNA done Active 1 3 3 ACC HR Specialist N/A N/A
annual training plan employees
analysis)
lack of productivity
Recruitment Unit
0006/01/02

Coordination with
Training plan is out of No alignment of Training Plan Employees will not receive Managers , Recruitment Prepare list of vendors for
HR.A.01.F02 Product Quality 3 3 9 ALARA all training programs with done Active 1 3 3 ACC HR-P-0006 HR Specialist N/A N/A
budget with budget required training programs Unit, and Finance
estimated cost
Departmnet

Coordination with HR Department is designing

Not covering all training No Assessment for employees employee dissatisfaction and OJT SOP to control
HR.A.01.F03 Product Quality 3 3 9 ALARA Managers & 9/30/2022 Inactive 1 3 3 ACC HR-P-0006 HR Specialist N/A N/A
needs before conducting TNA lack of productivity Recruitment Unit employee performance and
knowledge

Sending an e-mail to
Planning with Purchasing
2-preparaing training Lack of needed tools to lack of follow up or not Purchasing Department HR-P-0006, e-mail
HR.A.02 HR.A.02.F01 Inefficient Training Product Quality 4 2 8 ALARA Department & done Active 1 2 2 ACC HR Specialist N/A N/A
facilities support training programme budgeted Engineering with needed tools, ask & training tools
Engineering to check A/C

• Vendors will be late for Prepare list of vendors for

lack of follow up
3-Evaluation of training session Phone Calls & e-mails all training programs and
HR.A.03 training vendors HR.A.03.F01 • Provided training materials Not sufficient selection of Inefficient Training Product Quality 4 3 12 NACC with other vendors ask for evaluation sheets of done Active 1 3 3 ACC HR-P-0006 HR Specialist N/A N/A
are not effective and not other customers for the
vendors
covered all training aspects same training

Provide vendors with the

required outline that covers
the gaps and validate the
4-Implementation HR.A.04.F01 failure to perform TNA content by the Direct
Does not meet trainees failure to detect performance
HR.A.04 analysis with corrective Product Quality 4 3 12 NACC Outline check Manager of employees done Active 1 3 3 ACC HR-P-0006 HR Specialist N/A N/A
of training courses needs
methods
gaps
before proceeding

Concentrate of avoid any

failure of TNA

Provide vendors with the

required outline that covers
HR.A.04.F Poor Training Content low quality of vendors Training needs are not met Product Quality 4 3 12 NACC Outline check
the gaps and validate the
done Active 1 3 3 ACC HR-P-0006 HR Specialist N/A N/A
02 content by the Direct
Manager of employees
before proceeding

outlines are not redsigned to Follow up with vendors to

HR.A.04.F Training Delivery method is match delivery method and Training is not effective Product Quality 2 5 10 NACC Updated Outline check
make sure that outlines are
done Active 1 3 3 ACC HR-P-0006 HR Specialist N/A N/A
03 uneffective "Online" trainers are not trained on updated to match the new
online training delivery delivery method

5-Notification of Sending invitation to

HR.A.05 Trainers and HR.A.05.F Notifications are not
Failure to send notifications
Trainees shall not attend the
Product Quality 2 4 8 ALARA
setting Calendar with attendees with adequate
done Active 1 4 4 ACC HR-P-0006 HR Specialist N/A N/A
01 received by trainees training training Plan enough time to training
Traniees implementation

For all internal training

programs related to OJT
archiving will be responsible
for direct manager for each
HR.A.06
6-Archiving of HR.A.06.F Losing Training Records
Lack of documentation & Failure to present needed
Product Quality 3 3 9 ALARA constant follow up
department
9/30/2022 Inactive 1 3 3 ACC HR-P-0006 HR Specialist N/A N/A
training records 01 follow up records during auditing
For all external training
programs archiving will be
responsible for HR
department

7-Evaluation of Sending Dept. Manager

HR.A.07 HR.A.07.F No Accurate Evaluation
Failure to meet evaluation of
Training is not efficient Product Quality 3 2 6 ALARA Coordination with Depts outline to revise before done Active 2 2 4 ACC HR-P-0006 HR Specialist N/A N/A
training outline 01 TNA training confirmation

Setting a meeting with

8-Evaluation of Failure to follow up with [Link] to check the
HR.A.08 HR.A.08.F Training target is not managers about performance Performance Gap shall exist as Product Quality 3 4 12 NACC Coordination with Depts effectiveness of conducted done Active 1 4 4 ACC HR-P-0006, FHR-P- HR Specialist N/A N/A
Training outome 01 achieved progress is trainings on a quartelry 0006/11/02
basis

