Carrier Check List (CX)

Air Carrier Audit Inspection Checklist
Carrier: Cathay Pacific Airways

Airport Location Code: CX
Ground Handling Subcontractor
name (if applicable): JAS

Date of Inspection:
Date of Report:
Report Completed by:
Carrier Representative:
28 October 2014
30 October 2014
Novrida Marlina
Glen Lisapaly
Comments
(Answer each element completely)
Key Areas (Minimal Requirement)

1. Air Carrier Security Program
Does the carrier have a security program in
place at the freight transfer locations?
Is access to freight controlled?
2. Branded Pharma Program
Does the carrier have a branded Pharma
Program
How long has the Pharma Program been
active.
Are SOPs in place for critical operations?
Does the program include handling
procedures for Semi Active and Active
containers (e.g. Envirotainer, PP360)?
3. Pest / Sanitation Control Program
Verify that a documented Pest / Sanitation
Control program is in place at the freight
transfer location.
Is MSDS information available along with
the listing of chemicals used with the
frequency of application?
Yes (details)
yes (use metal detector and body search for manual)
yes
2 years (since 2012)
Yes, Work Instruction for Pharmaceutical

handling , 03 november 2014, 1st edition , revision
1
yes
Yes, the latest control on 12 August 2014 by Rentokil

(the experts in pest control)
Yes, MSDS available (Brodifacoum for Big Rats,
Compliance
Rating
(QA ONLY)
Form # upsttqs0400-13
Effective Date 02-Jan-2014
Version 1.4
Unpublished Work Copyright 2013 by United Parcel Service of America, Inc. All Rights Reserved.
NOTE: This document is controlled when viewed on-line in the Integrated Document Management System. All other copies of this document are uncontrolled and should be verified against the
controlled copy prior to use.
Page 2 of 9
Comments

4. Document Control
Verify a record keeping system is in place
for all documents generated by the carrier
(i.e. temperature monitoring, movement
log, equipment maintenance, change
control, pest control, sanitation, deviation
investigation)
Verify if chain of custody documents
maintained to help the traceability of the
shipments. Electronic chain of custody
should be easily accessible.
5. Training Program
Does the company have on-going safety
and training programs?
Are job descriptions defined and
employees trained accordingly?
Are formal procedures for the Pharma
Program periodically being reviewed
and/or revised with signature approvals?
Are there training procedures for handling
Semi Active and Active containers (e.g.
Envirotainer, PP360) if not how are
handlers trained?
Are training records up-to-date to ensure
Yes, the maintanence kept this document in the office

Maintenance keep it for 1year (minimum)
Yes, they also update on the system (computer

record).
yes
yes
yes, Under specific Training on our Operational

training guidance section 3,4, and 5 no 27, with
training title Pharmaceutical Cold Chain
Management & Goods Distribution Practice (code
CP)
yes
yes
Compliance
Rating
(QA ONLY)
Version 1.4
Page 3 of 9
staff is trained on the updated procedures?
Version 1.4
Page 4 of 9
Comments

6. Investigation Program
Is there a deviation program in place to
investigate issues that may impact
transported products (temperature
excursions in transit, staging areas, etc.)?
Are preventative measures identified and
implemented to resolve deviations from
reoccurrence?
7. Temperature Conditioned Staging
Specify temperature conditioned staging
areas available:
2C-8C
15C-30C
20C-25C
< -10C
Other
What type of temperature monitoring?
Are temperature readings being
documented during staging / transit?
Are temperature conditioned staging areas
mapped, qualified or validated?
If qualified or validated is a test summary
document available?
Yes,
yes
o
o
o
o
o
Compliance
Rating
(QA ONLY)
Yes (Cool room)

Yes (Air Conditioned Room)
Yes (Air Conditioned Room)
Yes (Freezer Room)
Ambient (Using stick cone)
Thru monitor control (Honeywell), Logger building

automation system
No
No
No
Version 1.4
Page 5 of 9
Are alarm protocols in place?
Yes, reviewed
Comments

