Wednesday, May 29, 2024

IATF16949(ISO9001) {6.2} Quality Objectives and Planning to achieve them

IATF16949(ISO9001) {6.2} Quality Objectives and Planning to achieve them

See ISO 9001:2015 requirements.
6.2.1
The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.
The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements"
d) be relevant to conformity of products and services and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate

The organization shall maintain documented information on the quality objectives.

6.2.2
When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
 e) how the results will be evaluated

6.2.2.1 Quality objectives and planning to achieve them — supplemental

Top management shall ensure that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization.
The results of the organization’s review regarding interested parties and their relevant requirements shall be
considered when the organization establishes its annual (at a minimum) quality objectives and related performance
targets (internal and external). 

Explanation - Quality Objectives/Key Performance Indicator can be defined and implemented as per below Procedure 

KPI / QUALITY OBJECTIVE MONITORING PROCEDURE 

Define Quality Objectives/ KPI for Process effectiveness and efficiency monitoring for all department.

Define monitoring frequency based on previous performance, current status, customer feedback, etc.

Collect the data for decided KPI & objectives from previous MIS & daily monitoring record, Assign responsibility & benchmarking for process performance in form of KPI & objective along with timeline.
  
Plan the activities how to achieve its quality objectives & KPI’s.
Determine the following & make action plan :
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.

Monitor the KPI & objectives as per decided frequency against set targets.

 Communicate the status of monitoring of quality objectives & KPI’s to top management on monthly basis.

Prepare the action plan on non achieved objective with root cause analysis.

Submit the decided action to Management Representative with action target date & responsibility for management review meeting discussions. 

Quality Objective Target will be revised to 2-5% more or less than previous target if all target are achieved in last six month.

If target is not achieved then Target will remain same. 

Top Management / Management Representative will decide the target during MRM Review depending on quality objective indicators.

MANAGEMENT REVIEW MEETING (MRM)

MANAGEMENT REVIEW MEETING (MRM)

Organize the Management review meeting once in six months or three months if IATF 16949:2016 Standard is recently implemented.
  
Send the intimation note including the agenda points of Management Review Meeting (MRM) to all DH, DIRECTOR, CMD, stating the date, time and venue at least 7 to 10 days in advance.

Conduct discussions with concerned departmental head and collect backup data and the details.

Conduct the Management Review meeting as scheduled. 

The Chair person for the meeting shall be the CMD and in his absence, the DIRECTOR will be chair person.

The minutes of the meeting are noted the salient points discussed and actions to be taken and identifying the responsibility and target date for each activity.

The backup information is stored in the Server records as Annexures to the minutes.

The minutes of the meeting in the on line file is shared with all concerned participants.

Monitor the proposed actions agreed by individuals, on the target dates for their progress/completion. 

Follow up the actions in the next MRM.

INTERNAL SYSTEM AUDIT

INTERNAL SYSTEM AUDIT

Prepare a list of trained internal auditors identifying Training details and department. 
 
Prepare an annual audit plan at the beginning of each financial year.

Conduct Internal Audit at frequency of once in Six months as planned in Annual Audit Plan. 

Plan the audit in such a way that all the shifts are audited at the scheduled frequency.

In case if Management Representative finds more NC than usual in internal / external audit, frequency of audit can be increased for the department based on Management Representative decision.

Update the annual audit plan.

Prepare a schedule for internal audit identifying the auditors, clauses, date, time and issue to all departments before min 10 days of audit through email / display board.

Fill the audit observation sheet Covering all the details observed (compliance and non-compliances) and all clauses audited. 

Ensure by reviewing the audit observation sheet whether auditors covered all Applicable clauses and Sign the audit observation sheet.

During audit, all NC points of  last audit shall also be verified.

Complete the Non-conformity reports identifying appropriate clause of IATF 16949:2016 standard and the objective evidence.

Send the NCR’s to the auditee and receive proposed disposition and corrective actions with target date from auditee within 7 days of audit.

Countermeasures shall be taken within 30 days of NC raising.

If more time is required for NC Closure, approval to be taken from Top Management.

Prepare a summary of the Internal Audit conducted identifying clause wise and department-wise breakup of NCR’s. 

Close the NCR’s based on satisfactory completion of actions proposed and verification of objective evidences on target date agreed by the auditee.