Performance submitting appraisal Not to send forms to new No follow up with New employees who were not Coordination with Coordination with
HR-B Appraisal HR.B.01 forms to employees HR.B.01.F01 employees who spent 3 receuitment with regard to included shall not receive Business 3 2 Err:507 ALARA Recruitment Recruitment and payroll done Active 2 2 Err:507 HR-P-0004 HR Specialist N/A N/A
months Hiring Dates incentive unit

Any new employee has to

attend the orientation
Not conducting orientation New employees shall not fill in Coordination with
HR.B.01.F02 Lack of follow up Business 3 2 Err:507 ALARA session which include done Active 2 2 Err:507 HR-P-0004 HR Specialist N/A N/A
on appraisal form appraisal forms correctly Recruitment
training on the performance
appraisal form
 No incentive shall be paid that
Alert Management Setting e-mail alert a week
HR.B.01.F03 Apprasial is not conducted No Clear Incentive Policy leads to employee Business 3 2 Err:507 ALARA done Active 2 2 Err:507 HR-P-0004 HR Specialist N/A N/A
System earlier prior to each quarter
demotivation

Receiving appraisal HR.B.02.F01 No performance indication has Sending an e-mail to Depts'

Not receiving appraisal No accurate follow up of
HR.B.02 been recorded and incentive Business 2 3 Err:507 ACC Coordination with Depts managers to remind them done Active 1 3 Err:507 HR-P-0004 HR Specialist N/A N/A
forms Forms from employees receiving forms
shall be paid with appraisals deadline

Revising appraisal Revising grading with

form in accordance HR.B.02.F02 No adehere to Incentive No equity between employees
Managers' evidence for
Policy nor Performance No Clear Incentive Policy who deserve high payment Business 2 3 Err:507 ACC Coordination with Depts done Active 1 3 Err:507 HR-P-0004 HR Specialist N/A N/A
with grading Appraisal SOP that leads to dissatisfaction outstanding & below
criteria expectations ratings

Recording of HR.B.02.F03 No documented record of Lack of Follow up No record of employees Business 3 2 Err:507 ALARA Alert Management Setting e-mail alert 10 days done Active 2 2 Err:507 HR-P-0004 HR Specialist N/A N/A
appraisal grades employees performance perfromance level System post receiving forms

Organaization's failure to Revising grading with

Analysis of HR.B.02.F04 No documented analysis of Lack of Follow up assess its performance & its Business 3 2 Err:507 ALARA Coordination with Depts Managers' evidence for done Active 2 2 Err:507 HR-P-0004 HR Specialist N/A N/A
appraisal grades organization performance future needs to achieve better outstanding & below
ranks expectations ratings

Recruitment / Use many channels of

HR.C.01 Sourcing
not finding qualified sourcing from many
HR-C selection HR.C.01.F01 recruitment channels delay the hiring process Business 3 3 Err:507 ALARA sourcing to avoid lack of done Active 2 2 Err:507 ACC HR-P-0001 HR Specialist N/A N/A
Candidates candidates channels
process qualified candidates

• Assists the hiring

managers with
defining clear job skill use forms for job
specifications to wrong or missing Lack of communication with wrong selection for the use more than 1 specification with approval
HR.C.02 HR.C.02.F01 Business 2 4 Err:507 ACC methodology to validate done Active 2 2 Err:507 ACC HR-P-0001 HR Specialist N/A N/A
ensure appropriate information line managers calibers job specifications from direct manager and
identification of dep manager
candidates and
selection.

Conducting exit
interviews and
HR.C.03 recommends HR.C.03.F01 do not conduct exit Poor Organized process reason of turn over is unclear Business 2 3 Err:507 ACC develop more techniqes Conduct exit interview and done Active 1 1 Err:507 ACC HR-P-0001, HR-P- HR Specialist N/A N/A
procedures to interview after resignation to retain calibers Exit interview Form 0007
reduce absenteeism
and turnover.

Coordinates with
direct managers to Sending the assessment
ensure that the HR Forget to send the employee with low form before end probation
assessment mail/ or Lack of communication with
HR.C.04 new employees HR.C.04.F01 manager fail to send the line managers performance will complete his Business 3 3 9 ACC follow up with managers date by 7 days/ following up done Active 1 3 Err:507 ACC HR-P-0001 HR Specialist N/A N/A
passed the assessment result on time contract with managers by setting
calender to get response
probation
appraisal.

