Oberoende granskning –

vad är det?

Del-21G seminarium 2015 Jukka Salo Slou

Oberoende – vad är det?

Självständig, fri, obunden,

oavhängig, neutral, suverän,

autonom!

2

Xxx AB

2015-10-30

Privilegiet Regeln

Produktion

Tillståndet

Oberoende granskning

CMM

SM

AM

Produkten

Circle of Life!

KUND

NPH

Låt oss se på regelverket… 21G

21.A.139 Quality System

• (b) The quality system shall contain:

• 2. An independent quality assurance function to monitor

compliance with, and adequacy of, the documented procedures

of the quality system.

• This monitoring shall include a feedback system to the person or

group of persons referred to in point 21.A.145(c)(2) and ultimately

to the manager referred to in point 21.A.145(c)(1) to ensure, as

necessary, corrective action.

2015-10-30

4

Låt oss se på regelverket…21G

GM No. 1 to 21.A.139(b)(2) Quality System –

Independent quality assurance function

• The quality assurance function which is part of the

organisation is required to be independent from the

functions being monitored. This required

independence relates to the lines of reporting,

authority and access within the organisation and

assumes an ability to work without technical

reliance on the monitored functions.

2015-10-30

5

Låt oss se på regelverket…21G

GM No. 2 to 21.A.139(b)(2) Quality System – Adequacy of

procedures and monitoring function

• Adequacy of procedures means that the quality system, through

the use of the procedures as set forth, is capable of meeting the

conformity objectives identified in 21.A.139(a).

• The quality assurance function to ensure the above should

perform planned continuing and systematic evaluations or

audits of factors that affect the conformity (and, where required,

safe operation) of the products, parts or appliances to the

applicable design.

• This evaluation should include all elements of the quality

system in order to demonstrate compliance with Part 21 Subpart

G.

2015-10-30

6

Låt oss se på regelverket…21G

• 21.A.139 Quality System

(b) The quality system shall contain:

• 1. as applicable within the scope of approval, control

procedures for:

• ……..

• (xiv) internal quality audits and resulting corrective

actions;

2015-10-30

7

Låt oss se på regelverket…147

147.A.130(b)

The organisation shall establish a quality system

including:

• 1. an independent audit function to monitor training

standards, the integrity of knowledge examinations

and practical assessments, compliance with and

adequacy of the procedures, and

• 2. a feedback system of audit findings to the person(s)

and ultimately to the accountable manager referred

to in point 147.A.105(a) to ensure, as necessary,

corrective action.

2015-10-30

8

Låt oss se på regelverket…147

AMC 147.A.130(b)

• The independent audit procedure should ensure that all aspects

of Part-147 compliance should be checked at least once in every

12 months and may be carried out as one complete single

exercise or subdivided over a 12- month period in accordance

with a scheduled plan.

• 5. The independence of the audit system should be established

by always ensuring that audits are carried out by personnel not

responsible for the function or procedure being checked.

2015-10-30

9

Låt oss se på regelverket…147

AMC 147.A.130(b)

The independent audit is a process of routine sample

checks of all aspect of the training organisation’s

ability to carry out all training and examinations to

the required standards.

• The management control and follow-up system should

not be contracted to outside persons. The principal

function is to ensure that all findings resulting from the

independent audit are corrected in a timely manner

and to enable the accountable manager to remain

properly informed of the state of compliance. Apart

from rectification of findings,

2015-10-30

10

Låt oss se på regelverket…147

AMC 147.A.130(b)

• the accountable manager should hold

routine meetings to check progress on

rectification

except that in the large training organisation such

meetings may be delegated on a day-to-day basis

to the quality manager

as long as the accountable manager meets

at least once per year with the senior staff

involved to review the overall performance.

2015-10-30

11

Låt oss se på regelverket…147

PART 3 – TRAINING SYSTEM QUALITY

PROCEDURES

• 3.1. Audit of training

• 3.2. Audit of examinations

• 3.3. Analysis of examination results

• 3.4. Audit and analysis remedial action

• 3.5. Accountable manager annual review

• 3.6. Qualifying the instructors

• 3.7. Qualifying the examiners and the assessors

• 3.8. Records of qualified instructors & examiners

2015-10-30

12

Låt oss se på regelverket…145

AMC 145.A.65(c)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 2015-10-30

13

Låt oss se på regelverket…145

AMC 145.A.65(c)2

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.

2015-10-30

14

Summasumarum…

Del-21G;

• ”Quality system” inkluderar procedurer för oberoende granskning

(internaudit)

• ”Quality system” skall auditeras (som en ingående procedur i

21.A.139.

Del-147;

• ”Quality system” inkluderar procedur för oberoende granskning

• Quality system skall auditera ”Verksamheten”

• AM skall auditera Quality system

Del-145;

• ”Quality system” inkluderar procedur för oberoende granskning

• Quality system skall auditera ”Verksamheten”

• AM skall auditera Quality system

2015-10-30

15

Summasumarum… 21G

Quality system skall auditeras systematiskt och

planerat av en oberoende funktion;

• Extern auditör

• Oberoende intern auditör

Eller

• AM

(förutsätter skrivna procedurer för

tillvägagångssätt och dokumentation i POE)

2015-10-30

16

AM… 21.A.145 Approval requirements

(c) with regard to management and staff:

• 1. a manager has been nominated by the production

organisation, and is accountable to the competent

authority. His or her responsibility within the

organisation shall consist of ensuring that all

production is performed to the required standards

and that the production organisation is continuously

in compliance with the data and procedures identified

in the exposition referred to in point 21.A.143;

• Närvaro

• Kunskap om produkten

• Kunskap om regelverket

2015-10-30

17

GM 21.A.145(c)(1) Approval

Requirements – Accountable manager

• Accountable manager means the manager who is responsible,

and has corporate authority for ensuring that all production work is

carried out to the required standard.

• The manager is responsible for ensuring that all necessary

resources are available and properly used in order to produce

under the production approval in accordance with Part 21

Section A Subpart G.

• The manager needs to have sufficient knowledge and authority

to enable him or her to respond to the competent authority

regarding major issues of the production approval and implement

necessary improvements.

• The manager needs to be able to demonstrate that he or she is

fully aware of and supports the quality policy and maintains

adequate links with the quality manager.

2015-10-30

18

AM - SM - Safety Manager/CCM –

Compliance Monitoring Manager Focus on; Management system – including;

• Monitoring of Compliance,

independent auditing

• Reporting to management

• Effective corrective actions

• Follow up

• Hazard identification

• Risk assessment

• Mitigation

• Effective actions

• Safety reporting scheme

2015-10-30

19

CMM

(QM)

SM

AM

FOKUS!

AM…

• Närvaro

• Kunskap om produkten

• Kunskap om regelverket

2015-10-30

20

Tack för er

uppmärksamhet!

2015-10-30

21