Continual Improvement Rev.

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Procedure
REVISION HISTORY

Rev Affected Prepared Approved

No. Page by by
Effective Date Change Descriptions

0 1 Oct 2020 All New issue

1. PURPOSE

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1.1 Continually improve the effectiveness of the Quality Management System through
the implementation of corrective action to resolve problems, elimination of root cause
of a non-conformance and prevent future recurrence, and preventive action to
prevent potential non-conformance from occurrence.

2. SCOPE

2.1 This shall cover the following area: -

i.) Customers’ / interested parties complaints/feedback
ii.) Process/ Product Quality Problems
iii.) Audit Findings
iv.) Supplier Problems
v.) Company Policy and Objectives.

3. REFERENCES

3.1 ISO 9001 Clause 10.1 (Continual Improvement)

3.2 ISO 9001 Clause 10.2 (Corrective Action)
3.3 Quality Manual)

Corrective Action flow

Detect non conforming
(internal audit / customer complaint / 2
supplier rejects/ internal rejects)
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Issue NCR (if necessary) ）

Investigate Root Cause

Determine the Corrective Action

Verify the action effectiveness

Discuss during Management Review

Corrective Action

Handling of customer written complaints

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i.) All customer complaint shall be directed to Director/Sales personnel/QC personnel
for reviewing whether the problems are caused by FSM or customer.
ii.) If the problem is cause by customer, Director/Sales personnel shall resolve the
problem with the customer for improvement and approval.
iii.) If the problem is cause by FSM’s process, the Production/QC department shall
investigate the root cause and whoever related to the problems shall be required to
solve the problems using NCR or the countermeasure format provided by customer.
iv.) The department concern shall analyze the process operation, quality record and
take appropriate corrective action to prevent from future occurrence.
v.) The NCR shall be verified by Director/Sales personnel once the corrective action is
implemented.
vi.) All received customer written complaint shall recorded into the customer complaint
form / NCR (if necessary).

Process Quality Problem

i.) When non-conforming found by QC personnel conduct the In-Process Checking/QC

inspection at WIP area or during delivery inspection, the non conformity shall be
segregate to ON HOLD area.
ii.) Respective person shall analyze the rootcause and issue NCR to respective
department (if necessary).
iii.) Respective department will fill up the root cause and countermeasure column and
return back to respective person within the specified time frame.
iv.) Once replied the NCR, respective person shall evaluate on root cause and
countermeasure reply by production.

Vendor’s Quality Problem

i.) For vendor/sub-contractor rejection, memo/ letter / NCR shall be issued for
corrective action.
ii.) Verification shall be done on the replied memo/ letter/ NCR based on the next
incoming lot or at supplier’s premises.

QMS Internal Audit

i.) Non-Comformance Report (NCR) shall be issued to the auditee/department who

does not comply to FSM QMS requirements.
ii.) The NCR must reply to QMR within 14 working days.

Preventive Action

i.) All sources of information regarding of QMS performance will be studied to

detect, analyze and eliminate potential cause of non-conformities as follow: -
Source of information Method Person Responsible

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1. Customer Complaints NCR Director/QC / Sales
personnel

2. Internal/External Audit NCR QMR,

Auditor concerned.

3. Supplier Quality Problem Memo/ Letter/ NCR QC

4. Process Quality Problem Inspection checklist / NCR QC

5. Outgoing/ Finished Good Goods Issued for Delivery Production

Record

ii.) The person responsible will initiate preventive action necessary to prevent quality
problem when the source of information indicate that a problem has or might occur.
iii.) Where the person responsible can do the preventive action, he must take necessary
step to ensure that it is done effectively and verify that action is effective.
iv.) Where the person responsible cannot do preventive action, he wills liaise with the
person who can do preventive action by raising appropriate forms.
v.) Where preventive action means a change in the documented procedure, the person
responsible will ensure that all change is implemented.
vi.) Review flow chart, present system and method, and evaluate the effectiveness, and
assign responsibilities.
vii.) Determine the root cause, set a team as necessary and evaluate an alternative
process and assign responsibilities.
viii.) Follow up on action to be taken to verify effectiveness of the preventive action.
ix.) The action items to be carried out will be documented with responsibilities assign
and target dates set.
x.) The result of corrective and preventive action shall be review during the
management review meeting to ensure it is effectively implemented and
maintained.

4.5 Improvement Needs

i.) Pareto diagram/Statistical Chart shall be used to determine the improvement needs.
ii.) Teams shall be assigned to solve the problems and dead line shall be set to review
the effectiveness on next Management Review.