Tailin Abrasives Corporation

Failure Mode & Effects Analysis (FMEA)

Doc. Code:

SOP-QC-16

Rev. No.:

3.3

Eff. Date:

02-Jul-2012

Page No

1 of 7

I OBJECTIVE: This course support Tailin Abrasive Corporation quality system, a systematic tool of identifying causes of failure on its abrasive products or entire processes. It will teach how to use statistical analysis to determine the probability of root cause occurring and the method of developing counter measure to advert the failure mode into question. Providing organizational development on identifying, analyzing and improving existing

processes

within Tailin Abrasive Corporation to meet new goals and objectives. As a specific methodology or strategy to create successful results. II SCOPE: Apply within the entire Tailin Abrasive Corporation processes as a concrete form of guidelines stands shock absorber / building blocks on every processes from operation, to development, and to disposal. III DEFINITION: Function

-

intended purpose of product or process

Failure Mode

-

physical description of failure, not identifying the intended purpose

Failure Effects

-

impact of failure on people, equipment, customer or downstream processes.

Failure cause

-

means by which a particular element of design or process results in a failure mode.

Detection

-

the identification and remediation of a failure cause or its consequent failure mode prior to deliver to the customer(any follow on user).

Occurrence

-

the perceived likelihood of a failure cause happening during the intended life and use of a product.

Severity

-

the impact an effect will have on the customer (any follow on user)

Risk Priority Number (RPN)

-

the mathematical product of the numerical Severity, Occurrence and Detection.

Reviewed by

C. Canonizado

Revised by

DCC

Approved by

Date

02-Jul-2012

Date

02-Jul-2012

Date

E. Jose

Tailin Abrasives Corporation

Failure Mode & Effects Analysis (FMEA)

Doc. Code:

SOP-QC-16

Rev. No.:

3.3

Eff. Date:

02-Jul-2012

Page No

2 of 7

IV DUTIES AND RESPONSIBILITIES: Process Expert

-

helps FMEA team to have a better perspective in pursuing prescribe controls and guidelines for continual improvement.

Team Adviser

-

oversees all team activities, ensuring its effectiveness and availability of resources.

Team Leader

-

monitor team duties and responsibilities, update project steps, lead in analyzing all gathered data.

Team Member

-

responsible on collecting and presenting of all reliable / useful data, provide a magnitude of input during problem solving and in-charge of verification on implemented mitigating action.

VI BACKGROUND INFORMATION: Failure Mode and Effects Analysis - (FMEA) is a logical, proactive technique that is used to identify and eliminate potential causes of failures. The technique was first used in the aerospace industry to find problems with an aircraft before it ever left the ground. Today, FMEA is in widespread use by a multitude of industries, many of which have begun imposing FMEA standards. With FMEA, potential failure modes in the process are identified in anticipation of the service encounter. In this way, the potential for errors is reduced or eliminated, allowing for only the smallest probability of customer dissatisfaction. FMEA and Six Sigma Framework - FMEA is one of the tools available in Six Sigma DMAIC under analyze, toolbox use for continuous process improvement “KAIZEN umbrella”. FMEA and ISO 16949 -Required component under element 4.2, Quality System and element 4.9, Process Control. Plays a key role in complying with element 4.14, Corrective and Preventive Action. 4.2.3 – Quality Planning, Process Failure Mode and Effects Analysis whose effort shall be taken to improved the process to achieve defect prevention rather than defect detection. VII STEPS IN COMPLETING FMEA: 1

Scope Project 1.1

Fill up FMEA start up work sheet as follows; control number, date started, team duties and responsibilities, target completion, boundaries, constrains ect.

1.2

All team member walk through process (process trailing using SOP), make notes / observations and interviews.

1.3

Record team members comments, expand, summarize or edit ideas.

Reviewed by

C. Canonizado

Revised by

DCC

Approved by

Date

02-Jul-2012

Date

02-Jul-2012

Date

E. Jose

Tailin Abrasives Corporation

Failure Mode & Effects Analysis (FMEA) 2

Doc. Code:

SOP-QC-16

Rev. No.:

3.3

Eff. Date:

02-Jul-2012

Page No

3 of 7

Brainstorm all Potential Failure Modes 2.1

Dissect process flow chart / SOP into each step.