Discuss the closure of NCR’s in the Management Review Meetings.

Tuesday, May 28, 2024

IDENTIFICATION OF RISKS AND OPPORTUNITIES

IDENTIFICATION OF RISKS AND OPPORTUNITIES 

Identify external & internal issues which are relevant to purpose of strategic direction of the organization.

Consider internal & external issues to enhance desirable effects & give assurance to achieve the intended result of Quality Management System.

Determine the risk and opportunities need to be addressed to
To give assurance that the quality management system can achieve its intended results;

Enhance desirable effects

Prevent, or reduce, undesired effects

achieve improvement  

Prepare Risk Analysis Sheet to prevent undesired effect & to achieve continual improvement of the QMS. 

Review the Risk Analysis Sheet as per Process Risk Analysis Review Plan at six-month frequency.

After analysis of risk identify opportunities associated in respective process, identify the controls required to reduce the risk.

Take appropriate action to reduce risk and for identified opportunities. 

When planning these actions, shall consider its technological options and its financial, operational and business requirements

Discuss the action taken to reduce the risk and addressed opportunities and effectiveness of action taken in every MRM.

ENERGY MANAGEMENT

ENERGY MANAGEMENT 

The Internal energy audit Plan defines the Frequency of the internal energy audit. 

Internal energy audit check sheet includes general checkpoint that helps identify energy waste and identify opportunities for improving energy practices in various departments / areas.

Internal energy audit Report includes verification, monitoring and analysis of use of energy which including submission of technical report containing recommendations for improving energy efficiency with cost benefit analysis and an action plan to reduce energy consumption.

MACHINE BREAKDOWN MAINTENANCE AND ANALYSIS

MACHINE BREAKDOWN MAINTENANCE AND ANALYSIS 

In case of any equipment breakdown, make sure that the equipment user dept raises a machine breakdown memo to the concern maintenance team.

Supervisor/operators shall inform Maintenance In-charge about the Breakdown through Machine Breakdown Memo. 

Maintenance in-charge will allocate internal technician / external agency personnel depending on nature of breakdown based on information provided by supervisor / operator.

Maintenance technician will monitor the breakdown maintenance activities and record the same in Breakdown maintenance register. 

Corrective actions will be taken as appropriate by Maintenance In-charge with need based guidance of Top Management/other personnel and recorded in Corrective action Report 

Analysis is carried out on not meeting targets.

Maintenance technician reviews the effectiveness of breakdown maintenance by checking the working of machine and only after positive confirmation hands over the machine to respective department through endorsement in the breakdown maintenance register. 

Follow same process for Poka-Yoke Breakdown but record in separate register.

The root cause analysis is to be done monthly basis on top one major breakdowns, Repetitive Breakdown of same nature & cause and Poka-Yoke Failure. 

Corrective Action is to be taken on the basic of analysis.

The machine history card is accordingly updated.

 Machine down-time recorded in breakdown maintenance register is also entered in the system for enabling of calculation of Overall equipment effectiveness as well as machine utilization data.

Calculate the MTTR (Mean Time To Repair) & MTBR (Mean Time Between Failures) with considering all the events occurs. 

 Record the details in MTTR /MTBF Monitoring Sheet and analysis done on not meeting targets.

During break down repair if machine is not repairable by in-house or by external agency then machine scrap card is to be filled by Maintenance Head. 

After taking approval from Top Management ,machine is to be scrapped/disposed and list of scrap machine is to be updated.

PREDICTIVE MAINTENANCE OF MACHINE

PREDICTIVE MAINTENANCE OF MACHINE

The data contained in Preventive maintenance register, Breakdown maintenance register and statistical control charts are utilized to estimate life of parts /components which are prone to wear and tear.

Accordingly, detection /prediction of future potential failures are made.

The detail of predictive maintenance carried out is recorded in the Predictive Maintenance Register.

Any changes resulting in preventive maintenance schedule due to predictive maintenance activity results are accordingly incorporated in the preventive maintenance schedule.

PREVENTIVE MAINTENANCE OF MACHINE

PREVENTIVE MAINTENANCE OF MACHINE

Prepare a list of all machines under preventive maintenance including utilities which are used within organization.

The Preventive Maintenance Plan defines the Frequency of the Preventive Maintenance for that machine and it is dependent on the operating hours and breakdown history for that machine.

 For machines under AMC, Operating hours monitoring is been done and their maintenance is planned and carried out according to their operating hours by external agencies.


Preventive maintenance check sheet defines preventive maintenance checkpoints.

The same is documented / updated based on inputs of breakdown, preventive and predictive maintenance activity.  

Any unplanned preventive maintenance is also carried out based on breakdown maintenance.

While conducting preventive maintenance, if any part is found damaged or faulty, it is replaced / repaired as needed and the spares list is updated for the consumed parts.

Carry out daily preventive maintenance checklist before starting of production for machines and tools as per daily maintenance checklist and record the details in daily maintenance checklist.

If any part is replaced during preventive or breakdown maintenance same to be update in Machine History Card.

PACKAGING AND DISPATCH OF MATERIAL

PACKAGING AND DISPATCH OF MATERIAL

Receipt the dispatch plan from production department with material quantity, customer details and packing requirement. 

Plan the dispatch activities, resources for dispatch and execute the dispatch activities accordingly.

Prepare material requisition slip which is required from FG stores, other material collect from production.

Receipt the final inspected material from both departments with identification tag / PDI report collect from PDI section.

Review all document & material status PDI accepted material.

 Prepare the packing slip as per material availability and pack the material as per standard packing chart / standard operating procedure.
  
Identify the material with packing label with all material details on packet I.e. Customer Name, Item name, Part number, quantity, date etc.  

Prepare dispatch documents i.e. invoice, packing slip, PDI report.
 
Dispatch the material through approved tranporter & monitor dispatch plan completion performance on monthly basis.

Premium Fright :

Monitor the Premium Freight against Late delivery Incidences (Customer), Customer return, transport charges etc & record the details in Premium Freight Report.

BREAKDOWN MAINTENANCE OF TOOLS

BREAKDOWN MAINTENANCE OF TOOLS

Machine operator should inform to the tool room person regarding breakdown of tool through Tooling Memo.

After completion of breakdown maintenance of Tools, get the first piece inspected, if it is OK then handover the die for production.

While conducting preventive maintenance, if any part is found damaged or faulty, it is replaced / repaired as needed and update the Tool Spares Stock register for the consumed parts.

At the end of every month prepare tool breakdown hour’s summary report.

Carry out analysis on major contributing factors to reduce the tool breakdown hours.

Preserve all tooling in their respective storage locations / racks. 

Tool Life will be calculated and decided at the time of tool manufacturing by die maker. 

PREVENTIVE MAINTENANCE OF TOOLS

PREVENTIVE MAINTENANCE OF TOOLS

A List of tools is prepared and maintained.

 Tools are identified with unique numbers / locations for safe storage & easy retrieval. 

Prepare preventive maintenance check sheet for all press tools. 

Carryout tool verification as per decided frequency in Tool PM Module and monitor the tool life by monitoring quantity produced by that tool in each die loading and unloading time. 

The inspection of tooling involves the following:
         a) Verification of tool with respect to boundary dimensions, where applicable.
         b)  Visual Inspection of tool for surface finish 
         c) Tool is mounted and process is run at flow rates matching production situation to produce part/component.

Accordingly based on tool and part inspection using calibrated instrumentation, the tool is accepted/rejected and same endorsed on Tool history card.

Inventory of Non-consumable /non-perishable tooling is controlled through Tool History card.

 If tools are to be rejected / reworked then the same is identified accordingly and kept in designated area.

INTERESTED PARTIES AS PER IATF 16949:2016 AND ISO 9001:2015

INTERESTED PARTIES AS PER IATF 16949:2016 AND ISO 9001:2015

External Interested Parties : 
Customers 
External Providers 
Transporters 
Competitors 
Stakeholders 
Gujarat Pollution Control Board (GPCB) 
Directorate of Industrial Health and Safety (DISH)
Office of Labour Commissioner
Employees State Insurance Corporation(ESIC)

Internal Interested Parties : 
Employees 
Board of Directors 
Contractors & Contract Workers 
Security Contractor and Security Staff 

EXTERNAL AND INTERNAL ISSUES AS PER IATF 16949:2016 & ISO 9001:2015

EXTERNAL AND INTERNAL ISSUES AS PER IATF 16949:2016 & ISO 9001:2015

The following external issues are identified which are having positive and negative impacts on quality management system

Requirements of statutory bodies.

Requirements stated by IATF 16949:2016 and ISO 9001:2015 standards. 

Legal Requirements of Factory Inspector and Labour Commissioner. 

Customer requirements of product quality and quality management system.  

Following internal issues are identified which are having positive and negative impacts on quality management system.

Rejection Index 

Customer Delivery Requirements 

Storage Condition 

Maintaining  safety Requirements during manufacturing  

Employee Competence 

Extraneous material flow 

IATF16949 {8.5.1.1} Control Plan

IATF16949 {8.5.1.1} Control Plan
The organization shall develop control plans (in accordance with Annex A)at the system, subsystem, component, and/or material level for the relevant manufacturing site and all product supplied, including those for processes producing bulk materials as well as parts. Family control plans are acceptable for bulk material and similar parts using a common manufacturing process.

The organization shall have a control plan for pre-launch and production that shows linkage and incorporates information from the design risk analysis (if provided by the customer),process flow diagram, and manufacturing process risk analysis outputs( such as FMEA).

The organization shall, if required by the customer, provide measurement and conformity data collected during
execution of either the pre-launch or production control plans. The organization shall include in the control plan:
a) controls used for the manufacturing process control, including verification of job set-ups;
b) first-off/last-off part validation, as applicable;
c) methods for monitoring of control exercised over special characteristics (see Annex A)defined by both the customer and the organization;
d) the customer-required information, if any;
e) specified reaction plan (see Annex A); when nonconforming product is detected, the process becomes statistically unstable or not statistically capable.The organization shall review control plans, and update as required, for any of the following:
f) the organization determines it has shipped nonconforming product to the customer;
g) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA) (see Annex A);
h) after a customer complaint and implementation of the associated corrective action, when applicable;
i) at a set frequency based on a risk analysis.

If required by the customer, the organization shall obtain customer approval after review or revision of the
control plan

Explanation - Control Plan can be made by referring following Procedure 

PROCEDURE OF CONTROL PLAN
 

Collect the Control Plan Blank Format
Write the Component Part no/latest change level, customer Eng. Approval date, Component Part no., part revision status, CFT team detail, key contact, type of control plan, Control plan origin date, revision no., last and next review date.

As control plan is live document it should be review at define frequency (1 Year). Control plan will be revised in case of customer complaint received if required

Control plan can be also revised in the following cases.
-ECN/PCN
-Supplier change
-process change

Write down the Process Steps/Operation No as mentioned in the Process Flow Diagram (PFD) of respective product.

Write down the name of the Process Name/Operation Description with its no.as mention in the Process Flow Diagram (PFD) of respective product.

Identify &Mention the Machine/Device/Jig/tool used to complete the operation


Write down the Process and Product Characteristics separately. Process Characteristics can be obtained from PFD whereas Product characterizes can be taken from Product Drawing.
e.g.
Process Characteristic - Tempering Temp 360°± 10°
Product Characteristics -  Thickness 1.75 ± 0.05

Write the Classification of Product or Process in terms of "Critical" or "Special" Characteristics if any, with specific symbols assigned to them.

Identify & Mention the Product/Process specification/Tolerances

Identify & Mention the Evaluation/ Measurement techniques to measure the process & product characteristics

Identify & Mention the sample size of measurement

Identify and Mention the Control method

If it is [Safety/ Regulatory] Follow Any One of the Following Control method

1.Prevention Poke Yoke
2.Detection Poke Yoke
3. Online SPC (Control Chart)
4.100% Gauge Check (If Applicable)
5. 100% Inspection for Visual Defects

If it is Significant/Critical. (Affecting Primary Function) Follow Any one of the Control Method

1.Prevention/ Detection Poke Yoke
2. Online SPC (Control Chart)
3.Product & Process Inspection Reports & Gauge Report (If Applicable)
4.CMM Inspection Report
5. 100% Inspection for Visual Defects

For General Characteristic
1. Start Up Check Sheet
2.First off Inspection
3.Inprocess Inspection
4.Final Inspection Report
5.Gauge Report. (If Applicable) ,
6.100 % Inspection for Visual defects.

Identify and Mention Error Proofing/Poka Yoke system to prevent the potential defect like
[1. Operation Missing
2. Sub Part missing
3. Model mix - up
4. Fitment problem
5. Dimension variation
6. Possibility of wrong loading
7. Functional problem.

Also defined Testing Frequency of Error Proofing Device / Poka Yoke.

Initiate Reaction Plan to avoid producing Non Conforming Products. Also define reaction plan for Error Proofing Device / Poka Yoke.

Mention the Corrective Action Plan

Mention the revision history for changes of the Control Plan with date of revision and describe of the revision, when the document is revised for any reason. Take the signs of the CFT member present for the review.

Audit the document. If OK, sign the document for approval. File the " MASTER COPY' of Control Plan, Ensure Master List is updated for latest revision

Release the Control Plan and handover a Controlled Copy to
QA and Production

Review:
QA Head Reviews Control Plan based on annual plan for review
Plan, Review and updating will be done on following basis:
•  Customer /In –house complaints.
•  Process Change
•  ECN/PCN
Revised Date will be updated in Control Plan.

Coherence
QA Head will prepare the Coherence annual plan
Coherence will be studied between Drawing, PFD, PFMEA, Control Plan, Incoming and in process, Final Inspection stage and recording sheet.

ADVANCED PRODUCT QUALITY PLANNING (APQP)


ADVANCED PRODUCT QUALITY PLANNING (APQP)


Scope:
The following procedure will be carried out in below conditions
1.  Any Similar part which has not produced earlier
2.  Any Similar part which has produced earlier
3.  Existing Product ECN /PCN
4.  Plant location Change.
5.  If part is from Automotive Customer
•  Entire Procedure of product development is carried out as per guidelines provided in the AIAG Reference Manual: APQP (2nd Edition)
•  The activity to be done with respect to respective responsible person are defined in APQP Matrix.
•  APQP Timing plan shall be made based on category defined in APQP Matrix
•  APQP Timing plan shall be made based on category defined in APQP Responsibility Matrix
•  Review Frequency: CFT: Every 15 days
Top Management along with CFT: Monthly and at phase end. During those review customer milestones shall be discussed
•  NPD Head will be over all responsible for implementation of the requirements given in this procedure. However specific responsibilities of various departments for implementation of this procedure of this procedure are defined hereunder.

Initiate Phase I i.e. Plan and Define

1.  Receive customer enquiry / documents / sample / drawing.
2.  Enter details in New Development Log Book/ECN Logbook.
3.  Review customer documents& resolve technical issue with customer.
4.  Use best practices & take benefit of TGR / TGW and Past Defect History Records.
5.  Supplier Selection (Raw Material , Tooling , Instrument and Gauges requirement)
6.  List of Equipment, Tooling, Instrument Required/Resource Planning
7.  Perform Risk Analysis for the Project and Capture the same in Risk Analysis Sheet
8.  Define customer requirements, including special characteristics & Do Feasibility Study with CFT.
9.  Prepare Quotation, submit to customer & resolve commercial issues.
10.  Follow up with customer if no response is received within a week.

Initiate Phase II i.e. Product Development

1.  Receive Development Order from the customer/LOI.
2.  Contract Review
3.  Prepare APQP Timing Plan to be prepared and get approval of top management
4.  Prepare Tool Development Plan.
5.  Prepare Fixture Development Plan.
6.  Prepare Instrument/Gauge and Testing Equipment Plan

Initiate Phase III i.e. Process Design & Development

1.  Prepare Process Flow Chart.
2.  CFT will Prepare PFMEA Matrix.
3.  CFT will Prepare PFMEA.
4.  Prepare Pre-launch Control Plan.
5.  Prepare & display necessary Work Instructions Inspection Standards for each production stage.
6.  Prepare Packing standard
7.  Procurement of Material
8.  Training to concerned person for trial run.
9.  All the material should move with Blue route card.
10.  Conduct T – 1 Trial Run
11.  Submit IPP Report along with the samples
12.  Receive Sample Approval report from Customer if
13.  Follow up with customer for the same
14.  Follow up with customer if no response is received within a week.
15.  Conduct T-2, T-3…. Tn  Trial Run, if required in case of any Customer Complaint.
16.  Plan for MSA and SPC for the Parts

