Full PSCI SAQ & Final

1
Pharmaceutical Supply Chain Initiative (PSCI)

Self-Assessment Questionnaire and Audit Report
for Pharmaceutical Industry Suppliers
API, Dosage Formulation, Chemicals and Intermediate Chemical Manufacturers
GUIDANCE FOR COMPLETION
Sections marked in orange need to be filled in by the supplier before the audit. Sections marked in grey will be filled by the audit team during / after the
onsite audit. Please do not change the report format and do not change the answers given by the other party. Supplier and auditors are asked to complete all
questions that apply. If a question does not apply, please mark it NA (Not Applicable). We would expect the following types of suppliers to complete all the
questions: API, Dosage Formulation, Chemicals and Intermediate Chemical Manufacturers.
AUDITOR AND AUDIT REPORT INFORMATION

Report Number:

Report Owner: Note: this is the company paying for /sponsoring the audit. If a PSCI Member, the name should be removed before the report is uploaded
to the PSCI audit sharing platform
DD/MM/YYYY Date and Type DD/MM/YYYY

initial of Previous initial
Date of Audit:
follow up Audit (if follow up
other, please specify applicable): other, please specify
Audit Firm Name:

Lead Auditor Name: Title:
Names of further
Title:
auditors:
Phone Number: Email Address:
FACILITY DETAILS
Company Name: pharco pharmaciutcal
Site Name (if different):
October 2016 Version 4

Full PSCI SAQ & Audit Report Template for Core Suppliers, External Manufacturers, Component and Material Suppliers
2
Parent Company Name

(if applicable):
Site Street Address: Alex cairo desrt road km 31 amryia
Site
Site City: Alexandria State/Province/
County:
Site Postal/Zip Code: Site Country: Egypt
SITE CONTACT INFORMATION
Site Representative
DR Essam Elansary Title: G Manager
Name (host):
Phone Number: Email Address:
Management
Dr Mahmoud Baddr Title: G Plant Manager
Representative Name:
HSE (Health, Safety,
Environmental
Chemist E lsayed Soliman Mahgoub Title: E H S Director
Protection)
HR (Human Resources)
Mervt shahin Title: HR Director

3
EXECUTIVE SUMMARY
Overall findings Please check applicable box(es) and indicate the number of findings
Critical Number of Criticals Other Number of Others None
A Management Systems
B Ethics
C Labor
D Environmental Protection
E Health & Safety Compliance

and Risk Management
It is not possible in an audit, with a limited time frame, to identify every area requiring attention. It is the responsibility of the audited party to establish, implement and
maintain effective systems and procedures that comply with the regulatory requirements. Due to the size of the site only the most important buildings, facilities, and HSE
topics could be inspected or discussed during the audit.
Critical Findings: Are very high risk findings that require immediate action to protect human life, the health of employees or the environment; May result in loss of license to operate or
serious damage to reputation; Require immediate corrective action by the supplier; Need to be communicated to the audit sponsor prior to audit report finalization.
Other Findings: Are all other major or minor audit findings, which need to be corrected by the supplier in an appropriate period of time.
Attitude of workers (towards management, workplace, and the interview process):

Note: do not document information that could put the worker at risk
Attitude of management (to audit and audit process):

Summary of main findings:


4
Facility Background Information

API (active pharmaceutical ingredient) manufacture
Biological manufacture
Chemical manufacture
Contract Research Laboratories
Please indicate which of the following best describes this facility
Finished Formulations
(check all that apply):
Logistics / Warehouse
Primary Packaging
Other (please describe)
Comments:
Flood Volcanic Activity
Is the facility located in a region that has experienced any of the Earthquake Tsunami Impact
following natural disasters in the previous 50 years: Damaging windstorm Hurricane/Typhoon
Wildfires Tornado
Describe the type of work currently being, or proposed to be
performed at this facility (include product types such as the work in the facility started from warehouse by recipt of material and packag material through qc
antibiotics, solvents): lab testing the materiall and going to weighing preparation and packaging for antibiotics
Please describe the facility HSE (Health Safety & Environment) EHS facility in the company is one of directorate are working under the supervsion of general
resources (number of staff or time spent on HSE): manager to cover the company 24 hour per day all year
Please provide a copy of the company’s organization chart The No of staff 26 including 14 servises worker all staff are fully time the no of the staff are 8
indicating areas of expertise in HSE and whether they are full unversty degree (bechaler degree) 4 techenical school all are trained for safety 2 of staff have high
time. Please provide qualifications of the full time HSE people. er deploma of post gradute
What is the primary language spoken by the majority of the Is company sponsored housing provided to any contract or full time employees working at this
employees at this location? location? Yes No
Primary language: Arabic If yes, what is the approximate number of workers living in company-provided housing:
Other languages (spoken by at least 10% of the workforce):
Number of Employees/Workers by Category (Provide data for the entire site. Also, please note that there may be Male Female
workers/employees who fit into multiple categories and should be accounted for under each applicable category (i.e., there is overlap
between categories)
Total employee population onsite (including temporary, part-time and contract workers)
Full time employees/workers directly employed by the company 1532 115
Part-time employees/workers directly employed by the company
Indirect, contract or dispatch employees/workers
Employees/workers under the age of 18 - -
Migrant or Foreign Workers

5
Student workers (include students, apprentices and interns)

Manufacturing Area (m 2): 14000m2
Total Site Area (m2): 44000m2
Yes No
Does your company own the facility? If no, who owns the facility?
Waste water treatment plant? Yes No
If the facility is not owned by the parent company, are the Utilities? Yes No
following within your operational control? Security? Yes No
Management of the roadways? Yes No
Rural
Indicate if the site is in a rural, industrial, residential or mixed Industrial
commercial setting Residential
Mixed commercial setting
Please attach a local area map with water sources if available.
When was this site initially constructed? Please indicate the years
1987
of industrial use of the site.
MANAGEMENT SYSTEMS Self-Assessment Questionnaire - Questions marked with an asterisk (*) are Auditor Verification

6
for information only and should not be considered for potential findings by the auditor. Please provide observations, details, comments and
any supporting documents
Commitment and Accountability
1* Does the facility have any ethics, labor, OHSAS 18001 Yes No Yes No
environment, health and safety management ISO 14001 Yes No Comments
system accreditations, certifications, or awards?
ISO 50001 Yes No
SA 8000 Yes No
Investors in people Yes No
Other (e.g. Awards, OSHA VPP, EMAS) please
list: iso17025
2 Does management engage employees in open two- Yes No Yes No
way communication? Please explain :through open meeting monthly Comments
(e.g. Town Hall meetings, employee surveys,
management factory rounds, management-
employees Q&A sessions)
Legal and Customer Requirements

