Saturday, June 15, 2024

IATF16949 {7.2.1} Competence—supplemental - Explained

7.2.1 Competence—supplemental
The organization shall establish and maintain a documented process(es) for identifying training needs including awareness(see Section7.3.1) and achieving competence of all personnel performing activities affecting conformity to product and process requirements. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements.


EXPLANATION - 

Organization must have procedure for Training Needs Identification and Training  for all Employees.

Training Needs Identification - Identification of Training Topics by Department Head for his team members which is required to perform tasks.


Employee should have competency regarding Product and Process which he/she dealing with in an organisation. He/she should be qualified to perform tasks for which he/she was appointed by Organisation.
If he/she is not qualified then Organisation should have plan to qualify them.

Following are some examples of Training Procedure,

NEW JOINEE SELECTION AND TRAINING 

1. Manpower request shall be generated by respective department and informed to HR

2. Based on the Competency Matrix the new employee shall be recruited.

3. HR to update the List of Employee on recruitment

4. For staff, training related to HR and department specific training shall be provided and record to be maintained in Induction Training for staff

5. For operator and inspector, Training related to HR shall be given. Further training shall be provided till the level for which they are recruited as per skill evaluation criterion

6. Skill evaluation shall be done for operator and inspector within 5 to 10 days based on skill evaluation paper.

7. Passing Criterion is 60%

8. If Fail then Retraining shall be given immediately

9. If Pass Update skill matrix in soft

10. Conduct the trainings as per training plan and record the details of imparted training in training attendance record. 

11. Update Training Attendance details in Employee Training History sheet to generate employee wise history for given trainings.

PROCEDURE OF TRAINING FOR STAFF

1. HR shall prepare the list of training topics with discussion with respective department head and identify the TNI (Training Needs Identification) once per year in TNI format

2. Employee shall self-evaluate the training need in TNI form and submit to HOD

3. HOD shall verify the TNI Identified by employee and make correction/suggestion and submit TNI to HR.

4. HR shall prepare the Annual Training Plan for Staff based on TNI.

5. As per the training plan,HR shall ensure all training are conducted by DH & Respective Person and record the detail in Training Attendance sheet.

6. If case of External Training, HR will hire external consultancy as per requirements.

7. Effectiveness of the training shall the self-evaluated immediately after the training by employee and 7 to 15 days after the training by respective HOD in Effectiveness cum Feedback Form and declare if retraining required or not.

8. In case of failure in either case, Retraining shall be planned.


PROCEDURE OF TRAINING FOR OPERATORS

1.  TNI shall be plotted by respective HOD for all operator and inspectors based on the skill matrix once per year in TNI form and submit to HR

2.  HR shall prepare the Annual Training Plan for operator and inspector based on TNI

3.  As per the training plan, HR shall ensure all training are conducted by DH & Respective Supervisors and record the detail in Training attendance sheet

4.  After completion of syllabus, the effectiveness of training shall be checked within 7 to 15 days by respective supervisor in Training effectiveness sheet.

5.  Passing Criterion is 60 %

6.  In case of failure retraining shall be planned by HR in annual training plan

7.  If Pass then the skill matrix shall be updated in soft.

PROCEDURE FOR SKILL MATRIX AND EVALUATION

1. Skill Evaluation Criterion to be made for all the operator and inspector level wise with minimum required level defined for working on machine or workstation

2. Based on the criterion the skill matrix shall be plotted through Evaluation Paper.

3. Passing criterion is 60%

4. Skill Evaluation Plan to be made to verify the skill of operator and inspector on timely basic.

For Operator : 6 Month
For Inspector and Special Operator : 3 Month

5. In case of failure retraining shall be planned

6. List Displayed in HT department. Skill Evaluation Plan to be made to verify the skill of operator and inspector on timely basic.

7. Special Operator : 3 Month

8. Skill Matrix shall be updated at a frequency of 6 month in hard.

Please comment if you have any query.

Friday, June 14, 2024

IATF16949 {8.4.2.3.1} Automotive product-related software or automotive products with embedded software - Explained

IATF16949 {8.4.2.3.1} Automotive product-related software or automotive products with embedded software

The organization shall require their suppliers of automotive product-related software, or automotive products with embedded software, to implement and maintain a process for software quality assurance for their products.
A software development assessment methodology shall be utilized to assess the supplier's software development process. Using prioritization based on risk and potential impact to the customer, the
organization shall require the supplier to retain documented information of a software development capability self-assessment.

