Transport services & quality questionnaire for GDP

Pre-amble & scope

The questionnaire needs to be completed in order to make an assessment if the transport company is compliant with the current GDP (Good
Distribution Practices) guideline and requirements of H.Essers.
The service under audit is transportation of pharmaceutical products.

Company information
Company Name
JanouTransport
Address
Quartier Founty, Agadir Technopole bloc A, 2ème étage, bur 211, Agadir
Business contact (name, phone, mail)
Omar El Ghazoini E-mail:el.omar@janoutransport.com Tel: +212 661-820153
Quality contact (name, phone, mail)
Fatima El Machbouk E-mail: service_qualite@janoutransport.com Tel: +212 7031-06020

Questionnaire completed by
Name
Fatima El Machbouk
Function
Responsable qualité
Date
12/01/2023

Signature

(please also sign each page of the questionnaire)

1. Quality management

Score
Item Question Yes No N/A Additional info / Comments
(Essers)

Is your company ISO9001 certified? Which other

quality certificates do you have?
1.1 x

Please add a copy of the certificate(s)

Are all processes within the company in accordance

1.2 X
with the cGDP guidelines?

Has an internal audit and self-inspection program,

covering all aspects of GDP, been implemented and
1.3 X
are all the observations of the inspections recorded
and reported?

Is a change control (not version control) system in

1.4 X
place?

Are quality risk management principles incorporated

1.5 X
in the change control system?

Are management responsibilities clearly specified? X

1.6

If yes, where? complete, please ORGANIZATIONAL CHART + PROCESS PROCEDURES + JOB DESCIPTION

Is the quality system regularly reviewed and is the

achievement of objectives checked by the X
management?
1.7
Mountly Combine with other bussiness activities,strategic
What is the frequency of management reviews? complete, please
planings,operation meetings, custommer requirements.

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 Transport services & quality questionnaire for GDP

2. Personnel

Score
Item Question Yes No N/A Additional info / Comments
(Essers)

Is an organizational chart available?

2.1 X

Please add a copy

Has a responsible person for GDP been assigned?

2.2 X
Who?

Are written job descriptions for every function profile

2.3 X
available?

Are all drivers on your own payroll (not employed by a

2.4 X
third party)?

Are the principles of the cGDP requirements part of

2.5 X WE PLAN TO PREPARE A PROGRAM FOR GDP PRINCIPALS
the training program of all employees?

Is a written training program and procedure for all

2.6 X
personnel available?

2.7 What is the frequency of these trainings? complete, please EACH 6 MOUNTS

Are trainings recorded and is the effectiveness

2.8 X
assessed and monitored?

In your driver selection procedure, what do you check

To selection our drivers we check his legal back ground and his
2.9 and how do you document this? (good behaviour, complete, please
experience in Transport of goods and the driving Iternational licence.
background, …)

Is a driver’s manual in place and distributed to all

2.10 X
drivers?

Does this contain actions to be taken in an emergency

2.10.1 x
and security measures?

Does this contain inspection instructions prior to

loading: functioning of the refrigeration unit and
2.10.2 x
temperature printing device, cleanliness of trailer
compartment, fuel level…?

Does this contain (un)loading instruction: stowage and

2.10.3 x
load securing, presence during (un)loading…?

3. Computerized systems

Score
Item Question Yes No N/A Additional info / Comments
(Essers)

Are all computers and systems protected from Yes all personnel has an own passewords and we have a system of
3.1 x
unauthorized access? How? protection Antivirus.

3.2 Are back-ups made? x

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 Transport services & quality questionnaire for GDP

3.2.1 How often are back-ups made? complete, please TWICE A DAY

How long are back-ups stored?

3.2.2 complete, please 20 years
H.Essers requires 15 years.

Is a procedure in place that describes what has to be

3.3 done in case of system failure or break down and how x
data can be restored?
Has a validation or verification of the system been
done to demonstrate that the system is capable of
3.4 x
achieving the desired results accurately, consistently
and reproducibly?

4. Documentation

Score
Item Question Yes No N/A Additional info / Comments
(Essers)

Are all procedures and instructions documented on

4.1 paper or in electronic form and in a language x
understood by personnel?

How long are these documents retained? H.Essers

4.2 complete, please 20 years
requires 15 years.

4.3 How frequently are documents reviewed? complete, please annually

Are deviations from procedures documented and

4.4 x
investigated?

Is version control applied to procedures and

4.5 x
instructions?

5. Complaint / deviation handling

Score
Item Question Yes No N/A Additional info / Comments
(Essers)

Do (will) you always notify H.Essers of deviations

5.1 x
(temperature and other problems)?