Recruit with hallow effect or applicants will be invited for

the first impression a serious of tests and
Consistency and interviews as per requested
HR.C.06 integrity of the HR.C.06.F01 Not hiring candidates with Relatives recruitment without Affects company's interests Business 3 2 6 ALARA panel interviews by each position done Active 1 2 Err:507 ACC HR-P-0001 HR Specialist N/A N/A
integrity and transparency make sure that they are and targets
interview process requirements / evaluation
qualified for the position
will be set via Talentera for
all requested partners

Using online tools to finish

the hiring process/ its
obilgatory to wear a mask
when you come to
Getting infection by Infection of employees by
Candidates who carry Covid- interview or contract
HR.C.07 Covid-19 by any HR.C.07.F01 19 virus Candidates Covid-19 & Spread of Business 3 5 Err:507 NACC Online Recruitment signing or any event at the done Active 1 4 Err:507 ACC HR-P-0001 HR Specialist N/A N/A
coming candidate pabdamic at company
company/ also its obligatory
to have at least one dose
from any vaccine to enter
the copmany for any reason

Using panel interviews,

HR.C.08 Interviews HR.C.08.F01 Hiring the wrong candidate conducting interviews in Turnover Business 3 3 Err:507 ALARA Assessments assessments and tests to done Active 2 1 Err:507 ACC HR-P-0001 HR Specialist N/A N/A
wrong way make sure that we will hire
the most suitable candidate

0
• Inserting all salary
HR-D Salary Payment HR.D.01 effects on OHR HR.D.01.F01 Breakdown in the system HR electronic System failure Delay for salary payment Business 3 2 6 ALARA Coordination with ofouq contract with OFOOQ for NA Active 1 2 2 ACC contract & HR Specialsit
used to calculate salaries periodic technical support agreement
system
1. on job training on system
2. make sure there are no
HR.D.01.F02 data entry in-accurate untrained individual Delay for salary payment Business 4 2 8 ALARA Coordination with ofouq problems with all NA Active 1 2 2 ACC HR-P-0006 HR Specialsit
employee's attendance
within the month

• starting salary review data before and contract &

HR.D.02 HR.D.02.F01 in accurate calculation in accurate data Delay for salary payment Business 3 2 6 ALARA Revision NA Active 1 2 2 ACC HR Specialsit
calculation after data entry agreement
• transfering salaries
• a malfunction in the bank's Coordination with IT informing IT dep. to take
HR.D.03 to employee's bank HR.D.03.F01 Internet service interruption Delay for salary payment Business 2 3 6 ALARA NA Active 1 3 3 ACC communication HR & IT
payroll conversion system Dept. the needed action
accounts
 • lack of sufficient cashflow
HR.D.03.F02 in the company's account to • The company did not Delay for salary payment Business 2 3 6 ALARA Coordination with communicate with finance NA Active 1 3 3 ACC communication HR & finnance
achieve the sales target Fiance Dept. dep.
cover the amount paid

Incentives / Incentives / Annual Delay for incentive / annual review data before and contract &
HR-E HR-E-01 HR-E-01.F01 in accurate calculation in accurate data Business 3 3 9 ALARA Revision NA Active 1 3 3 ACC HR Specialsit
Annual profits profits calculation profit payment after data entry agreement

• a malfunction in the bank's Delay for incentive / annual Coordination with IT informing IT dep. to take
HR-E-01.F02 • Internet service interruption Business 3 3 9 ALARA NA Active 1 3 3 ACC communication HR & IT
payroll conversion system profit payment Dept. the needed action

• lack of sufficient cashflow

HR-E-01.F03 in the company's account to • The company did not Delay for incentive / annual Business 3 3 9 ALARA Coordination with communicate with finance NA Active 1 3 3 ACC communication HR & finance
achieve the sales target profit payment Fiance Dept. dep.
cover the amount paid