3* Are there any issues related to Ethics, Labor, Is there any ongoing litigation or regulatory Yes No
Environment, Health, and Safety (HSE) Regulatory notices with respect to regulatory compliance? Comments
Compliance? Yes No
Are there any historical major regulatory actions?
Yes No
Any continuous / prolonged situations where
regulatory compliance requirements are
exceeded (within the past 12 months)? Yes
No
Please explain:

4 Does the facility assess ongoing compliance with Yes No Yes No
Health, Safety, and Environment, Business Ethics Please explain: Labor office and safety office Comments
issues, and Labor regulations? found no violations during 2016 inspections
5 Does the facility ensure that suppliers and service Yes No Yes No
providers operate good practices with regard to the If yes, how?
PSCI Principles (i.e., labor, ethics, environment,
By on-site assessment / audit: Comments
health & safety, and management systems)
Yes No
By desk-top assessment (e.g. questionnaires):
Yes No

7
Please explain:according to OUTSOOURCING

QULAFICATION sop no A/O/005 AND A/O/0062
Risk Management
6 Does the facility use risk assessment and risk Business risks: Yes No Yes No
mitigation methodologies to assess and manage Reputation risks: Yes No Comments
business, reputation, and legal risks?
Legal risks: Yes No
Please explain: EHS/OP/005 ATTACH NO6
7 Does the facility have a process to manage change Yes No Yes No
control for HSE (e.g. raw materials, processes, Please explain: EHS division is part of a change Comments
personnel etc.)? control committee that assess the changes that
would have an impact on environmental health
and safety
8 Has the facility developed and implemented a site- Identification of the major facility dependencies Yes No
based Business Continuity Management plan that that can create business interruption at the site? Comments
includes the following elements: Yes No
A risk assessment of the identified dependencies
and developed a prioritized remediation of those
risks? Yes No
Prioritized key supply initiatives and determined
the recovery time objective for key production
areas? Yes No
Please explain:
9 Does the facility have security systems for Yes No Yes No
controlling physical access to the facilities? Please explain: Fingerprint access to critical Comments
areas and 24/7 security personnel
Documentation
10 Does the facility maintain documentation for key Yes No Yes No
issues? Does this include: Comments
Audit findings
Injury and Illness Logs
Worker Benefits and Pay Information
Inspections by Regulatory Agencies
Worker Complaints
Performance Assessments
Documentation of Training

8
Training and Competency

11 Are workers made aware of policies and Yes No Yes No
procedures, and are they trained accordingly? Please explain how policies and procedures are Comments
communicated and implemented: the policy for
integrted QUALITY system are issued in SOP no
A/0/063 attach one
Please describe trainings in each of the following

areas:
Ethics: all new employees upon hiring attach 2 for
core value of company
Labor: all new employees upon hiring
Environment, health & safety: all new employees
upon hiring are trained for EHS and identfy risk
and hazared in workplace after recieving
advanced trainng according to need of its
department
Emergency preparedness/response: all new
employees are trainned for emegency escape
and routin work and drill EHS/OP/011 attach no
3
Continual Improvement
12 Does the facility perform self-assessments and/or Yes No Yes No
internal audits to improve the effectiveness of its How often: monthly Comments
labor, ethics and HSE (Health, Safety &
Please explain:through the program of training
Environment) practices?
department
13 Does the facility have formal procedures to track Yes No Yes No
corrective actions to address recommendations Please explain :SOP no A/O/002 attach no4 Comments
from incident investigations and audits/inspection

findings to improve the effectiveness of labor, ethics
and HSE (Health, Safety & Environment) practices?

9
ETHICS Self-Assessment Questionnaire - Questions marked an asterisk (*) are for information only Auditor Verification
and should not be considered for potential findings by the auditor. Please provide observations, details, comments and
Business Integrity and Fair Competition
14 Does the facility have formal ethics Yes No Yes No
policies or Codes of Conduct that If yes, please indicate if the following are included: Comments
govern company and employee Business integrity and fair competition
business practices?
Anti-corruption Link or policy provided: Yes No
Investigation of employee concerns
Privacy
Please provide a web link to the policy on your web site, or
alternatively attach a copy of the policy to this questionnaire.
Comments:
15 Does the facility have tools or Yes No Yes No
processes to prevent corruption and Please explain :according to labor procedure attach no5 Comments
facilitation payments? If yes, are the following elements included:
- policy communicated to all employees Yes No
- periodical training Yes No
- effective monitoring system Yes No
16 Does the facility have tools or Yes No Yes No
processes to support fair Please explain:Our company belive in fair competation Comments
competition within the market of

operation/business environment?
(**Please note, fair competition
refers to competing companies, not
competition between employees)
17 Does the facility have a policy about Yes No Yes No
employees receiving gifts or favors Please explain: Comments
from external companies with whom Please provide a web link or attach a copy of the policy to this
your company does business? questionnaire. Link or policy provided: Yes No
18 Is there a company policy on giving Yes No Yes No

gifts and favors to Government Please explain: Comments
officials / external companies /
Please provide a web link or attach a copy of the policy to this
individuals that your company does
questionnaire. Link or policy provided: Yes No
business with?

10
Identification of Concerns
19 Does the facility have practices to Yes No Yes No
encourage employees to report Please explain :through open meeting and direct suguestion to top Comments
concerns without fear of reprisal managers
and ensure concerns are formally
investigated?
Privacy
20 Does the facility ensure Yes No Yes No
confidentiality and privacy of Please explain: Comments
information concerning companies,
individuals, workers, patient rights
and intellectual property?
Animal Welfare
21 Does the facility work with animals Yes No Yes No NA
as a part of their business? If yes, do you follow an industry standard to ensure that animals Comments
are treated humanely and to reduce the number of animal tests
(e.g. Association for Assessment and Accreditation of Laboratory
Animal Care International). Yes No
If yes, please indicate the Standard utilized:

11
LABOR Self-Assessment Questionnaire - Questions marked an asterisk (*) are for information only Auditor Verification
and should not be considered for potential findings by the auditor. Please provide observations, details, comments and
General
22 Does the facility have a policy Labor policy Yes No Yes No
(or statement of commitment) Does the policy cover: Comments
regarding labor practices?
Freely chosen employment: Yes No
Prohibition of child labor: Yes No Link or policy provided: Yes No
Freedom of Association: Yes No
Non-discrimination: Yes No
Non-harassment: Yes No
Recruiting and termination: Yes No
Wages: Yes No
Benefits: Yes No
Standard working hours: Yes No
Overtime: Yes No
Vacation: Yes No
Grievance mechanism: Yes No
Maternity / Paternity leave: Yes No
Leave due to short term sickness: Yes No
Leave due to long term sickness: Yes No
Accident/medical emergency at work: Yes No
Whistle blower policy: Yes No
Please provide a web link to the policy on your web site, or

alternatively attach a copy of the policy to this questionnaire.
Comments: ch/op/001
Freely Chosen Labor
23 Does the company ensure that Yes No Yes No
no forced, bonded or Please explain: By submitting invistegation history from Comments
involuntary prison labor is
employed?
24 Does the facility keep any Yes No Yes No
original documents belonging If yes, which documents :what about Military Certificate ? Comments
to employees (e.g., passports Please explain: only birthdate and militry certificate
or birth certificates) during the
term of employment?