EXPLANATION: 
Organization should have procedure for Quality Inspection of their Supplier who is providing automotive products-related software or automotive products with embedded software.

Embedded Software -  A software/firmware which is installed in product to connect electronics system and mechanical system. 

Organization should do supplier assessment and risk analysis to check  software development capability.

You can do by following this procedure 

PROCEDURE FOR EMBEDDED SOFTWARE MANAGEMENT 

Scope: This procedure describes the method of control of Embedded Software

1. Define Requirements necessary for Embedded Software development like Input Requirements, Output Requirements, Verification and Validation of Software.

2. Identify software development capability and ensure capability self-assessment before start of any software development.

3. Prepare List of Software with current version details.

4. Define quality program to ensure checking and validation of embedded software

5. Define and ensure necessary competence required for software development and its quality checking

6. Define and ensure necessary infrastructure required for software development and its quality checking.

7. If software development is outsourced, then ensure all above requirements at supplier placed during supplier evaluation.

8. Get all necessary evidence from Supplier before start of software development like evidence development capability assessment, necessary infrastructure, manpower, testing and validation facilities.

9. Ensure that the current software version in revision control matches the software that is in use. 

10. Maintain the history of the revisions of software.

11. All software must be password protected and prevent inadvertent changes or tampering by restricting the ability to make changes only to authorized personnel.

Please comment if you have any query.

Thursday, June 13, 2024

ROADMAP FOR IMPLEMENTATION OF IATF 16949:2016

ROADMAP FOR IMPLEMENTATION OF IATF 16949:2016

A. TRAININGS 
1  Awareness Training to a Employee including Contracted people in batches
2  Internal auditing Training
3  Departmental scope and applicable requirements
4  Customer Specific Requirements
5  Training about Basics of Core Tools (SPC, FMEA, MSA,PPAP, APQP), Control Plan, Cost of Poor Quality,OEE,MTTR, MTBF

B. DOCUMENTATIONS 
1  Departmental Process Manuals
2  Quality Manuals
3  Process Wise Turtle chart preparation & Training
4  New Formats as per the requirements.
5  Modifications in exisiting formats if any
6  Formation of SOP


C. IMPLEMENTATIONS 
1  To ensure preparations of all records
2  To ensure preparations of records as per the Manuals
3  To conduct monthly review
4  To make necessary changes in the format
5  12 Month Data preparations.
6  Various action plan preparations.

D. INTERNAL AUDIT 
1  To conduct Internal audit with the trained internal auditor
2  To report the findings of audit
3  To close the Audit findings.


E. MRM (MANAGEMENT REVIEW MEETING) 
1  To ensure data preparations before MRM
2  Pre meeting before MRM to create awareness and methodology of MRM
3  To participate in MRM
4  To help for the Minutes preparations


F. CERTIFICATION AUDIT 
1  Fill the application form after completion of 1st Internal Audit and MRM
2  To get the quote from Various CB’s
3  To finalize the CB.
4 Coordination with CB for audit.
5 Planning of Stage One Audit
6  Close all Observations of Stage One Audit
7 Planning of Stage 2 (Final) Audit
8  Close all Observations of Stage 2 (Final) Audit
9 Follow with Certification Body for Certificate

Saturday, June 8, 2024

PROCEDURE FOR VERIFICATION AFTER MAJOR SHUTDOWN

PROCEDURE FOR VERIFICATION AFTER MAJOR SHUTDOWN

If any planned or unplanned shutdown is more than 30 Days then verify the production facility.

 Ensure that the production process outputs are complying with the necessary product requirements as per the control plan or process plan as necessary and as applicable depend on shut down time and nature of shutdown 

by following ways,
1. Job Set up Approval Report
2. By checking plant facility and layout condition
3. By revalidating the processes.
4. By doing manufacturing process audit
5. By doing product audit
6. By submitting sample lot to customer for verification 
7. By taking functional feedback from customer for sample lot.
8. By doing Machine fitness test if any.  



Take necessary approvals from concern customers like resubmission of samples, PPAP report, SPC report or any audit from customer as per the customer specific requirements etc. after the shutdown is over.

PROCEDURE FOR JOB SET UP APPROVAL

PROCEDURE FOR JOB SET UP APPROVAL

Ensure that the setting layout are accessible and understood by the concerned operators.
  

Carry out component setting as per Operational Control Procedure.