2.2

Review all quality information such as complains, scrap, rework, reject, turn back/turn over etc.

2.3

Use individual knowledge, skills and experience to come out all potential failure modes from each step of previous and existing parts/process.

3

Identify Potential Effects of Failures 3.1

Operates on each failure mode, identify the effect(s)/consequence(s) on the current or next or customer down stream in the manufacturing and assembly line.

3.2 4

Describe the effects of failure in terms of what current or as a whole system might notice.

Determine Severity Ranking

4.1

Assign a numerical raking from 1 – 10 on how seriousness or impact on the current or next process (base on predetermined criteria)

EFFECT

Criteria: SEVERITY OF EFFECT DEFINE

RANKING

May endanger operator. Failure mode affects safe Hazardous: Without vehicle operation and / or involves noncompliance Warning with government regulation. Failure will occur WITHOUT warning.

10

Hazardous: With Warning

May endanger operator. Failure mode affects safe vehicle operation and / or involves noncompliance with government regulation. Failure will occur WITH warning.

9

Very High

Major disruption to production line. 100% of product may have to be scrapped. Vehicle / item inoperable, loss of primary function. Customer very dissatisfied.

8

High

Minor disruption to production line. Product may have to be sorted and a portion (less than 100%) scrapped. Vehicle operable, but at a reduced level of performance. Customer dissatisfied.

7

Moderate

Minor disruption to production line. A portion (less than 100%) may have to be scrapped (no sorting). Vehicle / item operable, but some comfort / convenience item(s) inoperable. Customers experience discomfort.

6

Low

Minor disruption to production line. The product may have to be sorted and a portion (less than 100%) reworked. Fit / finish / squeak / rattle item does not conform. Defect noticed by most customers.

5

Reviewed by

C. Canonizado

Revised by

DCC

Approved by

Date

02-Jul-2012

Date

02-Jul-2012

Date

E. Jose

Tailin Abrasives Corporation

Failure Mode & Effects Analysis (FMEA)

Rev. No.:

3.3

Eff. Date:

02-Jul-2012

Page No

4 of 7

Very low

Minor disruption to production line. A portion (less than 100%) of the product may have to be reworked on-line but out-of-station. Fit / finish / squeak / rattle item does not conform. Defect noticed by average customers.

4

Minor

Minor disruption to production line. A portion (less than 100%) of the product may have to be reworked on-line but out-of-station. Fit / finish / squeak / rattle item does not conform. Defect noticed by average customers.

3

Very Minor

Minor disruption to production line. A portion (less than 100%) of the product may have to be reworked on-line but in-station. Fit / finish / squeak / rattle item does not conform. Defect noticed by discriminating customers.

2

No effect.

1

None

5

SOP-QC-16

Doc. Code:

Identify all Potential Cause of Failure 5.1

Describe how failure occur in terms of something that can be correct or controlled.

5.2

Use technical problem solving, analytical thinking or experiments to determine failure causes. Noted there could be more than on cause fro each failure mode.

6

Determine Occurrence Ranking 6.1

Assign a numerical ranking from 1 – 10 to the perceived likelihood of a failure cause

happening during the intended life and use of a product.

OCCURRENCE RANKING

Probability of Failure

Possible Failure Rates

Very High:

Cpk < 0.33

≥ 1 in 2

Failure is almost inevitable

1 in 3

High: Generally associated with processes similar to previous

1 in 8

Processes that have often failed

1 in 20

Ranking 10

≥ 0.33

9

≥ 0.51

8

≥ 0.67

7

Reviewed by

C. Canonizado

Revised by

DCC

Approved by

Date

02-Jul-2012

Date

02-Jul-2012

Date

E. Jose

Tailin Abrasives Corporation

Failure Mode & Effects Analysis (FMEA) Moderate: Generally associated with processes

1 in 80

Previous processes which have

1 in 400

May experienced failures, but not proportions Low: associated processes

7

occasional in major

1 in 2,000

failures similar

1 in 15,000

Isolated with

SOP-QC-16

Doc. Code: Rev. No.:

3.3

Eff. Date:

02-Jul-2012

Page No

5 of 7

≥ 0.83

6

≥ 1.00

5

≥ 1.17

4

≥ 1.33

Very Low: Only isolated failures associated with almost identical processes

1 in 150,000

Remote: Failure is unlikely. No failures ever associated with almost identical processes

≤ 1 in 1,500,000

3

≥ 1.50

2

≥ 1.67

1

Define Current Control Methods 7.1

Using quality controls consist of mistake proofing, automated control, set up verifications, inspection, training, checklist, monitoring, job aids, ect determine current control(s).