Not conducting Medical

Checkup may lead to the
Medical • Pre-Hiring Medical • Hiring physically unfit • Not conducting Pre-Hiring possibility of hiring employees Coordination with medical check up is done HR-P-0003 medical
HR-F Checkup HR-F-01 Checkup HR-F-01-F01 employees Medical Checkup who are not physically fit Business 3 2 6 ALARA Recruitment for all employee before done Active 1 2 2 ACC check up procedure HR
which affects the performance hiring as a requirement
of their functions assigned to
them

medical check up is done

for determining the job that
• Hiring staff who suffering match with their deasease
• Hiring medically unfit • Not conducting Pre-Hiring Coordination with HR-P-0003 medical
HR-F-01-F02 from serious diseases will Business 3 4 12 NACC and not contact with the done Active 1 3 3 ACC HR
employees Medical Checkup affect the quality of products Recruitment production process to not check up procedure
affect on the conformity of
the product

a notification is send to
head of each department
by the names of the
employees required for the
Affecting the finished product periodic medical check up
such as departments according to a determined
(production - laboratory - schedule, with time
engineering) as a result of intervals based on the
Periodic Staff Medical •Not conducting Periodic • A staff member fails to exposure to some chemicals or Coordination with all severity of their process as HR-P-0003 medical
HR-F-02 HR-F-02-F01 attend periodic medical the result of their work within Business 3 4 12 NACC the sterile area & Cafeteria done Active 1 3 3 ACC HR
Checkup Staff Medical Checkup tech sector check up procedure
checkup the sterile area, which is officers done every 6
preparing the product may months with complete
affect their health and affect medical check up to every
the final product of the one year for the packaging
company stuff. the rest of production
employees and all
employees who require
their job to deal with the
product

Affecting the finished product

such as departments
(production - laboratory -
engineering) as a result of our company mede an
• if there are any problem
exposure to some chemicals or coordination with agraggrement with 2
HR-F-02-F02 •Not conducting Periodic technically or nontechnical in Business 3 4 12 NACC done Active 1 3 3 ACC contract HR Specialsit
the result of their work within hospital and medical different hospitals to avoid
Staff Medical Checkup the hospital where we are agreement
conducting the checkup. the sterile area, which is insurance company any delaying could happen
preparing the product may in the monthly process
affect their health and affect
the final product of the
company

Interruption of service and

lead to the interruption of
communication and the
annual budget is not enough inability of employees to make make the right forcasting at
Mobile service • Pay mobile bills for • Not providing phone bills contract
HR-G for employees HR-G-01 employees HR-G-01-F01 for employees for covering Mobile service internal and external calls, Business 2 3 6 ACC communicate with finance dep.
the beginning of every year done Active 1 3 3 ACC agreement HR Specialsit
for employees which are in favor of work to avoid the lack of budget
primarily, which results in the
interruption of work and
productivity of employees

Interruption of service and

lead to the interruption of
communication and the
Delay by finance Dept. for inability of employees to make keep following up with
• Delay of paying Monthly communicate with contract
HR-G-01-F02 Mobile bill finalizing the bank transfer to internal and external calls, Business 2 3 6 ACC finance dep. finace team before bank done Active 1 3 3 ACC agreement HR Specialsit
pay Mobile bills which are in favor of work transfer at least a week
primarily, which results in the
interruption of work and
productivity of employees
 Employees' discontent and
lack of sense of safety for
employees who work in jobs
that may expose them to
• Medical Insurance • Not providing Medical annual budget is not enough injury or injuries during their make the right forcasting at contract
HR-H Insurance HR-H-01 HR-H-01-F01 for covering medical Business 4 3 12 NACC communicate with finance dep.
the beginning of every year done Active 1 3 3 ACC HR Specialsit
for employees Insurance for employees training for their jobs, which agreement
insurance for employees to avoid the lack of budget
affects the employees and
makes them do their work
strictly affecting the overall
productivity of the company

Employees' discontent and

lack of sense of safety for
employees who work in jobs communicate with 1. contracting with medical
medical insurance
that may expose them to insurance company with a
• medical insurance company company gradually to
• changing in service level of injury or injuries during their good pervious work contract
medical insurance company can't cover all employees training for their jobs, which Business 3 3 9 ALARA ensure that all 2. satisfaction survey every done Active 1 3 3 ACC agreement HR Specialsit
requerment agrrement points that
affects the employees and we contracted for are year to find weak points
makes them do their work covered with quality and measure satisfation
strictly affecting the overall
productivity of the company