12
25 Does the facility ensure that Yes No Yes No

employees are allowed to If security guards are on duty, does the site ensure that: Comments
freely leave the company
- Employees are not prevented from leaving the site after
property after regular working
time? regular working time? Yes No
- If personal searches are required, that they are carried out
in a discreet manner (e.g. respecting gender and privacy)?
Yes No
26 Does the facility disclose the Yes No Yes No

terms and conditions of Please explain: Through contract and basic training Comments
employment and termination to

a new employee prior to hiring
and in a language that workers
understand?
27 Where legally required, is Yes No Yes No
there a signed contract of Please explain: Two copies of contract one in employee file and one Comments
employment for every directly given to employee
employed employee, and is a
copy of this contract provided
to the employee?
Child Labor and Young Workers

28 Does the facility ensure that no Yes No Yes No
child labor takes place in their Age of Youngest Worker: older than 18 years Comments
operations?
Please explain how the use of child labor is prevented:
(Reference: ILO Convention #
What remediation measures are taken in the case that child labor is Please list the documents reviewed:
182)
detected? Please explain: No workers under 18 years
29 Does the facility ensure that Yes No NA Yes No
workers under age 18 are not Please explain: Comments
involved in hazardous or

strenuous or physically
demanding work? Total number of young workers:
Maximum working hours for young workers:
Please briefly describe the activities performed by young workers:

Non-Discrimination and Fair Treatment

13
30 Does the facility ensure that Yes No Yes No

there is no discrimination in Please explain how the facility prevents discrimination: Comments
hiring, compensation, access equal bebfit for both gender
to training, promotion, Please explain how the facility prevents harassment, coercion,
termination or retirement threatening behavior, physical abuse, sexual abuse, or verbal abuse
based on race, caste, national toward workers: according to penalty procedure
origin, religion, age, disability,
gender, marital status, sexual Please explain how employees are trained on discrimination and
orientation, union membership harassment prevention: : according to penalty procedure
or political affiliation and is a
corresponding policy in place? Please explain how can the employees report such incidents: by
reporting to its departments
31 Does the facility ensure fair Yes No Yes No

working conditions for Please explain: the company allow for all worker to use the restrant Comments
temporary workers and and all sevice in companys
contractors?
32 Does the facility ensure equal Yes No Yes No
opportunity amongst workers Please explain: the company give eqaull salery and benfit to difernt Comments
of different genders / gender
nationality / physical
capability?
Wages, Benefits, and Working Hours

33 Is overtime voluntary at the Yes No Yes No
facility (except for legally Please explain: Comments
defined situations of urgency - What is the legal max. overtime as per applicable law? Per
or emergencies that require
day 4 h per week 20 h per month 80 h
the full workforce)?
- How do you ensure that overtime is voluntary?
- How is overtime recorded? barcode system
- How is the overtime compensated? according to law 12
and compensation policy
34 Do employees have one full Yes No Yes No

day off for every seven-day Please explain: friday (weekend) Comments
period on average?

35 Does the total number of Yes No Yes No
weekly working hours Please explain: 40 hour basic +20 overtime Comments
(including overtime) per


14
employee not exceed 60 hours

(as required per ILO standard
on maximum working time of
60 hours per week) or less if
defined so by local law?
36 Does the facility ensure that all Yes No Yes No
wages are at or above the Lowest wage paid: Comments
legal minimum or industry
Legal minimum:
benchmark standards,
whichever is higher? Please explain:
37 Are workers paid in a timely Yes No Yes No
manner in line with local law? In which intervals? Comments
Please explain: monthly
Please explain how workers are paid
Cash Pay packet containing money and a pay slip
Cheque
Bank Transfer
Other
If other explain:
38* Does the facility provide Yes No Yes No

housing and/or living expenses If yes, please provide details on wage deductions (e.g. tax, social Comments
as partial or complete payment insurance, housing, transportation:
of wages for any employees?
Freedom of Association
39* Has the facility had labor Yes No Yes No
issues in the past three years? If yes, please describe any issues such as strikes, protests or work Comments
stoppages:
40 Are workers able to choose Yes No Yes No
whether or not to join labor If no, please explain: company worker union is present Comments
unions, workers’ councils, or

other collective bargaining
organizations?

15
ENVIRONMENTAL PROTECTION - Questions marked an asterisk (*) are for information only and Auditor Verification
should not be considered for potential findings by the auditor Please provide observations, details, comments and
General
41 Does the facility have written Policy: Yes No Yes No
environmental policy, procedures, Procedure: Yes No Comments
and practices?
Comments: company has integrated policy for Quality and EHS
Link or policy provided: Yes No
Please provide a copy of the policy and a list of procedure titles. List of procedures provided: Yes No
See attach of policy 1
42 Does the facility have documented Yes No Yes No
environmental objectives or goals If yes, please describe goals, metrics, and/or targets :the Comments
for performance improvement, company has a procedure no for objects and target and
including metrics and targets? metrics see attach no 5
43* Has the facility achieved any Yes No Yes No
improvements (goal or non-goal If yes, please explain: ISO 14001/2004 many program are done Comments
related) in environmental for improvement of environment
performance in the last three
years?
44* Has the facility experienced Yes No Yes No
pending or recent (last three years) If yes, please explain: Comments
environmental incidents (for

example, non-compliance events,
spills, notice of violation, fines or
other environmental events)?
45* Describe any procedures the facility Tracking and reduction programs exist for the following impacts: Yes No
has to measure and reduce Energy consumption: Comments
environmental impacts from
Yes No Program description: use solar system for water
operations.
boilers
Water consumption:
Yes No Program description: control of water
consumption
Amount of hazardous waste:
Yes No Program description: trainng for lean manfucture
Amount of non-hazardous waste:
Yes No Program description: trainng for lean manfucture
Greenhouse gas emissions:
Yes No Program description: uses of ferion 22