8

Determine Detection Ranking 8.1

Assignment of numerical ranking from 1 – 10 to the perceived likelihood that the current controls (design and/or process) will detect a failure's cause or failure mode prior to the product reaching the customer or any follow on user based on the predetermine criteria. DETECTION RANKING

Detection

Criteria: Likelihood the existence of a defect will be detected by test content before product advances to next or subsequent process

Ranking

Almost Impossible

Test content detects < 80 % of failures

10

Very Remote

Test content must detect 80 % of failures

9

Remote

Test content must detect 82.5 % of failures

8

Reviewed by

C. Canonizado

Revised by

DCC

Approved by

Date

02-Jul-2012

Date

02-Jul-2012

Date

E. Jose

Tailin Abrasives Corporation

Failure Mode & Effects Analysis (FMEA)

9

SOP-QC-16

Doc. Code: Rev. No.:

3.3

Eff. Date:

02-Jul-2012

Page No

6 of 7

Very Low

Test content must detect 85 % of failures

7

Low

Test content must detect 87.5 % of failures

6

Moderate

Test content must detect 90 % of failures

5

Moderately High

Test content must detect 92.5 % of failures

4

High

Test content must detect 95 % of failures

3

Very High

Test content must detect 97.5 % of failures

2

Almost Certain

Test content must detect 99.5 % of failures

1

Calculate the Risk Priority Number (RPN) 9.1

Calculate the RPN's (equation: RPN = Severity Ranking x Occurrence Ranking x Detection Ranking) the arithmetic product.

9.2

Use the RPN's to select high priority failure modes and based on the highest prioritize actions so action. Note: any failure with severity rating of 10 must be worked on immediately because of impact on customers, even if it does not score a high RPN overall.

10

Prioritize Corrective Actions 10.1 Develop corrective action / recommended action, identify responsibilities and target date to complete action and record this action on the work sheet. Complying: Preventive action: steps that reduce the likelihood of problem occurring at all, focused on reducing/eliminating cause prior to occurrence. Contingent action: measures implemented to limit the damage caused by a potential problem should occur; focused on achieving the goal in spite of difficulties.

11

Reassess Ranking when Action Completed 11.1 Reassess raking whenever changes made to product/or process, recalculate and record the new ranking for Severity, Occurrence, Detection and RPN. Cycle back to Step 9 until marginal set in.

Reviewed by

C. Canonizado

Revised by

DCC

Approved by

Date

02-Jul-2012

Date

02-Jul-2012

Date

E. Jose

Tailin Abrasives Corporation

Failure Mode & Effects Analysis (FMEA)

Doc. Code:

SOP-QC-16

Rev. No.:

3.3

Eff. Date:

02-Jul-2012

Page No

7 of 7

FMEA TEAM START – UP WORKSHEET FMEA Number:

Date Started:

Team Members:

Date Completed:

Team Leader:

1. Are all affected areas represented? Yes

No

Action:

____________________________________________________ 2. Are different levels and type of knowledge presented on the team? Yes

No

Action:

____________________________________________________ 3. In the Customer involved? Yes

No

Action:

____________________________________________________ 4. Who will take minutes and maintain records? FMEA Team Boundaries of Freedom 5. What aspect of the FMEA is the team responsible for? 6. What is the Budget for FMEA? 7. Does the project have a deadline? 8. Do team have specific time constrains? 9. What is the procedure if the team needs to expand these boundaries 10. How should the FMEA be communicated to others 11. What is scope of the FMEA? (be specific and include a clear definition of the process on product to be studied.

Reviewed by

C. Canonizado

Revised by

DCC

Approved by

Date

02-Jul-2012

Date

02-Jul-2012

Date

E. Jose