Full PSCI SAQ & Final
Full PSCI SAQ & Final
Full PSCI SAQ & Final
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.
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.
Note: do not document information that could put the worker at risk
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:
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
MANAGEMENT SYSTEMS Self-Assessment Questionnaire - Questions marked with an asterisk (*) are Auditor Verification
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)
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
any supporting documents
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
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:
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
any supporting documents
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
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
any supporting documents
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
Other
Yes No NA
Please explain:
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)
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
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
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?
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:
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,
Comments:
71 Has the facility developed and implemented Yes No NA Yes No NA
machine guarding procedures? Comments: Comments
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.)?
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
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
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:
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
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
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?
Biological Safety – Does the facility handle biological materials2 Yes No (skip this section) Auditor Verification
Please provide observations, details, comments and
any supporting documents
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)
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
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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)
Title:
Date:
Title:
Date:
Please indicate below if you, the site management, dispute any of the findings
I dispute the following numbered findings:
Date
Site Comments: