EASA Part 145 Quality System Audit (Performance)

Name Of Auditee

Date of Audit

Name of Auditor

Audit Standard EASA Part 145 IR, AMC & GM

Additional Guidance is shown in Bold Italics – Basic Questions include

Management & Oversight –Ownership of Procedures - Competence &
Training “as required” Completeness, Compliance & Validity of Procedures.
In all cases identify the reference of MOE and Associated Procedure

Point 145.A.65 (c) requires that the quality system monitors that the activities are
being performed in accordance with the approved procedures. The quality system
procedures are included within these approved procedures. This implies that
quality system must be subject to audits and the part-145 organisation audit
programme/plan needs to reflect this.

Besides that the audits of the quality system shall satisfy the requirement of
independent audits. This is further explained in AMC 145.A.65(c)(1) point 11: the
independence of the audits should be established by always ensuring that audits
are carried out by personnel not responsible for the functions, procedures or
products being checked.

So, the quality manager cannot audit the quality system in terms of independence
of the audit.

Therefore, to audit the quality system, it is acceptable to:

Use competent personnel from a different section/department in the same

organisation not responsible for the quality function/procedure, or,

Contract the independent audit element of the quality system to another

organisation or a qualified competent person, or,

Have the quality system is monitored and certified against an internationally

recognised quality standards by a certification organisation.

Audit Criteria Compliant Y or N – Provide MOE

/Associated Procedure Reference
for Compliance or detail Corrective
Action Request & Reference
The way the quality system is going to be
audited has to be described in the MOE
and approved by the competent authority.
AMC1 145.A.30(e) Personnel
requirements Quality audit staff are able to
monitor compliance with Part-145
identifying noncompliance in an
effective and timely manner so that the
organisation may remain in compliance
with Part-145.

AMC 145.A.30(c) Personnel requirements

Monitoring the quality system includes
requesting remedial action as necessary
by the accountable manager and the
nominated persons referred to in
145.A.30(b).

GM2 145.A.30(e) Competence

assessment procedure

The Following elements form the basis of

the expectations for a Quality Assurance
Professional within the EASA Part 145
Organisation

For each relevant item shown below

reference how this element is
demonstrated

Knowledge of applicable officially

recognised standards

Knowledge of auditing techniques:

planning, conducting and reporting

Knowledge of human factors, human

performance and limitations

Knowledge of organisation capabilities,

privileges and limitations

Knowledge of Part-M, Part-145 and any

other relevant regulation

Knowledge of relevant parts of the

maintenance organisation exposition and
procedures

Knowledge of safety risks linked to the

working environment
Knowledge on CDCCL when relevant

Knowledge on EWIS when relevant

Understanding of professional integrity,

behaviour and attitude towards safety

Understanding of conditions for ensuring

continuing airworthiness of aircraft and
components

Understanding of his/her own human

performance and limitations

Understanding of personnel authorisations

and limitations

Understanding critical maintenance task

Ability to identify and rectify existing and
potential unsafe conditions

Ability to understand work orders, work

cards and refer to and use applicable
maintenance data

Ability to use information systems

Adequate communication and literacy skills

Analytical and proven auditing skills (for

example, objectivity, fairness, open-
mindedness, determination, …)

Maintenance error investigation skills

145.A.65 Safety and quality policy,

maintenance procedures and quality
system

(a) The organisation shall establish a

safety and quality policy for the
organisation to be included in
the exposition under point 145.A.70.

(b) The organisation shall establish

procedures agreed by the competent
authority taking into account human factors
and human performance to ensure good
maintenance practices and compliance
with the applicable requirements
established in 145.A.25 to 145.A.95.

The procedures under this point

shall:

1. ensure that a clear work order or

contract has been agreed between the
organisation and the organisation
requesting maintenance to clearly
establish the maintenance to be carried out
so that aircraft and components may be
released to service in accordance with
145.A.50; and,

2. cover all aspects of carrying out

maintenance, including the provision and
control of specialised services and lay
down the standards to which the
organisation intends to work.

(c) The organisation shall establish a

quality system that includes the following:

1. Independent audits in order to monitor

compliance with required aircraft/aircraft
component standards and adequacy of the
procedures to ensure that such procedures
invoke good maintenance practices and
airworthy aircraft/aircraft components.

In the smallest organisations the

independent audit part of the quality
system may be contracted to another
organisation approved under this Part or a
person with appropriate technical
knowledge and proven satisfactory audit
experience; and

2. A quality feedback reporting system to

the person or group of persons specified in
point 145.A.30(b) and ultimately to the
accountable manager that ensures proper
and timely corrective action is taken
in response to reports resulting from the
independent audits established to meet
point (1). AMC 145.A.65(a) Safety and
quality policy, maintenance procedures
and quality system.
The safety and quality policy should as a
minimum include a statement committing
the organisation to:

Recognise safety as a prime consideration

at all times.

Apply Human factors principles.

Encourage personnel to report

maintenance related errors/incidents.

Recognise that compliance with

procedures, quality standards, safety
standards and regulations is the
duty of all personnel.

Recognise the need for all personnel to

cooperate with the quality auditors.

AMC 145.A.65(b) Safety and quality policy,

maintenance procedures and quality
system

1. Maintenance procedures should be held

current such that they reflect best practice
within the organisation.

It is the responsibility of all organisation’s

employees to report any differences via
their organisation’s internal occurrence
reporting mechanisms.

2. All procedures, and changes to those

procedures, should be verified and
validated before use where practicable.

3. All technical procedures should be

designed and presented in accordance
with good human factors principles.

GM 145.A.65(b)(1) Safety and quality

policy, maintenance procedures and
quality system Appendix XI to AMC
M.A.708(c) provides guidance on the
elements that need to be considered for
the maintenance contract between the
CAMO and the maintenance organisation.
The Part-145 organisation should take into
account these elements to ensure that a
clear contract or work order has been
concluded before providing maintenance
services.

AMC 145.A.65(b)(2) Safety and quality

policy, maintenance procedures and
quality system Specialised services include
any specialised activity, such as, but not
limited to non-destructive testing requiring
particular skills and/or qualification.

145.A.30(f) covers the qualification of

personnel but, in addition, there is a need
to establish maintenance procedures that
cover the control of any specialised
process.

AMC 145.A.65(c)(1) Safety and quality

policy, maintenance procedures and
quality system

1. The primary objectives of the quality

system are to enable the organisation to
ensure that it can deliver a safe product
and that organisation remains in
compliance with the requirements.

2. An essential element of the quality

system is the independent audit.

3. The independent audit is an objective

process of routine sample checks of all
aspects of the organisation’s ability to carry
out all maintenance to the required
standards and includes some product
sampling as this is the end result of the
maintenance process.

It represents an objective overview of the

complete maintenance related activities
and is intended to complement the
145.A.50(a) requirement for certifying staff
to be satisfied that all required
maintenance has been properly carried out
before issue of the certificate of release to
service.
Independent audits should include a
percentage of random audits carried out on
a sample basis when maintenance is being
carried out.

This means some audits during the night

for those organisations that work at night.

4. Except as specified in sub-paragraphs 7

and 9, the independent audit should
ensure that all aspects of Part-145
compliance are checked every 12 months
and may be carried out as a complete
single exercise or subdivided over the 12
month period in accordance with a
scheduled plan.

The independent audit does not require

each procedure to be checked against
each product line when it can be shown
that the particular procedure is common to
more than one product line and the
procedure has been checked every 12
months without resultant findings.

Where findings have been identified, the

particular procedure should be rechecked
against other product lines until the
findings have been rectified after which the
independent audit procedure may revert
back to 12 monthly for the particular
procedure.

5. Except as specified otherwise in

subparagraphs 7, the independent audit
should sample check one product on each
product line every 12 months as a
demonstration of the effectiveness of
maintenance procedures compliance.

It is recommended that procedures and

product audits be combined by
selecting a specific product example, such
as an aircraft or engine or instrument and
sample checking all the procedures and
requirements associated with the specific
product example to ensure that the end
result should be an airworthy product.
For the purpose of the independent audit,
a product line includes any product under
an Appendix II approval class rating as
specified in the approval schedule issued
to the particular organisation.

It therefore follows for example that a

maintenance organisation approved under
Part-145 with a capability to maintain
aircraft, repair engines, brakes and
autopilots would need to carry out four
complete audit sample checks each year
except as specified otherwise in
subparagraphs 5, 7 or 9.

6. The sample check of a product means

to witness any relevant testing and visually
inspect the product and associated
documentation. The sample check should
not involve repeat disassembly or testing
unless the sample check identifies findings
requiring such action.

7. Except as specified otherwise in sub-

paragraph 9, where the smallest
organisation, that is an organisation with a
maximum of 10 personnel actively
engaged in maintenance, chooses to
contract the independent audit element of
the quality system in accordance with
145.A.65(c)(1) it is conditional on the audit
being carried out twice in every 12 month
period.

8. Except as specified otherwise in sub-

paragraph 9, where the organisation has
line stations listed as per 145.A.75(d) the
quality system should describe how these
are integrated into the system and include
a plan to audit each listed line station at a
frequency consistent with the extent of
flight activity at the particular line station.
Except as specified otherwise in sub-
paragraph 9 the maximum period between
audits of a particular line station should not
exceed 24 months.