cancellation of the contract

with Insurance company,
which will increase the
resentment of employees due
• Providing • annual budget is not to loss of savings in the case of make the right forcasting at
• Not Providing pension and contract
HR-H-02 retirement and life HR-H-02-F01 enough for covering medical pension insurance and also Business 3 3 9 ALARAcommunicate with finance dep.
the beginning of every year done Active 1 3 3 ACC HR Specialsit
life insurance agreement
insurance insurance for employees lack of sense of safety for loss to avoid the lack of budget
of opportunities for their heirs
in the payment of the amount
of life insurance In case of
death

cancellation of the contract

with Insurance company,
which will increase the
resentment of employees due communicate with
• lack of sufficient cashflow in to loss of savings in the case of finance dep. To ensure 3. continuous
• Delay of paying Monthly contract
HR-H-02-F02 the company's account to pension insurance and also Business 3 3 9 ALARA that the account is communication with done Active 1 3 3 ACC HR Specialsit
and quarterly insurance bill agreement
cover the amount paid lack of sense of safety for loss covered with sufficient insurance company
of opportunities for their heirs amount of money
1- Gradation in the payment of the amount
wages( Anyone who of life insurance In case of
has spent one year death
from 1/1 to 31/1 will
receive an annual
increase 7%) annualy
0
0 0

Preparing
registers of the periodically updating and
HR-I Labor Office HR.I.01 HR.I.01.F01 Infraction for labor law no register for gradation average mulct for every Business 5 1 5 ALARA constant follow up revision, & commitment of day 1 each Active 1 1 1 ACC item 45 labor law HR Specialsit
&social wages employee 500 L.E labor law month 12 for 2003
insurance

annual increases less than make continuously

Business 5 1 5 ALARA
legal percentage revision

2- Emergency subsidy
(Pay 1% from the
basic monthly social mulct 50% for first time and periodically updating and day 1 each law 156 fro 2002
HR.I.02 insurance salaries) HR.I.02.F01 Infraction for labor law financel dep Lateness 100% for another time Business 5 1 5 ALARA constant follow up revision, & commitment of month Active 1 1 1 ACC item 7 HR Specialsit
labor law
maximum day 15
monthly

forgetting to take extracting make continuously

Business 5 1 5 ALARA
cheque procedures revision

3- Penalties ( pay 1/3 periodically updating and

HR.I.03 of penalties every HR.I.03.F01 Infraction for labor law financel dep Lateness average mulct for every Business 5 1 5 ALARA constant follow up revision, & commitment of every month Active 1 1 1 ACC item 75 labor law HR Specialsit
semester ) employee 500 L.E labor law 12 for 2003

forgetting to take extracting

Business 5 1 5 ALARA
cheque procedures

4-pay indebtedness
periodically updating and
of social inaurance Infraction for social average mulct for every month item 75 labor law
HR.I.04 HR.I.04.F05 financel dep Lateness Business 5 1 5 ALARA constant follow up revision, & commitment of every month Active 1 1 1 ACC HR Specialsit
maximum day 15 insurance law 1% from indebetedness 12 for 2003
monthly labor law

forgetting to take extracting Business 5 1 5 ALARA make continuously

cheque procedures revision

5-Disable worker 5% complete disabled numbers

according to minimum market periodically updating and
HR.I.05 ( employement 5% HR.I.05.F01 Infraction for labor law lack of follow up [Link] order not to be Business 5 1 5 ALARA constant follow up revision, & commitment of every month Active 1 1 1 ACC law49 for 1982 item HR Specialsit
from workforce of 9/1
subjected to legal and financial labor law
the workforce
penalties

periodically updating and

6- renewal skills average mulct for every
HR.I.06 HR.I.06.F01 Infraction for labor law lack of follow up Business 5 1 5 ALARA constant follow up revision, & commitment of every month Active 1 1 1 ACC Law No. 12 of 2003 HR Specialsit
certificates employee 500 L.E
labor law
forgetting to take extracting make continuously
Business 5 1 5
skills certificates procedures revision
 7- Getting overtime There is no skills certificate in average mulct for every periodically updating and
HR.I.07 HR.I.07.F01 Infraction for labor law Business 5 1 5 ALARA constant follow up revision, & commitment of every month Active 1 1 1 ACC item 85 for 2003 HR Specialsit
permission the employee's file employee 500 L.E
labor law

periodically updating and

HR.I.08 8- renewal health HR.I.08.F01 Infraction for healthy lack of follow up Bad Image of the Company Business 5 1 5 ALARA Make continuously revision, & commitment of day 1 each Active 1 1 1 ACC Law No. 10 of 1966 HR Specialsit
certificates insurance law and penalty on the company revision month
labor law
COVID-19, exposure to
COVID-19 in the workplace
depends on the likelihood of
coming within 1 metre of
others, in having frequent
physical contact with people Suspension of
wearing musk during
infection from contact with who may be infected with examinations working hours and
new Corona patients COVID-19, and through infection with diseases Employee Safety 5 4 20 NACC precautionary vaccination for all every year 1 1 1 ACC Law No. 10 of 1966 HR Specialsit
contact with contaminated procedures for covid-19
employees
surfaces and objects. pandemic

