R SP MFG AS STD Aware+action List 15Feb23-Batam

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Company: PT-SP Manufacturing Dear All,

Re-Schedule the AS9100 training into Wed/ 15 Feb 2023. Thank you.
Date 15 Feb 2023 Hello Team,
Subject: AS 9100 std awareness I would like invite the team to attend the AS9100 Aerospace standard training
by our GT Consultant which plan be held on below schedule.
Please refer to attached training module as our reference.
Date : Wed/ 18-January-2023
Time : 9.30am – 17.00
Venue : PTM Conference Room
For SPM Team, can joint by using below Webex link :
https://spmanufacturingpteltd.my.webex.com/meet/spwebexmeeting20
TAUFIQ SHELIAGUNG
PTE – QA Manager
S/N Topics Remarks
1) 9.45am to 10.40am- Pre- course quiz +class training;
10.40am to 10.55am- morning break;
10.55am to 11.55am- class training;
11.55am to 1.00pm- lunch;
1.00pm to 1.50pm- class training;
1.50pm to 2.00pm- washroom break;
2.00pm to 2.50pm- class training;
3.00pm to 3.15pm- afternoon break;
3.10pm to 4.30pm- class training, quiz of time permits.
2)

3) What are the ISO certification that current PT SP manufacturing has;


1. ISO 14001- environmental management system;
2. ISO 13485- medical device Quality management system;
3. ISO 9001- Quality management system- general;
4. IATF 16949- automotive quality management system;
5. ESD 20.20- ESD std for conducting of the electrical discharge;
6. New std- AS 9100 Rev D- Aerospace quality management system;

4) IATF 16949- automotive quality management system;


Core Tools;
a. APQP/Control plan- advance product quality planning- prepare for production, project management-How
many phases are in the APQP- 5 phases 1)planning, 2) Design 3)process design 4)validation, 5) production;-
edition 2nd edition.
b. MSA- measurement system analysis- error in the system, GR&R, ANOVA, KAPPA, bias, linearity;
c. FMEA- Process FMEA, which edition you are using- AIAG 4th edition;
d. SPC- statistical process control- study the CPK, PPK,;- 1.33;
e. PPAP- Product Part Approval Process- First Article submission- 18 items to submit, Level 3.- 4 th edition.
f. error- proof- jig and ficture- using the orientation approach, test report.

5) New std- AS 9100 Rev D- Aerospace quality management system;


a. AS 9145:2016-Aerospace Series –Requirements for Advanced Product Quality

AS 9100- class notes Page 1 of 11


Planning (APQP)- 5 phases and Production Part Approval Process (PPAP)- 11 items
b. AS9102:2014 First Article Requirements- First article submission- 3 forms to be
submitted.

6) ISO 9001- Quality management system- general;


a. How many auditable clauses;-
1. Clause 4-context of the organisation;
2. Clause 5- Leadership;
3. Clause 6- Planning;
4. Clause 7- Support;
5. Clause 8- Operations;
6. Clause 9- Performance evaluation;
7. Clause 10- Improvement.- CAR

7) ISO 13485- medical device Quality management system;


Supporting std;
1. Validation std- ISO 14969;- validation Plan. A) IQ- installation qualification, b)OQ-
Operational qualification , c)PQ- Performance qualification, d) re-validation-maintenance,
calibration.
2. Risk mgt std- ISO 14971:2019;- a) Risk plan, b) risk assessment- FMEA, c) Risk review- report,
d) post production survillance.

AS 9100- class notes Page 2 of 11


8)
The whole of the AS certification needs
Tier Details
1 Customer requirements;
1. Product specific requirement;- safety, special, KC, CI
2. Process specific requirement; CPK, parameter requirement;
3. System specific requirement CAR response time;
- 8D- 8 Disciplines;
D0- symptom;
D1- Team- Production, QA, SC, Sales;
D2- problem statement- 5W,1H- what, where, when, who, why- H-
how- many, often, much;
D3- Containment, correction;
D4- Root Cause Analysis- 5WHY, WHY-WHY, fish bone;
D5- verify the corrective action;
D6- verify the effectiveness of the corrective action;
D7- Preventive action and improvement;
D8- Congratulation!!! Lesson Learned.

2 AS 9145 std- specific std- cannot be certified alone.


- APQP (advanced product quality Planning- 5 phases, 1st- phase- planning,
2nd phase product Design and development, 3rd Phase- process design and
development, 4th product and process validation ( PPAP), 5th- feedback
and improvement) and

- PPAP requirement;- Production Part Approval Process- 11 items to be


submitted.

3 AS 9102 std- specific std- cannot be certified alone


First article requirement, 3 forms to be fille up.
Form 1; part number accountability;
Form 2- Product accountability;
Form 3- Characteristic accountability

4 AS 9100:2016 rev D- specific requirement


- Counterfeit;
- Product safety;
5 ISO 9001:2015 QMS std as the basis;
The auditable clauses; 7 clauses;
Starts from 4,5,6,7,8,9 and 10.

9) product configuration-
a. Design;
b. Layout;
c. Revision.
10) AS std does not have a “preventive action”..Where did the “Preventive Action” goes to?
1. Risk management- FMEA; risk plan;
2. Clause 6.1- Risk and opportunity assessment.

11) What is ethical behavior?- act of employee to perform the duty according to the behavior defined in
the handbook, a) cannot take money from customer directly or under table, b)cannot give
confidential information to 3rd parties.
How to control?- signing the declaration of the ethical behavior. And signing of the attendance.

12) What is considered as mandatory;


1. May;
AS 9100- class notes Page 3 of 11
2. Should;
3. Shall; mandatory
4. Must; mandatory
5. Note:
13) Counterfeit check;
a. Authorised dealer. Distributor;
b. COC;
c. Incoming inspection- label, outlook;
d. Price;
e. Peform a comparison check by the decapping on the die marking. (only for IC)
14)

Context diagram;
Internal parties. External parties, business process flow, sequence and interaction.
15) Intergated phases processes.

16)

In APQP file

17) Initial process capability study;


CPK=

AS 9100- class notes Page 4 of 11


18)

19) MSA

20) Maintenance objectives;


1. OEE=availability Xperformance X quality= 80%/100%
2. MTBF= mean time between failure=??
3. MTTR= mean time to repair.=??

21) 2 types of risk;


1. 6.1- QMS process risk; PESTLE; SWOT
P- political, E- economic-recession, S- social-pandemic, T- technology-industries 4.0, L= Legal,
E-environmental= ROA (risk and opportunity assessment)
2. 8.1- operational process risk- PFMEA

AS 9100- class notes Page 5 of 11


22) 1.55pm to 2.05pm- wash the room break
23) Additional process control= treatment= in the control plan = reaction column;- cosmetic issue.

Rework, repair affects = form fit function, performance/ durability= addition FMEA, approval,
instruction, reinspection.
24)

25) What is organisation knowledge?

AS 9100- class notes Page 6 of 11


26) Configuration management;
1. Identification;
2. Traceability;
3. Change control.

27) Sampling plan;

AS 9100- class notes Page 7 of 11


AQL
C=0
ISO 2859 std= MIL-STD- 105E= ASQC Z 1.4 std.

28) 4.03pm to 4.10pm to do the quiz from 11 to 20;

AS 9100- class notes Page 8 of 11


AS std Action items
1) To verify with the certification body on the simulated product for AS std certification. Mr Chiang

2) To ask from the customer on the special characteristic requirement, safety, critical, Mr Chiang
special, KC, CI.
3) To ask for any further Customer Specific PPAP Requirements for AS product. Mr Chiang

4) Clause 7.3; Jenny/ Beatrice To formulate the


to help to awareness
The awareness items to the staff and new hired staff. formulate the information
items to conduct
the awareness

5) First article Form 1, 2 and 3 to assigned Mr Chiang


- First article forms to be filled up. to assign
staff.-
attach
-
To identify a model that
6) Program to formulate the APQP file Mr Mike/ can used for simulation
and have mess production
Ms. Yunita data

7) Process design and development; Mr Eric/ To gather data


1. Process design planning and timing schedule; for the part that
William/ going for
2. Process input- parameter; Mr Suep simulation
3. Process output- line layout;- various station;
4. Process review- internal review;
5. Process verification- test the individual station;
6. Process validation- first article run;
7. Process change control- ECN change.
8) MSA study- equipment listed in the control plan Mr Eric/ Identify the
GR&R; model and gather
William/ the GR&R
Linearity; Mr Suep; information
Stability; QA- Mr
Bias.
Taufiq/

9) SPC study- Mr Eric/ Identify the


Chart use- X-bar- R chart model line and
William/ provide the X bar
Mr Suep; R Chart- n is from
QA- Mr 2 to 10
Taufiq/

10) Process FMEA and control plan Mr Eric/ To provide the


FMEA and control
William/ plan for the
Mr Suep; model to be
audited.
11) Packaging, Preservation, and Labelling Approvals Mr Eric/ To identify the
model and provide

AS 9100- class notes Page 9 of 11


William/ the evidence.

Mr Suep;
12) BCMS information and report- contingency plan PTE- To provide the
BCMS for the PT SP
QA- Mr mfg, the
Taufiq/ contingency plan
and exercise
Jenny information
Mr Suep;
13) Human factor consideration of the nonconformity and corrective action; Mr Eric/ Error proof
What is the human factors that they are referring to? William/ report-
a. Not following to procedure- errors to the product; Mr Suep;
b. Error proof testing?

14) Legal register. Jenny to To formulate


ROHS; identify the the legal
REACH; legal register.
Logistics, IATA requirement register
15) Foreign object to be removed and the evidence to be shown. Mr Eric/ To show the WI and
the evidences of
William/ the removal of
Mr Suep; foreign – inspection
report
16) capability study (CPK). QA- Mr To provide
Taufiq/ the CPK
information
17) Capacity (quantity). Tanto. To provide the cycle
time and the
capacity study
information
18) FMECA- criticality = end user risk. Mr Eric/ To extend to
Usability to be added into the current FMEA. (if applicable). William/ the end user
Mr Suep; or the
customer
factory risk
19) No specific outsource work, no transfer needed. For
informatio
n
20) Simulation of the recall process. PTE- Report to
QA- Mr show the
Taufiq/ capability of
Jenny recall.
21) ISO 13485- validation- ISO 14969:2004 validation requirement; Kent IQ For
IQ-installation qualification- electrical, water, pressure, temperature. (equipment) format consideratio
OQ- operation qualification- parameter; n
PQ- Performance qualification- SPC, stability.

22) Validation report- reflow temp. profile. Mr Eric/ Suep to


William/ show the

AS 9100- class notes Page 10 of 11


Mr Suep; validation
report
23) Control plan linked to the APQP std- 2nd edition. For
informatio
n

24) Product life= to be the life provided to the customer on the product for the duration David to
that the product was shipped out to the customer from the plant. confirm on
the
product life
with the
customer
contract.
25) Repair/ rework requirements to be confirmed. David to
confirm on
the repair
and rework

26) Sourcing on the external provider. Wan Cheng- on


the agreement
to have the
supplier in the
chain of
investigation if
needed.
27) PT. SP Manufacturing ( PTE Main Site)
Address :
JI. Raja Isa, Kawasan Industri Tunas Biz park, Type 12 - A,
Kelurahan Belian, Kecamatan Batam Kota, ID - 29464 Kodya Batam
Scope of Certificate : Manufacturing of Printed Circuit board Assemblies
Headcount : ~ 211
Workdays : 5.5 day week
Shift: Able to go up to 3 shifts
PT. SP Manufacturing ( PTM Remote Site 1)
HR support
IT support
Doc Control
SP Manufacturing ( Sg Remote Site 2)
Business Development
Program
Sourcing
Purchasing
IT
Engrg & QA support

AS 9100- class notes Page 11 of 11

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