16
Does the facility publicly report data?

Yes No Program description:
If yes, where can the information be found:
46 If the site operates in a water Yes No NA Yes No NA
scarce region1, has the facility Please explain: the strategy based on good control of uses Comments
developed a long-term strategy for water and spreed in uses of treated wastewater and applay
future water sourcing and lean manfucure program
management?
Chemical Registrations
47 Is the site affected by a chemical Yes No NA Yes No NA
registration program such as EU If yes, please identify the program: Comments
REACH (Registration, Evaluation;

Assessment, Authorization and
Restriction of Chemicals), China In case of yes, do you have a process in place to comply with
REACH, or TSCA (Toxic the regulation?
Substances Control Act) which Yes No NA
requires registration or
authorization to import or use a If yes, is the process applied to comply with regulations in:
specific compound?
Finished Products produced in the site
Yes No NA
Please explain:
Raw materials used for finished products

Yes No NA
Please explain:
Other
Yes No NA
Please explain:
48 Do you send material to a region Yes No Yes No NA

where REACH or similar If yes, how do you ensure compliance in this region and what is Comments
regulations apply? your role in this case?
1
Water scarcity is defined by the UN Food and Agriculture Organization as: (i) scarcity in availability of fresh water of acceptable quality with respect to aggregated demand, in the simple case of physical
water shortage; (ii) scarcity in access to water services, because of the failure of institutions in place to ensure reliable supply of water to users; (iii) scarcity due to the lack of adequate infrastructure,
irrespective of the level of water resources, due to financial constraints. In the last two cases, countries may have a relatively high level of water resources endowment, but are unable to capture and distribute
them because of limited financial resources for infrastructure development or lack of institutional capacity to maintain and manage them appropriately. (UN FAO,
http://www.fao.org/nr/water/topics_scarcity.html)

17
Environmental Authorizations
49 Does the facility have the required Yes No NA Yes No NA
environmental permits or Comments
If yes, please list the permit type, the name of the permit, and
authorizations? the expiry date: low 4 environmental assessement for new
and for operational licens
Waste and Emissions

50 Does the facility have a process to Yes No NA Yes No NA
select and manage third-party What records or documentations of waste disposal are Comments
waste treatment and disposal maintained: non hazardous waste records and hazardous
facilities and service providers? waste rrecords
Please provide specific details on land filling of waste
(categories and volumes): contract and SOP. No.EHS/O/007
AND SOP EHS/O/008 WASTE MANAGEMENT PROGRAM
SOP NO EHS/O/023
51 Does the facility use any of the Disposal Off-site On-site Yes No
following waste disposal methods & method Comments
locations (explain as applicable)?

Incineration Please explain: Please explain: Yes No
Through contractor with Comments
unico company
Landfill Please explain: Please explain: Yes No
through the company of Comments
nahdat misr
Deep Well Please explain: Please explain: Yes No
Comments

Land Please explain: Please explain: Yes No
Application Comments

Other Please explain: Please explain: Yes No
classfiication of Comments
domastic waste to
recycle certain item like

18
paper, wood, iron, metal,

PlHD and PLD
52 Indicate which methods are used to On-site wastewater treatment: Yes No Please describe: Yes No
manage process wastewater from Comments
this facility. Discharge to an offsite treatment facility: Yes No Please
describe:
Discharge to a settling pond or other surface water (e.g., river,
lake, ocean):
Yes No Please describe:
Collection and transfer to a waste management
facility/company:
Yes No Please describe: the company has wastewater
unit carry secondry treatment for biological type Other, e.g.
wastewater for irrigation: Yes No Please describe:
53 Indicate which of Generated? Yes No
the following Emission Type Emission control systems used Comments
types of air

emissions are
generated at the Yes No Ventilation Yes No
facility. Describe Volatile organic
Comments
the types of chemicals

pollution control
activities if used. Corrosive Yes No Yes No
vapors (e.g Comments
acid, caustic)
Yes No Use of scrapers and HEPA filters to Yes No
Particulates or collect in bags to be sent to the Comments
dusts incinerator
Ozone Yes No Yes No
depleting Comments
substances
Yes No adjust of fire combustion Yes No
Combustion
Comments
by-products

Other Yes No Yes No
Pollutants (e.g., Comments
GHG,

19
cyanides,
sulfides,
ammonias,
bromines,
phosgene)
54 Has the facility developed and Yes No Yes No
implemented a hazardous Please explain and list site hazardous substances: SOP. Comments
substances management program traning the company has trained all employee involved in
that includes development and hazardous chemical for RTK and separate the inflammable
maintenance of a current inventory material in special storage
of all hazardous chemicals used,
manufactured or stored on-site,
including those for production,
maintenance, utilities, and
laboratory purposes?
55 Has the facility developed and Yes No Yes No

implemented waste and wastewater Do the practices cover: Comments
management practices? Characterization of all wastes generated at the facility, including
returned products, with regard to regulatory classification (e.g.
hazardous waste, special waste, infectious waste, non-
regulated solid waste, low-level radioactive waste) and
hazardous properties (e.g. flammability, corrosively, toxicity)?
Yes No
Are wastes that contain Active Pharmaceutical Ingredients
(APIs) managed in such a way that the API is destroyed via that
waste management method? Yes No
Are there procedures in place to ensure that API, drug product,
and branded materials are not diverted from the
appropriate/authorized waste treatment/disposal
method/facility? Yes No
Does the facility have a system for collecting water from fire
fighting? Yes No
Does the facility evaluate the discharge of wastewater to
surface waters, onsite treatment works or offsite treatment to
determine potential Active Pharmaceutical Ingredient (API) /
environmental impact? Yes No
(Evaluation may include: treatability, bioaccumulation potential, bio-
toxicity potential, and the capacity of on-site treatment works, off-site
treatment works, or Publicly Owned Treatment Works (POTWs)

20
receiving the wastewater discharges to effectively perform treatment)