Initiate Phase IV i.e. Product and Process Validation

1.  Training to concerned person for pilot Lot
2.  Start producing the Pilot Lot / Initial Parts.
3.  Perform Measurement System Analysis Process Capability Study as required.
4.  Conduct Process Audit (To be carried in process in which CC is maintained.)
5.  Check pilot lot as per the Pre-launch Control Plan& prepare Layout Inspection Report and prepare all PPAP document, including PSW.
6.  Evaluation of Packing Standard
7.  Submit pilot lot &PPAP documents to customer for approval.
8.  Follow up with customer if no response is received within a week

Initiate Phase V i.e. Feedback Assessment & Corrective Action

1. Receive Pilot Lot Approval Documents from customer & hand over to Quality.
2. Record all quality issues in PDCA Analysis Sheet faced In-house & at Customer End during Trials. Analysis to be done in CAPA sheet.
3. Prepare TGR / TGW.
4. Prepare APQP Sign Off after SOP at Customer end for Mass Production Sheet& hand over all documents to Production
5. Start Production under IPC & monitoring the production activities closely for each production lot.

Monday, May 27, 2024

FAILURE MODE AND EFFECTS ANALYSIS (FMEA)


FAILURE MODE AND EFFECTS ANALYSIS

Entire process of FMEA development, either design or process, uses a common approach to address as per the guidelines provided in the AIAG Reference Manual: IV Edition of FMEA.

NEW PRODUCT DEVELOPMENT OF PROCESS FMEA:  
Prepare a flow chart. This Flow chart should identify the
Product/ Process Characteristics associated with each
operation as finalized by CFT at the time of product
realization process.

Carry out risk assessment and conduct FMEA for all high risk Process steps. Copy of Flow Chart/ risk assessment should accompany the process FMEA.

Document the Potential failure and their consequences in the FMEA format. The usage of this format is given below with number correlating with number given on the format.

Following items to be considered while forming FMEA
•  Troubles in the past of Similar Part.
•  Defect items expected (PFMEA Matrix)
•  Defect items unable to capture at customer end
•  Defect items difficult to repair
•  Defect Matrix (Past 6 months’ data)
•  PFD
•  Customer Specific Requirement
•  Similar Part PFMEA
•  AIAG SOD Ranking

FMEA NUMBER - Enter the FMEA document number as per the numbering system described

ITEM – Enter the name and number of the part for which the process is being carried out.

PROCESS RESPONSIBILITY – Enter the Section / Department responsible for maintaining the process

PREPARED BY – Enter the name of the CFT leader and his signature


FMEA DATE – Enter the date when the original FMEA was compiled and the revision dates as and when the FMEA undergoes revision

CORE TEAM - Enter the names of Team members, their department and designation

PROCESS FUNCTION / REQUIREMENT -Enter a simple description of the process/operation being analyzed. Indicate as concisely as possible the purpose of the process or operation being analysed.
Example: - Press Operation

POTNTIAL FAILURE MODE – Enter the Potential failure mode for each process requirement separately by asking how the process/component can fail to meet the process requirement. The assumption is that the failure could occur but may not necessarily occur.
Example – Dia more, Dia less etc.

POTENTIAL EFFECT OF FAILURE – Enter the Potential effect of failure i.e., the effect of failure mode on the customer. The customer may be next operation or end user. Each must be considered when assigning the Potential effect of failure.
Example: For next operation turning, Customer Dissatisfaction etc.

SEVERITY (S) – Severity is an assessment of the seriousness of the effect of the potential failure mode to the internal or external customer. Severity is estimated in 1 – 10 scale as per FMEA severity reference table.

CLASSSIFICATION- Indicate the classification of special characteristics by the use of Symbol finalized by CFT / customer

POTENTIAL CAUSES / MECHANISM OF FAILURE- List to the extent possible, each and every conceivable failure causes assignable to each potential failure mode. Describe the cause in terms of something that can be corrected or can be controlled.
Assume all inputs are conforming to specification and process design of the product is acceptable during first interaction.

Ambiguous phrases like operator error, machine malfunction, etc., should be avoided. List out first level causes like Man, Machine, Method, Material etc., and write the root cause under each first level causes. Typical examples are Tool Wear, Improper set up, inaccurate gauging etc.
For failure, which has no direct relation to a cause, a cause and Effect diagram should be drawn.
While generating the causes, the potential failure only should be considered not the effects. Refer the historical Quality records to verify that all causes occurred are listed.

OCCURANCE (O) - Occurrence is how frequently the specific failure cause is projected to occur. Estimate the likelihood of occurrence of a cause on 1 to 10 scales as per FMEA Manual. Only occurrence resulting in the failure mode should be considered for ranking. Failure detecting measures should not be considered here.

CURRENT PROCESS CONTROL- Enter the proposed or current controls that detects the failure mode, should it occur, or prevent the failure mode for occurring.
The types of Control are:

TYPE 1 Prevent the cause or failure from occurring. (e.g. Mistake proofing)
TYPE 2 Detect the cause mechanism and lead to corrective action (e.g. SPC charts, set up approval etc.)
TYPE 3 Detect the failure mode (e.g. 100% inspection at stage or during the subsequent operations)
The control should be written against each cause listed in potential causes Column. If no control on the causes, then write “No Control’.

All Controls listed should be presently being practiced in the process and should be referred in any of the documents such as Control Plans, Work Instruction etc.

Estimate the detection ranking on 1-10 scale from FMEA Manual. The controls such as control charts, 100% inspection, and sampling done on statistical basis is valid detection control and deserves low ranking. The low occurrence does not deserve low detection ranking.

Random Quality checks are unlikely to detect the existence of an isolated defect. Sampling done on a statistical basis is a valid detection

RISK PRIORITY NUMBER (RPN) – The risk priority number is the product of Severity, Occurrence and Detection.

RPN = (S) X (O) X (D)

The RPN will be in between 1 to 1000. For higher RPN, the team must undertake efforts to reduce the risk through corrective actions. In general, regardless of the resultant RPN, special attention should be given when the severity of potential effect of failure is high.

RECOMMENDED ACTION- After completion of the steps described above, the RPN are to be analyzed in Pareto fashion to identify the priority for control.
To reduce the probability of occurrence, process revisions are required.
The actions recommended should be to prevent / eliminate the causes to reduce the occurrence ranking. The preventive techniques, such as, mistake proofing methodology, SPC method to be considered.

RESPONSIBILITY AND TARGET TO COMPLETE - Enter the department / individual responsible for the recommended action and the target date of completion.

ACTION TAKEN- After an action has been taken, enters the brief description of the action taken and effective date.
ACTION RESULTS – After the corrective action taken, the Team Leader is to verify the action for implementation. Estimate and record the resulting S, O, D ranking. Calculate the RPN. If no action is taken leave the related ranking column blank. 
All resulting RPN should be reviewed and if further action is considered necessary, repeat step-18 through step 21

FMEA REVIEW AND UPDATING:  
QA Head will review FMEA once yearly basis as per plan.

Action shall be taken on
• Top 1 RPN
• Severity 9 & 10 resulting in RPN >100

FMEA is a living document and should always reflect the latest changes and incorporation in the process. 

FMEA should be reviewed whenever
• Process is changed, 
• Engineering Change
• In-house complaint
• Customer Complaint

Whenever FMEA is reviewed, the concerned process related documents like Control plans, Stage Drawings, Work Instructions etc. are to be reviewed and updated if required.

Sunday, May 19, 2024

IATF 16949:2016 AUTOMOTIVE QUALITY MANAGEMENT SYSTEM


What is IATF 16949:2016?

IATF 16949:2016 is the International Standard for Automotive Quality Management Systems. 

This standard was jointly developed by The International Automotive Task Force (IATF) members and submitted to the International Organization for Standardization (ISO) for approval and publication.

IATF 16949 emphasizes the development of a process oriented quality management system that provides for Continual Improvement, Defect Prevention and Reduction of Variation and Waste in the Supply Chain. The goal is to meet customer requirements efficiently and effectively.


Who are the IATF?

The IATF is a group of automotive manufacturers and their respective trade associations, formed to provide improved quality products to automotive customers worldwide.


Who is it applicable to?

The standard is applicable to any organization that manufactures components, assemblies and parts for supply to the automotive industry.