9. Except as specified otherwise in sub-

paragraph 5, the competent authority may
agree to increase any of the audit time
periods specified in this AMC
145.A.65(c)(1) by up to 100% provided that
there are no safety related findings and
subject to being satisfied that the
organisation has a good record of
rectifying findings in a timely manner.

10. A report should be raised each time an

audit is carried out describing what was
checked and the resulting findings against
applicable requirements, procedures and
products.

11. The independence of the audit should

be established by always ensuring that
audits are carried out by personnel not
responsible for the function, procedure or
products being checked.

It therefore follows that a large

maintenance organisation approved under
Part-145, being an organisation with more
than about 500 maintenance staff should
have a dedicated quality audit group
whose sole function is to conduct audits,
raise finding reports and follow up to check
that findings are being
rectified.

For the medium sized maintenance

organisation approved under Part-145,
being an organisation with less than about
500 maintenance staff, it is acceptable to
use competent personnel from one section
/department not responsible for the
production function, procedure or product
to audit the section/department that is
responsible subject to the overall planning
and implementation being under the
control of the quality manager.

Organisations with a maximum of 10

maintenance staff actively engaged in
carrying out maintenance may contract the
independent audit element of the quality
system to another organisation or a
qualified and competent person approved
by the
competent authority. GM 145.A.65(c)(1)
Safety and quality policy, maintenance
procedures and quality system

1. The purpose of this GM is to give

guidance on just one acceptable working
audit plan to meet part of the needs of
145.A.65(c)1. There is any number of other
acceptable working audit plans.

2. The proposed plan lists the subject

matter that should be covered by the audit
and attempts to indicate applicability in the
various types of workshops and aircraft
facilities.

The list should therefore be tailored for the

particular situation and more than one list
may be necessary.

Each list should be shown against a

timetable to indicate when the particular
item is scheduled for audit and when the
audit was completed.

AMC 145.A.65(c)(2) Safety and quality

policy, maintenance procedures and
quality system

1. An essential element of the quality

system is the quality feedback system.

2. The quality feedback system may not be

contracted to outside persons.

The principal function of the quality

feedback system is to ensure that all
findings resulting from the independent
quality audits of the organisation are
properly investigated and corrected in a
timely manner and to enable the
accountable manager to be kept informed
of any safety issues and the extent of
compliance with
Part-145.

3. The independent quality audit reports

referenced in AMC 145.A.65(c)(1) sub-
paragraph 10 should be sent to the
relevant department(s) for rectification
action giving target rectification dates.

Rectification dates should be discussed

with such department(s) before the quality
department or nominated quality auditor
confirms such dates in the report.

The relevant department(s) are required by

145.A.65(c)(2) to rectify findings and
inform the quality department or nominated
quality auditor of such rectification.

4. The accountable manager should hold

regular meetings with staff to check
progress on rectification except that in the
large organisations such meetings may be
delegated on a day to day basis to the
quality manager subject to the accountable
manager meeting at least twice per year
with the senior staff involved to review the
overall performance and receiving at least
a half yearly summary report on findings of
non-compliance.

5. All records pertaining to the independent

quality audit and the quality feedback
system should be retained for at least 2
years after the date of clearance of the
finding to which they refer or for such
periods as to support changes to the AMC
145.A.65(c)(1) sub-paragraph 9 audit time
periods, whichever is the longer.

Guidance Notes Concerning PART 3 –

QUALITY SYSTEM PROCEDURES.

3.1 Quality Audit of Organisation

Procedures.

Part 145.A.65 (a) - Part 145.A.65 (c) (1),

(2) / AMC 145.A.65 (c) (1)

This chapter must explain how the audit of

internal procedures is organised and
managed i.a.w. PART 145.A.65 and AMC
145.A.65.
In particular this chapter shall describe
how the requirements for
system/procedure audit are complied with
and the methodology of the audit.

Small organisation may choose to

subcontract the audits to another
organisation or an outside person with
satisfactory technical knowledge and
satisfactory audit experience (link to
chapter 3.6).

Definition of the Quality System:

Independence of the quality compliance

monitoring staff (e.g. quality auditor)

Access to Accountable Manager

Composition and functions of management
quality group

Definition of the “system/procedure” audit

(ref. AMC 145.A.65 (c).(1).3&4)16

Common audit procedures for several lines

of product

Specific audit procedure by line of product

Single exercise audit or subdivided over 12

months

Findings classification (ref. 145.A.95)

Procedures to manage findings and related

due dates to be entered in MOE chapter

3.3 “System/procedure” Audit programme

System/procedure audit plan (refer to GM

145.A.65.(c).(1))

Principles of annual audit procedure

planning

Grouping of audits

Dates and timescales.