Are APIs in wastewater subject to treatment, capture, and
containment practices to reduce API concentrations to
predicted no effect concentration (PNEC) levels?
Yes No Comments:
Spills and Releases
56 If the facility uses hazardous Yes No NA Yes No
substances, is there a spill Five highest volume environmental impact substances: ethyl Comments
containment system? alcohol, isopropyl alcohol, acetone, methyl alcohol and
List the five highest volume methylene chloride
hazardous substances stored. Method of storage and containment system: storage in
Please indicate the method of flammable storage
storage (e.g., large storage Comments: storage in cylinders uses 3M spillage kits
cylinders, drums, above ground
tanks, underground tanks) and spill
containment system.
57 Does the facility have any known Yes No Yes No
soil or groundwater contamination? If yes, please provide a brief description of how this is being Comments
managed and whether it impacts neighboring properties:
58 Has the facility addressed potential Underground storage tanks, transfer lines, and sumps? Yes No
environmental risks arising from Yes No NA Please explain: solar tank put in concreat Comments
storing and handling hazardous chamber well isollated and observed in case of spillage
substances, including petroleum Secondary containment in the form of double walled tank and
products, as follows: piping or an external vault with a capacity equivalent to 110% of
the largest tank or vessel in the containment area?
Yes No NA Please explain:
A leak detection system capable of detecting a leak and
providing notification prior to the hazardous substance entering
the environment?
Overfill protection (for underground storage tanks) consisting of
an audible or visual alarm system and automatic fill shut-off, or
overfill protection (i.e., containment) and equipped with a
means of accurately determining the volume stored in the tank?
59 Are tank truck, railcar, and other Yes No NA Yes No
bulk transportation unit loading and Please explain: Comments
unloading areas for hazardous

substances provided with

21
containment equivalent to at least

110% of the largest transportation
unit handled in that area, or for
compartmentalized transportation
units, equivalent to at least 110% of
the single largest compartment?
HEALTH & SAFETY COMPLIANCE AND RISK MANAGEMENT Self-Assessment Questionnaire Auditor Verification
Questions marked an asterisk (*) are for information only and should not be considered for potential Please provide observations, details, comments and
findings by the auditor. any supporting documents
General
60 Does the facility have a written Health & Safety Policy: Yes No Yes No
policy, procedures, and practices? Procedures: Yes No Comments
If yes, provide a copy of the policy and list the
procedure titles: integrated system for quality Link or policy provided: Yes No
EHS policy List of procedures provided: Yes No
61 Does the facility have any documented Health & Yes No Yes No
Safety objectives and targets or goals for Please describe: attach copy of procedure Comments
performance improvement, including metrics?

62* Have any significant Health & Safety incidents Yes No Yes No
occurred at this facility over the past three years? If yes, please describe: Comments
(Significant incidents are defined as: causing

serious injuries or fatalities; a fire resulting in
damage to process equipment, building, storage
areas; physical explosions, fines or violations.)
63 Does the facility provide HSE (Health, Safety & New employee orientation and HSE training: Yes Yes No
Environment) training to employees (full-time, No Comments
temporary, or contractor)? Annual HSE refresher training: Yes No
Pre-start up process specific HSE training: Yes
No
Employee emergency response action training:
Yes No
Hazard Communication, Yes No
Process Safety Management, Yes No
Environmental Practices: Yes No
Comments:

22
64* Provide the facility’s lost time incident rate (number Last year 0.1 day Yes No
of lost work day cases multiplied by 200,000 Two years ago 23.4 day Comments
divided by the number of hours worked per year)
Three years ago 18.7day
for the last three years.
Do not track
65* Does the site have a program for improving safe Yes No Yes No
behaviors? If yes, please describe :by training the employee Comments

66 Does the facility ensure the provision of safe and Yes No Yes No
potable drinking water and hygienic facilities to all Please explain: supply of healthy water for many Comments
employees? site of labor
67 Does the company provide adequate sanitary Yes No Yes No
facilities (e.g. clean toilets, possibilities for hand- Please explain: the company cover all assemply Comments
washing). by clean toiltes near locker and hand washing for
labor and vistor at the entrance of production
area and in toiltes
68 If living accommodation (e.g. dormitories) are Yes No Yes No
provided to employees or contractors, are they Please explain: Comments
safe and clean, and do they meet the relevant

basic requirements (e.g. fire protection and
emergency)?
Worker Protection
69 Does the facility have a safe work permit system Hot Work: Yes No NA Yes No
for the following? Confined Space Work: Yes No NA Comments
Energy Isolation or Lock Out/Tag Out: Yes No
NA
Line Breaking: Yes No NA
Work at Height: Yes No NA
Other: Yes No
Please describe: all hazardous work are
protected
70 Has the facility developed and implemented an Installation of lockable disconnects interlocks, Yes No
Electrical Safety Program that includes: and emergency stop devices? Comments
Yes No
Labeling of switches, outlets, breakers, panels,
and disconnects? Yes No
Installation of special electrical equipment for
flammable vapors, gases, combustible dusts,

23
and wet areas? Yes No

Periodic testing of grounding and bonding
circuits, lightning arresters, and electrical
distribution equipment? Yes No
Permitting only trained and qualified employees
to perform electrical work?
Yes No
Providing awareness training for all employees?
Yes No
Designating keep clear areas around electrical
equipment for safe work practices? Yes No
Electrical cabinets are locked? Yes No
Emergency power supplies for relevant
equipment present? Yes No
Arc Flash Analysis? Yes No
Comments:
71 Has the facility developed and implemented Yes No NA Yes No NA
machine guarding procedures? Comments: Comments

72 Do safety symbols indicate the different hazards in Yes No NA Yes No NA

the machines? Comments: safety sign are present Comments:
73 Does the facility use any of the following processes Contractor pre-approval: Yes No Yes No
for managing risks related to contractor activity Training/orientation before entry: Comments
onsite?
Yes No
Electronic access control: Yes No
Drug/alcohol testing: Yes No
On-going recurrent safety training:
Yes No
Mandatory accident reporting: Yes No
Other: Yes No
If yes, please describe:
74 Are the facility’s pedestrian and material handling Yes No Yes No
equipment aisles marked or designated? Please explain: Comments

24

75 Has the facility developed and implemented a Yes No Yes No
formal program to provide for the selection and Does it include: Comments
maintenance of Material Handling Equipment? Operation by trained persons? Yes No
Periodic inspection and preventive maintenance
by qualified personnel?
Yes No
If elevated work devices are used is appropriate
fall protection equipment in place and is a rescue
plan in place?
Yes No
Please explain: monthly inspected all elment
76 Are the facility receiving and/or shipping docks Yes No Yes No
equipped with wheel chocks, dock locking systems Please explain: type of lock or mechanism of Comments
or other means of trailer restraint to prevent trailers action
from moving during loading/unloading?
77 Is product stored overhead in pallet racking stretch Yes No Yes No
wrapped or secured by some means to prevent it Please explain: according to SOP of warehouse Comments
from falling? rackange
78 Are conveyor systems or other overhead Yes No Yes No
equipment conveying materials adequately Please explain: do we have over head conveying Comments
protected (side rails, netting, emergency stops, systems ?
etc.) to prevent product from falling over the sides
especially in situations where conveyed product
might stop or hang causing jams or pile-ups of
material (curves, bends, etc.)?
79 Does the facility have practices to ensure pallet Yes No Yes No

racking is maintained in good condition and Please explain: what is the inspection interval ? Comments
regularly inspected (no obvious damages to what is the procedure ?
components – especially uprights – cross beams Monthly interval
locked in place, foot plates secured to floor, and
capacity posted)?
80 Does the facility have a system to evaluate Yes No Yes No

materials stored in the warehouse to ensure that Please explain: what is the system ?? Comments
special storage requirements are identified (e.g. All flammable material are identify stored in