 
Carry out Job set up verification on the following occasions:
a.  Initial run of the job (First piece approval)
b.  Daily at Start of Production
c.  Different job is to be taken up
d.  When the time period between 2 runs is more than 24 hours.
e.  Also verify the setup in case any major maintenance is carried out in the machinery.
f.  Whenever material change over takes place i.e. whenever material with from different supplier is processed.


Continue the operation in case the job setup inspection is conforming to the requirements.


In case the job setup inspection is not OK, then stop the machine, investigate the root cause of the non-conformity, take disposition action & take trial run and follow the approval process.


Keep job set up approved pieces separately and compare with the last piece of the shift and maintain the record of last piece inspection if feasible.

PROCEDURE FOR EMPLOYEE RECRUITMENT

PROCEDURE FOR EMPLOYEE RECRUITMENT

Requirement of man power for Assistants, Inspectors, Incharge and above level is received from concerned department heads through e mail.

Update the list of required employment.

The requirement is matched with the existing qualification matrix and the qualification requirements are identified.

In case of special qualifications required, it is provided by the concerned department and pre approved from Top Management.

Corrosponding CV’s are collected from placement agencies/ other sources.

The suitable candidates are lined up for interview by the Interview Team.

If the candidate is found suitable, he/she is given an Appointment Letter.

 If Appointment Letter is accepted , the date of joining is finalized.
 
Appointment letter is given to the new employee.

Do not appoint the personnel below 18 years.

A personal file is prepared for the new employee containing details of Qualification, Experience and other related documents. 

Following list while employee recruitment,

ID PROOF ( ADHAR CARD)
AGE PROOF
QUALIFICATION CERTIFICATE

IATF16949 {6.1.2.3} Contingency Plans

IATF16949 {6.1.2.3} Contingency Plans

The organization shall:
 
a) identify and evaluate internal and external risks to all manufacturing processes and infrastructure
equipment essential to maintain production output and to ensure that customer requirements are met;

b) define contingency plans according to risk and impact to the customer;

c) prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures. (alsoseeSection8.5.6.1.1); interruption from externally provided products.
processes, and services; recurring natural disasters; fire; utility interruptions; labour shortages; or infrastructure disruptions;
 
d) include, as a supplement tothe contingency plans,a notification process to the customer and other interested parties for the extent and duration of any situation impacting customer operations;

e) periodically test the contingency plans for effectiveness(e.g simulations, as appropriate);

 f) conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team including top management, and update as required;

g) document the contingency plans and retain documented information describing any revision(s). including the person(s) who authorized the change(s).

The contingency plans shall include provisions to validate that the manufactured product continues to meet customer specifications after the re-start of production following an emergency in which production was stopped and if the
regular shutdown processes were not followed.

Explanation: Please follow below Procedure for Making Contingency Procedure 

HOW TO IDENTIFY CONTINGENCY PLAN

Identify internal as well as external risks involved in manufacturing processes as well as minimum essential infrastructure required to get the required production to fulfill the customer requirements.


Identify the possible contingency can occur like
1.  Power Failure
2.  Labour Shortages
3.  Key Machinery Failure
4.  M&M Equipments failure
5.  Natural Disasters
6.  Interruption due to External provided sources
7.  Infrastructure disruption


Decide suitable contingency plan wherever possible for possible contingency.


If contingency plan is not available then decide suitable actions like,
1.  Deviation from customer on delivery
2.  Safety stock availability
3.  Reduce Lead time to rectify the contingency


Alternative work if any, communicate contingency plan within the organization by suitable ways i.e.
1.  By giving Internal Trainings
2.  By providing Copy of contingency plan
3.  By fixing the responsibilities to perform


If customer requirements, communicate contingency plan by giving one copy or as per the customer requirements.

How to test Contingency Plan & Review

Decide suitable action and frequency to test the contingency plan based on past experience of contingency occurred and criticality of contingency and existing control of contingency actions decided.


For any contingency actions is linked to external providers services or operation or activity, inform supplier about the testing plan and requirements.


If any contingency occurred and handled as per the contingency plan, records of same can be maintained as contingency testing record.


Keep record of contingency testing and update the contingency plan as necessary.


Review the contingency plan at least once in a year by forming a team from different sections like Production, Quality, Purchase, top management, HR etc. based on

1.  Contingency tested
2.  Contingency occurred and response
3.  Changes in customer requirements
4.  Changes in infrastructure
5.  Changes in manpower

Maintain the record of review and update the contingency plan as necessary.