8. Calibration
Are temperature monitors located in
staging areas calibrated periodically and or
as recommended by the manufacturer?
Are calibration records available?
Is the calibration status displayed on the
yes
yes
yes, latest update on November 2014 and valid till
Compliance
Rating
(QA ONLY)
Version 1.4
Page 6 of 9
monitors?
9. Preventive Maintenance Program
Verify that a preventive maintenance
program is in place. The program should
include a listing of equipment (controlled
temperature staging areas etc.) along with
an associated frequency that the preventive
maintenance activity is to be completed.
Maintenance records are to include the
date, name of personnel performing
maintenance, equipment identification and
maintenance performed.
November 2015
yes
yes
Version 1.4
Page 7 of 9
Comments

10. Subcontracting
Are any services subcontracted?
If yes, what services are subcontracted?
Are subcontractors formally qualified?
Is there a contract or service level
agreement defining performance in place?
Is there a quality agreement in place?
Are subcontractors trained in managing
temperature sensitive material / shipments?
How are subcontractors trained in handling
Semi Active / Active containers?
Are subcontractors audited? How is their
performance evaluated?
11. Quality Audits
Verify if there is a quality manual or quality
policy in place.
Verify if internal audits are performed.
Are non-conformance observations being
followed up?
Have you been audited by any government
regulatory body? If yes, by whom and
when?
Yes
Calibrate temperature/ Clean the room
Yes
Yes, it is reviewed annually or based on contract
agreement.
Yes
Yes
Based on IATA PCR Table 17.11.A for technical

support
Yes (once annually for calibration/ daily for cleaner)
Yes, Quality Manual for Pharmaceutical handling, 1st

edition, revision 00, dated 27 october 2014
yes
yes
Compliance
Rating
(QA ONLY)
yes, by IATA once in 2 year, Dishub (DGAC)

randomly, Airport Authority annually and randomly
Version 1.4
Page 8 of 9
Overall Results:
Acceptance criteria:The compliance rating is derived from the audit findings (Critical, Major, Minor).
Critical: An observation whereby practices or processes will adversely affect the quality or integrity of product
shipments and which cannot be mitigated by other procedures or systems in place. Example: Fraud
Major: An observation whereby practices or processes might adversely affect the quality or integrity of the
product shipments but may be mitigated by other procedures or systems in place.
Minor: An observation whereby conditions, practices, or processes that is that is neither Critical nor Major but
may pose a negligible risk to the product shipments and may be mitigated by other procedures or systems in
place. Observations classified as minor indicate the need to improve conditions, practices, or processes.
Example(s) include: Temperature mapping in a certain location not completed, No documentation available to
show maintenance performed according to manufacturers specs., PM not performed as scheduled, Version no.
not indicated on training records, daily checks not documented, no supervisor sign offs, documents not dated
and initialed.
Response: Within 30 business days of receiving the inspection report, a report/action plan should be written addressing the issues of
the audit by the date specified on page 1 of this report. This plan will provide an update of current status and planned
actions with completion dates (Resolution of Self-Audit).
Audit by: _______________________________________
(Print and signature)
QA Review: _____________________________________
Date: _____________________
Date: _____________________
Version 1.4
Page 9 of 9
Version 1.4

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Carrier Check List (CX)

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Air Carrier Audit Inspection Checklist

Carrier: Cathay Pacific Airways

Ground Handling Subcontractor

name (if applicable): JAS

Key Areas (Minimal Requirement)

yes (use metal detector and body search for manual)

2 years (since 2012)

Yes, Work Instruction for Pharmaceutical

Yes, the latest control on 12 August 2014 by Rentokil

Yes, MSDS available (Brodifacoum for Big Rats,

Key Areas (Minimal Requirement)

Yes, the maintanence kept this document in the office

Yes, they also update on the system (computer

yes, Under specific Training on our Operational

staff is trained on the updated procedures?

Key Areas (Minimal Requirement)

Yes (Cool room)

Thru monitor control (Honeywell), Logger building

Are alarm protocols in place?

Key Areas (Minimal Requirement)

Key Areas (Minimal Requirement)

Based on IATA PCR Table 17.11.A for technical

Yes (once annually for calibration/ daily for cleaner)

Yes, Quality Manual for Pharmaceutical handling, 1st

yes, by IATA once in 2 year, Dishub (DGAC)

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