25
flammable storage, segregation of non-compatible special storage

materials, containment, etc.)?
Occupational Health and Industrial Hygiene

81 Has the facility established practices to eliminate Use fewer hazardous substances when Yes No NA
hazards of substances using the following possible? Yes No NA Comments
hierarchy of exposure control: Please explain: exchange the acetone in couting
by water in some drugs
Provide engineering controls, such as local
exhaust, process isolation/containment, or
interlock system?
Yes No NA
Please explain: the company use ventalation
system and isolation of process
82 Does the facility perform risk assessments for Yes No Yes No
chemicals handled? Check those which apply: Comments
Please specify the types of engineering controls Laminar flow hoods:
used to manage identified chemical exposure
Down flow booths:
risks?
Powder transfer systems:
Alpha-beta valves:
Split butterfly valve:
Soft or hard wall isolators:
Local exhaust ventilation:
Closed processes:
Please explain: uses laminar flow hood in
weighing area local ventalation in allarea of
prepareation tablet comperesing powder filling
83 Has the facility established occupational exposure Yes No NA Yes No NA

levels for all Active Pharmaceutical Ingredients If yes, please explain the program to assess risk Comments
(API) and hazardous substances? and how exposure limits are determined to set
employee exposures to API, chemical, biological,
and physical hazards: through assess the risk
and expoure for worker and according to law 4

26
and law 12 we use the creatrea of tlv

84 Has the facility established exposure control Yes No NA Yes No
capabilities for handling pharmaceutical < 1g/m 3
Comments
compounds?
1-10 g/m3
Please specify the lowest control range of
containment for dust/powder handling that has 10-100 g/m3
been achieved. >100 g/m3
Comments: expoure in all level under 10mg/m3
85 Does the facility perform risk-based medical Pre-employment physicals: Yes No Yes No
monitoring or employee health surveillance which Routine blood monitoring: Yes No Comments
includes recording, investigation and follow-up?
Routine urinalysis: Yes No
Lung function testing: Yes No
Hearing test: Yes No
Other: Yes No
If yes, please describe: HCV and non legal drugs
(opium tramadol -etc)
86 Has the facility developed and implemented a plan Yes No Please explain: Yes No
to protect First Aid Responders and Medical Does the program include: Comments
Professionals from exposure to body fluids? Training? Yes No
Exposure response kits regularly checked? Yes
No
The offer of Hepatitis B vaccinations?
Yes No
87 Does the facility perform exposure monitoring for Solvent vapors: Yes No NA Yes No NA
the following health and safety risks? Workplace noise levels: Yes No NA Comments
Pharmaceutical powders: Yes No NA
Radiation levels: Yes No NA
Oxygen-deficient atmospheres (e.g. nitrogen,
inert gases): Yes No NA
Ergonomics (height lifting, climat , illumination,
vibrations, ..): Yes No NA
Other: Yes No
If yes, please describe: company set procedure
to meaure all expoure in workplace environment
88 Is there a site procedure to inform employees of Yes No NA Yes No NA
the results of exposure evaluations and monitoring Comments: EHS division inform employees with Comments
results?

27
the result of medical check

89 Does the site provide Personal Protective Yes No Yes No
Equipment (PPE) for face, eye, foot, head, body Please explain: PPE equipment are available for Comments
and hand protection? all employees as per area/regulatory
requirements
90 Does the facility rely primarily on respiratory Respiratory protective devices Yes No Yes No
protective devices and/or engineering controls to Engineering controls Yes No Comments
protect employees who handle chemicals to
Both Yes No Please explain: need
achieve exposure levels below the exposure limit?
examples ? use air line devices in certain area
and apply local ventilation in all area
91 Does the facility use any of the following Supplied air breathing systems Yes No Yes No
respiratory protection equipment for worker Powered air purifying respirators Yes No Comments
protection against exposure to chemicals or
Full face respirators Yes No
pharmaceutical compounds?
Half face respirators Yes No
Filtering face masks Yes No
Other Yes No If yes, describe:
What criteria are used to select respirator
protection devices? ANSI Spcification low 12
Respiratory Protection is not used?
Please explain if not applicable:
92 Are there provisions for fit testing, training, use, Yes No NA Yes No NA
cleaning, inspecting, storing, and maintenance of Please explain: examples ? SOP Comments
respirators? NumbersEHS/O/018 attach8
Sop no
Process Safety
93* Please indicate the top 3 most hazardous process 1. handling of potent Yes No NA
activities conducted at this facility (e.g. 2. fumgation Comments
hydrogenation, handling potent compounds,
3. handaling of flamable material
handling biological agents, handling flammable
materials).
94 Does the facility have processes to manage Yes No NA Yes No NA
chemical hazards safely in order to prevent If yes, please explain: use chemical safety Comments
catastrophic events involving highly toxic, program
flammable, reactive and/or corrosive substances?
95* Does the facility use any of the following Maintain temperatures below flash points: Yes Yes No NA
precautions to prevent ignition of flammable liquids, No NA Comments

28
vapors, powders, and gases in processing Nitrogen as inerting gas: Yes No
operations (including storage, transfer and Explosive vapor monitoring in process
charging)? equipment: Yes No
Oxygen level monitoring in process equipment:
Yes No
Grounding/bonding systems: Yes No
Anti-static treated working surfaces: Yes No
Other: Yes No If yes, describe:
96 Does the facility have adequate mechanical System Frequency of Yes No NA
integrity and safe operation of the following Pressure safety relief Inspection: monthly Comments
components including a periodic inspection of their valves/rupture disks Comments:
correct operation? Yes No NA
Bonding/ earthing
systems
Yes No NA
Mass transfer systems
(e.g. piping systems)
Yes No NA
Pressurized vessels
Yes No NA
Explosion prevention
system (e.g., prevention
of static electrical
discharge)
Yes No NA
Other: Yes No
If yes, please describe:

97 Does the facility provide a means for handling Not applicable Yes No NA
compressed gases safely that includes: Inspection and approval before acceptance of Comments
delivery? Yes No
Storage in a segregated area designed for
compressed gases? Yes No
Separation or barriers to manage compatibility
issues? Yes No
Gas classification labeling? Yes No
Regulator, hose and flexible connection
inspections? Yes No

29
Please explain: authorized area are constructed

for gas cylendr the opertor make segragaton for
every type in difinite area and tested by gas
detection instrument for lpg and H2
98 Has the facility developed and implemented bulk Not applicable Yes No NA
chemical handling procedures that include: Specific unloading and loading procedures? Yes Comments
No
Identification sampling before unloading? Yes
No
Hose inspection? Yes No
Fire protection? Yes No
Spill control measures (dike or bund area)? Yes
No Please explain:
99 Has the facility completed an evaluation to identify Yes No Yes No

processes or operations (exothermic reactions, the Please explain: two boilers used gasoline fuel Comments
use of flammable, combustible or toxic materials, fumagation by formaldhyde
and processes involving extreme temperatures or
pressures) that could present a significant safety,
health exposure, or environmental risk?
100 For operations and processes that handle highly Not applicable Yes No NA
hazardous chemicals and materials, (e.g. OSHA Process information requirements where the Comments
and/or SEVESO covered processes) has the site collection of process safety data, design
developed and implemented a process safety information, operating parameters, and
management program which includes: equipment specifications are documented? Yes
No
Are hazard evaluations completed that
adequately capture significant risks during
process development, preliminary engineering,
and upon completion of process design? Yes
No
Are the controls able to adequately mitigate the
risks identified in the process hazard
evaluations? Yes No
Has the site carried out hazardous area
classification including documentation (drawing)
and is the equipment appropriate for respective

30
zoning? Yes No
Have pressure vessels and relief devices been
sized to appropriate codes and standards? Yes
No
Pre-startup review program been established to
systematical review a process before new start
up and after management of change?
Yes No Please explain:
101 Does the facility assess the hazards (Minimum Yes No Yes No No
Ignition Energy, Kst classification rating, Impact Please explain: by use explosimetr and calculte Comments
sensitivity etc.) of the combustible dusts and the fire load of flammable matrials
powders they are handling?
102 For facilities that handle combustible powders, Grounding and bonding Yes No NA
what types of engineering controls are used to Explosion relief panels Comments
prevent explosions or damage to personnel, Damage limiting construction
equipment, or buildings?
Other
Please explain:
103 Does the facility have engineering controls in place Yes No Yes No
to provide a basis of safety (e.g. containment, Please explain: examples ?uses of explosive Comments
absence of a flammable atmosphere (vacuum or proof vacuum in certain area
inertion), suppression or venting)?
104 Does direct fire equipment (e. g. boiler, Yes No NA Yes No NA
incinerators, ovens etc.) have a burner Does it include: Comments
management and combustion control system Prevention of boiler feed water low level Yes
compliant with relevant insurance and/or regulatory No
requirements?
Routine testing in line with regulatory and/or
insurance requirements Yes No
105 Has the facility evaluated the impact of high hazard Yes No NA Yes No
operations on the community? Please explain: proof ? by assess the risk of all Comments
hazardous area
106 Has the facility evaluated the impact from high Yes No NA Yes No
hazard activities from neighboring operations that Please explain: Comments
may impact the site and result in business
interruption?
Emergency Preparedness and Response

31
107 Are the following areas of the facility equipped with Site areas Fire/smoke Sprinkler or Comments
fire detection/protection systems? detectors suppression
systems
Raw Yes No Yes No Yes No
material Under Comments
warehouse construction
Flammable Yes No Yes No Yes No
liquid Comments
storage
tanks
Process Yes No Yes No Yes No
areas Comments

Finished Yes No Yes No Yes No
product Comments
warehouse
108 Does the facility ensure that an adequate amount Yes No Yes No
of fire water is maintained for fire protection? Please explain and include the source of water: Comments
by drain monthly water came from city water
109 Are new facilities constructed of fire resistive or Yes No Yes No
non-combustible materials? Please explain: the company made new building Comments
according to egyptian code for fire
110 Are emergency exits and evacuation routes clearly Yes No Yes No
marked, kept free of obstructions (unlocked), and Please explain: the company have emergncy 4 Comments
illuminated with emergency backup power? genrators to supply the company by electric
power in case of network intruption
111 Are regular emergency evacuation drills Yes No Yes No

conducted, and what is the frequency? Frequency: 2 time annaully Comments
Please explain: SOP Number and
TitleEHS/O/011
112 Is the fire alarm system monitored 24 hours a day Yes No Yes No
(including weekends and holidays) with prompt Please explain: ADDRESSABLE alram system Comments
notification to emergency services (within 5 are present
minutes)?
113 Does the facility provide sufficient portable fire Yes No Yes No

32
extinguishing equipment for the hazards present? Please explain: number of fire extinguishing 450 Comments

114 Is the facility emergency response equipment (fire Yes No Yes No
extinguisher, fire pumps, sprinkler systems) Please explain: SOP Number and Title fire Comments
visually inspected monthly, comprehensively fighting EHS/O/003
inspected annually, and documentation maintained
for all inspections?
115 Does the facility properly store idle pallets Yes No NA Yes No
(e.g.limiting the number and height, no storage in Please explain: Comments
pallet racking, excess storage maintained outside

of the manufacturing facility/warehouse unless
proper fire suppression in place)?
116 Does the facility have a communication systems to Yes No NA Yes No
alert the local community of impacts in the event of Please explain what the communication system Comments
major emergency? consists of: according to procedure EHS/OP/010
117 Are emergency response plans in place and when Yes No NA Yes No NA
were the plans updated? When was the plan last updated: 2017 Comments

Have all foreseeable significant emergency Yes No NA
scenarios been accounted for in the Emergency Comments
Response Plan?
Yes No NA
118 Does the site have an on-site emergency response Yes No NA Yes No NA
team that is trained for fire or other emergencies? If yes, please explain: SOP EHS/O/002 Comments

119* Does the site use off-site consequence modeling to Yes No NA Yes No NA
evaluate to potential off-site impact of chemical If yes, please explain: SOP EHS/O/019 Comments
releases?

Hazard Information
120 Does the facility maintain Safety Data Sheets Yes No Yes No
(SDSs) for all hazardous substances? Please explain: SOP EHS/O/020 Comments

121 Does the facility have a training program covering Yes No Yes No
the properties and health effects of the hazardous Please explain: THE training programe are Comments
substances, use of and access to SDSs, container covered of aemployee on msds and R T K
labeling and safe handling procedures?

33
Biological Safety – Does the facility handle biological materials2 Yes No (skip this section) Auditor Verification
Please provide observations, details, comments and
122 Does the facility hold a regulatory Yes No Yes No NA
permit for biological material Please explain: Comments
operations?
123 Has the facility developed and Yes No Yes No NA
implemented a Biological Safety Please explain: UNDER CONSTRUCTION Comments
Program?
124 Does this program include procedures Yes No Yes No NA
to perform risk assessments of Please explain: according to EHS/OP/005 Comments
biological materials?
125 Does the facility have a bio-safety Yes No Yes No NA
committee responsible for evaluating Please explain: Comments
the risk associated with biological
materials operations and determining
control strategies?
126 Are engineering and/or administrative Administrative Controls Yes No Yes No NA
controls used to control employee Engineering Controls Yes No Comments
exposure to biological materials? Please explain: work done under laminar flow
127 Which of the following types of Human source material? Yes No NA
biological materials are stored or Yes No Specify RG: Comments
handled on the site (please specify the Non-human primate source material?
highest risk group (RG)3 or equivalent
Yes No Specify RG:
hazard category for each).
If yes please explain:
Bacteria? Yes No Specify RG:
If yes please explain: media standerd
Viruses? Yes No Specify RG:
2
Biological Materials include pathogenic and non-pathogenic microorganisms, proteins, and nucleic acids, as well as any biological matter that may contain
microorganisms, proteins, nucleic acids, or parts thereof. Examples include, but are not limited to, bacteria, viruses, fungi, prions, biological toxins, genetically modified
organisms, nucleic acids, tissue samples, biomedical waste, diagnostic specimens, live vaccines, and isolates of a pathogen (e.g., pure culture, suspension, and
purified spores).
3
As defined in the World Health Organization, Laboratory Biosafety Manual, 3rd Ed. (2004)

34

Fungi? Yes No Specify RG:
Genetically Modified Organisms / rDNA / recombinant
nucleic acid?
Yes No Specify RG:
Select Agents / Dual Use Agents (US only):
Yes No Specify RG:
Other (parasites, prions)?
Yes No Specify RG:
Biological toxins?
Yes No Specify RG:
If yes, is the LD50<10 ng/kg?
Yes No If yes please explain:

35
This section is to only be used by the auditor
Summary of Observations/Findings
Critical Findings
Finding PSCI Principle (Management Description of Finding Objective evidence observed Possible corrective action
number System/Ethics/Labor/Environment/Health
and Safety) and local law
(give regulatory citation)

Other Findings
Finding PSCI Principle (Management Description of Finding Objective evidence observed Possible corrective action
number System/Ethics/Labor/Environment/Health
and Safety) and local law
(give regulatory citation)

Note:
Critical Findings:
 High or very high risk observations that require immediate action to protect human life, the health of employees or the environment
 May result in loss of license to operate, damage to reputation
 Require immediate corrective action taken by supplier
 Need to be communicated to the audit sponsor prior to audit report finalization
Other Findings:
 Are all other major or minor audit findings, which need to be corrected by the supplier in an appropriate period of time

36
Summary of Points of Excellence / Good Examples observed
Points of Excellence / Good Examples observed Objective evidence observed


37
Photo Form
Adding Images To help keep the size of the Report as small as possible for ease of sending and saving the document we recommend that you use Microsoft Paint to
resize your photos. To do so please follow these instructions:
1) To start Microsoft Paint, click 'Start', 'Programs', 'Accessories', then 'Paint'.
2) Open the image file you wish to edit.
3) Click the 'Image' Menu at the top and select "Stretch/Skew Image”.
4) Choose a percentage figure to resize the image: to avoid distortion, choose the same percentage for horizontal and vertical stretch. Click OK.
5) Once you have the desired size, click File > Save As (to prevent overwriting the original image).
Save As jpeg (this provides compression to make the file smaller).
Insert Picture Insert Picture Insert Picture




38



39
Confirmation
Must be signed by both parties.
Please sign this document confirming that the above findings have been discussed with and understood by you: (site management)
Site Representative Signature: Name:
Title:
Date:
Auditor Signature: Name:
Title:
Date:
Please indicate below if you, the site management, dispute any of the findings
I dispute the following numbered findings:

Signed: Title
Date
Site Comments:



Full PSCI SAQ & Final

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Full PSCI SAQ & Final

Uploaded by

Copyright:

Available Formats

1

Pharmaceutical Supply Chain Initiative (PSCI)

AUDITOR AND AUDIT REPORT INFORMATION

DD/MM/YYYY Date and Type DD/MM/YYYY

Audit Firm Name:

Site Name (if different):

October 2016 Version 4

Parent Company Name

October 2016 Version 4

Attitude of workers (towards management, workplace, and the interview process):

Attitude of management (to audit and audit process):

Summary of main findings:

October 2016 Version 4

Facility Background Information

Other languages (spoken by at least 10% of the workforce):

October 2016 Version 4

Student workers (include students, apprentices and interns)

October 2016 Version 4

Legal and Customer Requirements

Please explain:

October 2016 Version 4

Please explain:according to OUTSOOURCING

October 2016 Version 4

Training and Competency

Please describe trainings in each of the following

October 2016 Version 4

18 Is there a company policy on giving Yes No Yes No

October 2016 Version 4

October 2016 Version 4

Please provide a web link to the policy on your web site, or

October 2016 Version 4

25 Does the facility ensure that Yes No Yes No

26 Does the facility disclose the Yes No Yes No

Child Labor and Young Workers

October 2016 Version 4

30 Does the facility ensure that Yes No Yes No

31 Does the facility ensure fair Yes No Yes No

Wages, Benefits, and Working Hours

34 Do employees have one full Yes No Yes No

October 2016 Version 4

employee not exceed 60 hours

38* Does the facility provide Yes No Yes No

October 2016 Version 4

October 2016 Version 4

Does the facility publicly report data?

Raw materials used for finished products

48 Do you send material to a region Yes No Yes No NA

October 2016 Version 4

Waste and Emissions

October 2016 Version 4

paper, wood, iron, metal,

October 2016 Version 4

55 Has the facility developed and Yes No Yes No

October 2016 Version 4

receiving the wastewater discharges to effectively perform treatment)

October 2016 Version 4

containment equivalent to at least

October 2016 Version 4

October 2016 Version 4

and wet areas? Yes No

72 Do safety symbols indicate the different hazards in Yes No NA Yes No NA

October 2016 Version 4