How do (will) you report deviations pro-actively to

5.1.1 complete, please by call or sending an emails
H.Essers?

What is the timeframe within which you report a

5.1.2 complete, please 30 min or 1 hour after deviations
deviation?

Is every deviation investigated to identify the origin of

5.1.3 x
or reason for the deviation?

Are the three topics above described in a written

5.1.4 x
procedure?

5.2 Are all customer complaints logged? x

Is every complaint investigated to identify the origin of

5.2.1 x
the complaint and actions taken?

What is the timeframe within which you inform the

5.2.2 complete, please three to seven days
customer of the investigation?

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 Transport services & quality questionnaire for GDP

Are the two topics above described in a written

5.2.3 x
procedure?

5.4 Are CAPA’s taken and managed when necessary? x

5.5 Is a person appointed to handle all complaints? Who? x Quality manager

Do you keep a detailed log of deviations, complaints

5.6 and CAPA's and is this used to evaluate your own x
performance through periodic KPI's?

6. Transportation equipment

Score
Item Question Yes No N/A Additional info / Comments
(Essers)

The maximum allowed age for trailers is 12 years and

6.1 x 5 YEARS FOR TRAILRS+ 5 YEARSF FOR VANS
for vans 6 years. Can you confirm?

Is an operating manual for the cooling unit available in

6.2 x
each vehicle?

Do you have a documented program/schedule for

6.3 preventive maintenance of the vehicle/trailer, incl. x
cooling unit?

6.4 What is the frequency of these inspections? complete, please QUARTERLY

Are maintenance records archived? How long?

6.5 x 20 years
H.Essers requires 15 years.

Do you have a 24/7 service contract for your

6.6 temperature controlled vehicles, in case of technical x Carrier and sofrial
breakdown?

Are vehicles/trailers only used to transport

6.7 x
pharmaceuticals?

If not, what do you do to avoid the risk of

For avoiding the risk of contamination we programmed a manuel for
6.7.1 contamination between the unloading of a non- complete, please
desinfection of unit cooling before loading the pharmaceutical product.
pharma and loading of a pharma transport?

If not, can you guarantee that there is no co-loading

6.7.2 with non-compatible (non-pharma) products to avoid x
contamination?

Is the inside of the trailers cleaned at regular intervals?

6.8 x regulary and routinely
How often?

Are cleaning records kept? How long? H.Essers

6.9 x
requires 15 years.

6.10 Is the calibration process described in a procedure? x we do the calibration externally in a specific firm approved

Have you performed a temperature mapping study of

6.11 your vehicles under representative summer and x
winter conditions?

Are trailers ATP-FRC certified?

Are your vans at least ATP-FNA certified?
6.12 x
Please add 2 examples of an ATP
certificate.
Are all vehicles equipped with a printer to provide
6.13 temperature information of the shipment upon pick- x
up and delivery?

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 Transport services & quality questionnaire for GDP

Are PRINTER temperature sensors calibrated, and if so

how often?
6.13.1 x annualy
Please add two PRINTER sensor
calibration certificates.

Do temperature tickets mention the license plate of

6.13.2 x
the vehicle?

What is the time setting of the printer?

6.13.3 complete, please
GMT, GMT+1, GMT+2, …?

Are vehicles equipped with GPRS for real-time

6.14 x 85% of the véhicules
temperature follow-up?

Are GPRS temperature sensors calibrated, and if so

how often?
6.14.1 x
Please add two GPRS sensor calibration
certificates.

Does this system allow for temperature reports to be

6.14.2 x
generated?

What is the name of the telematics system used in

6.14.3 complete, please Gps
your organization?

Do vehicles generate an alarm to notify in case of

6.14.4 x
temperature excursions?

6.14.5 Who receives these alarms and how? complete, please the operators follow temperature by GPS

We are working for more security of our trailers but the GPS shows
6.15 Are vehicles equipped with door opening alarms? x
when the door opens

Does this generate an audible alarm (siren) to notify

6.15.1 X
the driver?

6.15.2 Does this generate a notification to the dispatcher? X

6.15.3 Is this visible on GPRS reports from the vehicle? X

7. Transport criteria and supply chain management

Score
Item Question Yes No N/A Additional info / Comments
(Essers)

Does your company have operating licences consistent

with the activities and operations?
7.1 x
Please add a copy of your
transportation license

Can your company guarantee working/driving hour

7.2 x
compliance and do you keep records?

7.3 Do your drivers hold valid ADR licences? x

Are orders managed in a Transport Management

7.4 x
System? If not, how are orders handled?