Audit of the Quality system by an
independent auditor, being either:

A person employed by the maintenance

organisation and working in another
department (i.e. production), or;

A person contracted by the maintenance

organisation (part-time basis or short time
contract based on the 145.A.30 (d)
contracted personnel) to perform audits on
the quality system procedures.

This case does not mean subcontracting

the quality system.

Audit of contracted organisations

/Subcontractors/suppliers, as applicable
depending to the monitoring criteria
defined in MOE chapter 2.1.

Scheduled audits and audits to be carried

out at random and to be carried out during
maintenance including night shifts.

Validation/internal approval of the audit

programme and management of changes
to the programme Follow up of the audit
program: scheduled, performed, audit
report issued, open/close – link with
chapter 3.3

Company Audit Policy including

compliance audit:

The internal audit plan shall also take into

account the applicable Part-M
requirements
Part-145 organisations shall take into
account the following requirements of Part-
M:

M.A.201 (c) – Responsibilities

M.A.402 (a) & (f) – Performance of
Maintenance;
M.A.403 (b) – Aircraft defects
M.A.501 (a) & (c) & (d) – Installation
M.A.504 (a) & (b) & (d) & (e) – Control of
unserviceable components
In addition, Part-145 refers to the following
Appendixes of Part-M:
Appendix II to Part-M (EASA Form 1)
Appendix IV to Part-M (Class and rating
system)
Appendix IX to AMC M.A.602 and AMC
M.A.702 (EASA Form 2)
Appendix X to AMC M.B.602(a) and AMC
M.B.702(a) (EASA Form 4)

The MOE shall be customised by each

organisation to demonstrate how they
comply with:
For each detailed procedure described
within the MOE, the Part 145 organisation
should address the following questions:

What must be done?

Who should do it?
When must be done?
Where must it be done?
How must it be done?
Which procedure(s)/form(s) should be
used?

Consider the following elements

Audit notification;

Audit reports (documents used, writer,

issue, points checked and deviations
noted, deadline for rectification)

Reference can be made to MOE chapter

3.3 detailing the process to manage
findings

Allocation of resources to the audit (audit

team, team leader, etc.)

Principles when deviations are noted on a

line of product Quality audit reports
retention

Duration (At least duration of 2 years from

the date of the findings closure) / location
Type of documents (notification, audit
reports, check list, audit programs)
3.2 Quality Audit of Aircraft and/or
Components.
Part 145.A.65 (c) (1), (2) / AMC 145.A.65
(c) (1)

This chapter must describe the procedures

related to the product audits (aircraft,
aircraft component, engine, specialised
service) according to PART 145.A.65 (c) 1
and AMC 145.A.65 (c).

Definition of “Product” audit (ref. AMC

145.A.65.(c).(1).5Company “Product” Audit
Policy

A dedicated “Product” audit policy may be

added, provided it does not conflict with
the one describe in the previous chapter.

The Company audit procedure shall

include the quality audit of aircraft (and/or
component)

“Product” Audit programme

Product samples for each line of product

(aircraft and / or components and/or
engines and/or specialised services)

Dates and timescales

“Product” Auditing methods

Sampling

"Trail" / “investigation” audits

Records of “Product” audit reports

Duration (At least duration of 2 years from

the date of the findings closure) / location
Type of documents (notification, audit
reports, check list, audit programs,

Small organisation may choose to

subcontract the audits to another
organisation or an outside person with
satisfactory technical knowledge and
satisfactory audit experience (link to
chapter 3.6).
Quality Audit Corrective Action Procedure.

Part 145.A.65 (c) (2) / AMC 145.A.65 (c)

(2)

This chapter must describe the procedures

of follow up of corrective actions.

Description of the quality audit report

feedback system

Corrective action and timescale

Corrective action planning and follow up

e.g notified, answered, corrective action
accepted,

open/closed

The corrective action plan shall be

designed in a way which allows identifying
and recording the finding, the root cause,
the relevant immediate and long term
preventive action with the appropriate
timescales.

Management of finding due dates

Alert system, finding database

Extension of the due date Procedure

describing the organisation actions when
the corrective action deadline has to be
postponed or when the answer has not
been received on time.

Management responsibilities for corrective

action and follow-up Review of the

Quality system overall results Meeting with

the Accountable Manager. (including
record of meeting procedure)

Regular meetings to check the progress of

corrective actions

The follow up of corrective actions cannot

be subcontracted.
The revision of the audit planning
according to the deviations noted/corrected
could be linked to chapter 3.1

All Audit Findings have been transferred to corrective action requests

Signature Name

Audit Closed QM Signature

Date