9- Renewal contracts

send email to line

managers to decide if
will renew or not , In
case of non-renewal, The employee’s continued periodically updating and
work and the negative day 1 each
HR.I.09 an official letter will HR.I.09.F01 impact on performance and No alarm from HR. system bad performance Business 5 1 5 ALARA constant follow up revision, & commitment of month Active 1 1 1 ACC Law No. 12 of 2003 HR Specialsit
be sent to him or her the company labor law
and if we will renew
the employee will
sign on renewal letter

10-social insurance
for employees

send social insurance

form No 1 to social Delay previous company of periodically updating and
HR.I.10 insurance office HR.I.10.F01 The company is subject to new comer in social insurance Bad Image of the Company Business 5 1 5 ALARA constant follow up revision, & commitment of day 1 each Active 1 1 1 ACC social insurance law HR Specialsit
financial penalties increase cost of the operation month 79 for 1975
within 15 days from closing labor law
hiring date

11- issuing cars

insurance

Submit an application
for the issuance of a
car insurance Loss in sales and negative
delay in reciving the
certificate to social we can't extract license for attitude from employees periodically updating and day 1 each social insurance law
HR.I.11 HR.I.11.F01 documentation from legal Business 5 1 5 ALARA constant follow up Active 1 1 1 ACC HR Specialsit
insurance office any vehicle toward commitment of the revision, month 79 for 1975
department
within 2 days from company
pay social insurance
indebtedness

12-Signing contracts
signing contracts
with new comers periodically updating and
The papers of new comer are day 1 each
HR.I.12 according labor and HR.I.012.F01 Infraction for labor law not fulfilled late in recruitment process Business 5 1 5 ALARA constant follow up revision, & commitment of month Active 1 1 1 ACC Law No. 12 of 2003 HR Specialsit
social insurance labor law
labors

13-attendance
revision

revise the roles of

attendance to reach Delay in salary Non-review for attendance periodically updating and day 1 each
HR.I.13 zero effect in payroll HR.I.013.F01 transformation effects Bad Image of the Company Business 5 1 5 ALARA constant follow up revision, & commitment of month Active 1 1 1 ACC Law No. 12 of 2003 HR Specialsit
labor law
process

14-Vacation balance
preparation

No schedule for employees

Error in vacation periodically updating and
HR.I.14 balance & operation HR.I.014.F01 vacations, unfair distribution error in vacation calculation Bad Image of the Company Business 5 1 5 ALARA constant follow up revision, & commitment of day 1 each Active 1 1 1 ACC Law No. 12 of 2003 HR Specialsit
for vacations ,negative month
schedules labor law
attitude

Prepared by Reviewed by Approved by FQA-P-0011/02/01

QA Compliance
Manager :
Remon Raafat

Sign/Date: Sign/Date: Sign/Date:

 Resbonsibilities
Risk management and compliance board (RMCB)/Quality
committee

Risk management process owner (RMPO)

Risk Owner (RO)

Risk Team (RT)

Functional/Department Managers

Risk Mitigation Plan Owner (MPO) (Can be CAPA Supervisor)

 Risk Team

Name Position

1 Remon Raafat QA Manager

2 Dina Shaaban Compliance and CE Assignee

3 Kawther Shaaban Risk & CAPA Assessor

4 Mohamed Etman Production Manager

5 Mostafa Osama Production Section Head

6 Ahmed Sharaf R&D Manager

7 Ahmed Magdy R&D Section Head

8 Reham Saeed QC Manager
9 Marwa Fawzy QC Section Head

10 Bishoy Ramzy WH Manager

12 Mahmoud Adel WH Supervisor

13 Islam Mukhtar HR Supervisor

14 Mohamed Lafy Engineering Manager
15 Mahmoud Soliman Engineering Section Head
16 Mai Medhat Senior Medical Advisor
17 Khaled Fekry Legal Affairs
18 Ahmed Abdelaziz EHS Manager