Is a written, detailed description of the system

7.5 X
available?

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 Transport services & quality questionnaire for GDP

How does the dispatch department communicate

relevant information and instructions to the driver
7.6 complete, please by calling
(including route criteria, consignor/consignee details,
temperature details, customer instructions…)?

How do you follow your vehicles throughout the

7.7 complete, please by GPS and the follow-up with drivers
complete process from loading until unloading?

Are actual (un)loading date, time and location

7.8 X
registered and confirmed to the customer?

Is your company willing to use H.Essers’ online

7.9 Track&Trace application to confirm loading & X
unloading, and upload POD’s & temperature tickets?

Can your company make sure transports of

7.10 pharmaceutical products are not subcontracted to a X
third party?

How long are POD’s and temperature tickets archived?

7.11 complete, please 10 years with H.Essers we can archived the tickets 20 years
H.Essers requires 15 years.

8. Insurance requirments

Carrier's liability insurance / CMR insurance

What is the policy limit of your carrier's liability
insurance (CMR liability insurance)? complete, please
H.Essers requires minimum €350K.

Please confirm your insurance policy does not exclude

x
pharmaceutical products or drugs?

8.1 Does your policy also provide cover in case of Article

29 of the CMR convention (gross negligence or willful x
misconduct)?
What is the sublimit for these cases?
H.Essers requires minimum €1Mio for trailers and €500K for complete, please we can increase the insurance in case of request
vans.

Please add copy of insurance policy

Does your company have an insurance of property

owned or used, such as rolling equipment and cross-
x
dock facilities, against material damage, and at least
8.2 the risk of fire, water damage and theft

Please add copy of insurance policy

Third Party Motor liability insurance

Does your company have a third party motor liability
insurance for the vehicles deployed in accordance to X
applicable statutory laws and within statutory limits?
What is the policy limit of your TPML insurance (bodily
injury, material damage and immaterial damage
complete, please
combined)?
H.Essers requires a minimum of €2,5Mio
8.3
Is environmental pollution insured? x 90% of our vehicule are of type EURO6

In case you tow H.Essers trailers, does your TPML

insurance inlude a waiver of recourse towards x
H.Essers?

Please add copy of insurance policy

Commercial General liability insurance

Does your company have commercial general liability
insurance for bodily injury, material and immaterial x
damage and loss?

8.4
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 Transport services & quality questionnaire for GDP

What is the policy limit of your commercial general

8.4 liability insurance (bodily injury, material and
complete, please Janoutransport can increase it in case of request
immaterial damage and loss combined?)
H.Essers requires a minimum of €1,25Mio

Please add copy of insurance policy

Trailer / Container liability insurance

In case you tow H.Essers trailers, do you have a trailer
x
/ container liability insurance?

If so, is this a stand-alone insurance, or is it part af

complete, please
another policy? Which policy?
8.5
What is the policy (sub)limit of your trailer / container
liability insurance? complete, please
H.Essers requires a minimum of €750K

Please add copy of insurance policy

Workmen's compensation (employer's liability) insurance

Does your company have a workmen’s compensation

insurance in accordance to applicable statutory laws?
In case no obligation for such workmen’s
compensation applies, the Carrier will have an
X CNSS
occupational accident insurance or an employer’s
8.6
liability insurance for a limit not less than 1.000.000
Euros. This insurance shall contain a waiver of
recourse in favour of Client.

Please add copy of insurance policy

9. Security

Score
Item Question Yes No N/A Additional info / Comments
(Essers)

Are both vehicles (truck and trailer) and goods

x
sufficiently protected to prevent theft?
9.1
How is the trailer locked to prevent unauthorized all unauthorized access to vehicle levels is imported into the gps
complete, please
access? What type (brand) of locks are being used? software

In case where you operate small vehicles / vans, can

x
these be locked and sealed?
9.2
How is the cargo area locked to prevent unauthorized All the warehouse is also the MEAD area contains surveillance cameras
complete, please
access? What type (brand) of locks are being used? and 24/7 guarding

Is a written plan in place for dealing with off-site

9.3 emergencies (covering a list of parties to be informed, x
arrangements for 24/7 coverage)?

Do you have a formal agreement with an external

9.4 x
emergency response company in case of vehicle theft?

Does each crew member of a vehicle carry with them

9.5 means of identification, which shows their x ID CARD+Driving licence+visa
photograph? Which ones?

Can drivers be contacted 24/7 in case of emergency?

9.6 x Whatsapp numbers
How?

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 Transport services & quality questionnaire for GDP

To be completed by H. Essers:

Review Conclusion

Name Score …/ = %

Status carrier (strike

Function
what is not applicable) Sufficient / Insufficient

Date

If insufficient, state
reason(s):

Signature

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