IATF16949 {7.1.4} Environment for the Operation of Processes

IATF16949 {7.1.4} Environment for the Operation of Processes

See ISO 9001:2015 requirements
The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.

NOTE A suitable environment can be a combination of human and physical factors, such as:
a) social (e.g. non-discriminatory, calm, non-confrontational);
b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).
These factors can differ substantially depending on the products and services provided
.
NOTE Where third-party certification to ISO 45001 (or equivalent) is recognized, it may be used to demonstrate the organization's conformity to the personnel safety aspects of this requirement.

7.1.4.1 Environment for the operation of processes — supplemental

The organization shall maintain its premises in astateoforder, cleanliness, and repair that is consistent with the product and manufacturing process needs.

Explanation - Work Environment means environment surrounding of work place/shopfloor

PROCEDURE FOR WORK ENVIRONMENT

6.1 Raw Material/finished/in-process/suspect/non-conforming products or material are stored at designated locations with visual identifications 

6.2 Part/Raw Material which has crossed the specified Shelf Life are identified and scrapped / disposed. 

6.3 The calibrated M & M Equipments / gauges / fixtures / stencils are stored in the designated areas.

6.4 The shop floor is marked for the gangways.

6.5 The gangways are always clear/through and no product/ material/ scrap is stored in the gangways.

6.6 All electrical panels/switches are suitably marked, and no loose wiring is done.

6.7 The fire extinguishers/ first aid box is available at the specified location.

6.8 The floor / wall / roof are clean and the dust / lob webs are frequency cleaned as appropriate.

     

07 Conduct the house keeping audit once in a month and determine the housekeeping index

08 Initiate & implement corrective actions as appropriate

IATF {8.6.2} Layout Inspection and Functional Testing

IATF {8.6.2} Layout Inspection and Functional Testing

A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans. Results shall be available for customer review.

NOTE 1Layout inspection is the complete measurement of all product dimensions shown on the design record(s).

NOTE 2 The frequency of layout inspection is determined by the customer.

Explanation - Please refer below Layout Inspection Procedure

PROCEDURE FOR LAYOUT INSPECTION AND FUNCTIONAL TESTING 

A Preparation

01 Review the Monthly Production Plan

02 From Monthly Production Plan, Identify the product for Layout Inspection

03 Refer to the contract review documents and determine if the customer has specified any frequency for the Layout inspection and functional testing.

04 If customer has not specified any frequency, then decide the same as follows.

4.1 If in the whole year the product is to be produced only once (i.e. only is one lot), the Layout Inspection & Functional Testing shall be carried out once in a year

4.2 If the product has been scheduled so as to produce one lot per month, then Layout Inspection & Functional Testing shall be carried out at Least Once in a month for each category.

05 Prepare Layout Inspection Plan taking into consideration the requirement of step 03 & 04.

06 Refer to latest Drawing/ Engineering Specifications /Standard of the product or BOM if Drawing/ Engineering Specifications /Standard is not available  

07 Scrutinize the drawing and list down all dimensions / parameters to be verified/ inspected on the product

08 Codify the dimensions/parameters and make a list of all dimensions on product drawing /standard/BOM

09 Look for special notes/instruction on the drawing for the functional testing.

10 Identify the Calibrated Instruments required for the Inspection.

11 Ensure that they are calibrated as per the calibration plan & that the MSA studies are carried out

12 At the end of Month, review the plan for the layout inspection for the completion, if any activity is not covered, consider the same during planning for the next month.

B Inspection 

01 Select 5 components at random from the Finished Goods Storage Area.

02 Carryout the inspection of parameters/dimensions as per the list and note down the actual readings.

03 Note down the variations with respect to the drawing.

04 Compare with the tolerances specified by the Customer.

05 Report the non-conformities to Concerned Person.

06 Initiate corrective action

07 Verify the implementation of CA

C Functional Testing

I Preparation 

01 Identify the facilities required for functional testing of the Product.

02 If it is not possible to carry out the specified testing in house, then develop supplier for the same.

 

03 If the customer has the required facilities, request customer through concerned Person to make the facilities available.

II Testing

01 Carry out the functional testing for 5 Nos. Product

02 Record the observation and compare with the Specified Requirement

03 Report the non-conformities to Concerned Person.

IATF16949(ISO9001) {7.5.3} Control of documented information

IATF16949(ISO9001) {7.5.3} Control of documented information

7.5.3.1 and 7.5.3.2
See ISO 9001:2015 requirements.
7.5.3.1
Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentially ,improper use or loss of integrity).

7.5.3.2
for the control of documented information the organization shall address the following activities, as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility
c) control of changes (e.g. version control)
d) Retention and disposition. 

Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be Identified as appropriate, and be controlled.

Documented information retained as evidence of conformity shall be protected from unintended alterations.

NOTE Access can imply a decision regarding the permission to view the documented information only, or the Permission and authority to view and change the documented information.

Explanation - Read below Procedure for Explanation 

CONTROL OF DOCUMENTED INFORMATION IN IATF16949/ISO9001 QUALITY MANAGEMENT SYSTEM

Identification of documents

Level 1-Quality System Manual-QM
Level 2- Quality System Procedures-QSP
Level 3- Product Quality Documents/ Work instructions /checklists
Level 4- Forms /Formats as per Master list of records.

Design and Identification of each page of the Quality System Manual:
While designing this manual, the facility is provided to identify with Section Number having each page separately.  For every ‘Section’ the new page number starts and ends when that ‘Section’ ends. The information written in the top portion of each page states the content of the standard requirements clause wise as a Title. 

 
Header contains following information …
Issue No. & Date:  The latest Issue of the companies Manual with its date of application.
Rev. No. & Rev. Date: The latest revision status of the each ‘Section’ with its date of application.
Section No. & Page No.: It is Quality Manual Section number relevant to the particular information. The exact number of page ‘out of total pages of that Chapter’.
IATF 16949 Clause: It is Main / Sub clause relevant to the particular information in the section as per IATF 16949:2016 standard.
Footer contains following information …
Prepared, Approval, Controlled & Issued and Signatures

Quality System Manual holder:
System Coordinator maintains the Master copy of this ‘Quality Manual’ whose each page bears a stamp “MASTER COPY” in Red colour ink.

System Coordinator takes photocopy of the master copy and sends it to the controlled copy holders listed in this Quality Manual, after stamping each page with “CONTROLLED COPY” in Red colour ink.

System Coordinator issues the controlled copy to Controlled copy holder. The respective controlled copy number is identified on the covering page of this manual.

Controlling changes to Quality System Manual:

Changes to the Quality Manual are made as required for maintaining the integrity of the quality management system, when they are planned and implemented to the quality management system. 

SC follows steps mentioned below:

Receive the suggested changes in Document change request note (DCRN).

Assess for integrity of QMS, adequacy to the specified requirements and take approval from concerned approving authority. 

Carry out necessary changes after approval.

Change the revision number to the next digit; also change the date for the whole section. Update revision sheet.

Quality Manual will be reviewed yearly as per Plan.

Obsolete Copy Control: 

Mark the obsolete pages from Master copy with ‘Obsolete Copy’ Stamp in ‘red’ color and retain them if required.

Remove obsolete pages of Quality Manual from controlled copy holders and tear.

Quality System Procedures:

Quality System Procedures includes Process Flow, Turtle Diagram and procedures required as per the need of Organization.

The methodology for the numbering system is as follows:

              QSP/XX or XXX/ YYY

Where,

 QSP stands for Quality System Procedure 

XX or XXX indicates the Department

YYY indicates the Sr. No. of the Process / procedure e.g. 001, 002, 003 etc.

Changes in Quality System Procedure/Documents: 

Receive the suggested changes through DCRN Format.

Assess for integrity of QMS, adequacy to the specified requirements and take approval from concerned approving authority. 

Carry out necessary changes after approval.

Change the revision number to the next digit; also change the date for the whole process / work procedure. Update revision sheet.

Put ‘MASTER COPY IF IN RED ‘ stamp on front side of each page.

Obtain the photocopy of the pages of documents.

Put ‘CONTROLLED COPY IF IN RED’ Stamp on each page of photocopied in front.

Issue the ‘Controlled Copy’ of the document to ‘controlled copy holders of the document, listed in Issue Register.

‘Controlled copy holder’ shall destroy all superseded copy of the document.

Revision History of the change shall be maintained in Amendment sheet.

Quality System Procedure will be reviewed yearly as per Plan.

CONTROL OF CSR, APQP, PROCESS FLOW, FMEA, PPAP, CONTROL PLANS :

a). Process Flow Charts, FMEA, Control Plan and PPAP, APQP, CSR etc. are prepared by the Quality Assurance Department Head / CFT and verification from CR / DIRECTOR / CMD and approved by the DIRECTOR/CMD. 

b) Identify the Departmental Turtle Diagram, Process Flow Charts, FMEA, Control Plan /Quality plan and PPAP needed for the quality management system and their application throughout the organization.

c). All SOPs, WIs & CPs will be reviewed along with the CTF Team & will be updated if required for the proper linkages.

Documents will be reviewed properly by respective process owners before issuing to shop floor.

CONTROL OF CUSTOMER SUPPLIED DOCUMENTS & CONFIDENTIALITY

Receive the customer supplied documents (may be in the forms of standards, Specifications in soft copy).

Verify the its clarity.

Put "CONTROL COPY"on it for issue

All Customer documents like drawings, standards hard copy controlls under DH(NPD) lock & key custody. 

Sign the confidential agreement to customer for non discloser aggreement about drawings, standards, specific information if required by customer.

CONTROL OF EXTERNAL ORIGIN DOCUMENTS 

Prepare a list of all standards identifying title and latest revision status.

Confirm the latest status through Book Supply Bureau, New Delhi, BIS Handbook or originating organization.

All the External Origin Documents will be reviewed on monthly basis or whenever there is any change in standards.

Issue photocopies only for training purposes or reference puposes by identifying them as “FOR REFERENCE ONLY “ . 

Update the list for, ‘addititon or deletion of standard in use’ and ‘latest revision status of the used standard.

CONTROL OF DOCUMENTS STORED IN COMPUTER:

Give the access to authorised person to use the computer.

Prepare the documents in the relevant directory of the subject.

Protect documents which are stored in computers by virus control software & with Password for access.

Fresh

Maintain a backup on the server on daily basis.

CONTROL OF FORMAT, REGISTER, LABEL, TAG, CHART, CATALOG AND LIST:

Define the Structure of Format, Register, Chart, List or Label for collecting the information systematically & Prepare the format, register, Label, Tag, Chart, Catagoue for new product etc. as per requirement, for the various process or procedure in cosultation with SC.

The methodology for the numbering system: 

Assign a unique number to Formats in the format :                           

(YYYor YY /XX or XXX/ZZ, Rev. 00)

(YY or YYY-Type of Document , XX or XXX- Department Abbreviation, ZZZ - Serial No,)

Assign revision status as : Rev. 00

If there is any changes in above documents , follow the procedure  and give the next revision 01,02 and so on.

e.g. FRM/SC/01 Rev.00 ---- is a ‘format number’ = 01 of System Coordinator having the ‘revision status’ = 00.

Maintain sample copy of each ‘latest format’ in use for verifying the latest revison status, by stamping it with stamp “SPECIMEN COPY”. 

Any new format introduced shall be identified with a number following the above system. 

‘Specimen Copy’ of the latest format shall be kept with SC with identification number for verifying the status.

Changes in Formats, Labels, Register, Charts, Tags etc.: - 

If it is necessary to make changes in Formats, Labels, Register, Charts Tags etc. based on modifications made in working practices or NCR’s in Internal / External Audits.

1. Prepare DCRN for changes to be made Obtain the approval to the changes to be made from DIRECTOR/CMD.

2. Carry out the Changes in the Required Formats/ Labels/ Tags. Also change the Rev. No. to next digit.

3. Revised respective dept’s “Master list of defined Formats / Labels / Tags / Stamps / Registers with respective revision no.

4. Take printout of changed Document. Put ‘Specimen’ stamp on each page.

Prepare a Master list of all formats, register, charts, list, labels in the various department identifying the ‘latest revision number’ and date.

Documents to be Retained : Record Control

1. Records are maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

2. Retention period of records are identified in master list of Quality Records.

3. The requirements Company, Statutory bodies, Regulatory bodies and Customer are considered while deciding retention period.

Decide for each quality record about, Indexing, Location for storage, Type of file, Access up to, Retention period, Disposal method.

Identify each file, register by pasting the ‘Record’ label noting the above details.

Keep quality record in such a way that they remain legible readily identifiable and retrievable.

Records received from suppliers / customers are also considered as records.

RECORDS / DATA STORED IN COMPUTER :

Records such as drawings, e mails, on line google docs. Also form a part of records in our organization.

Prepare and preserve the data which is prepared in the computer in respective file(s).

Protect this data by password and virus control software installed in the computer.

Maintain a backup copy on server. 

The backup is taken on server on a daily basis.

IATF16949(ISO9001) {8.5.6} Control of changes - Explained

IATF16949(ISO9001) {8.5.6} Control of changes

See ISO 9001:2015 requirements.

The organization shall review and control changes for production or service provision, to the extent necessary to

ensure continuing conformity with requirements.

The organization shall retain documented information describing the results of the review of changes, the

person( s) authorizing the change, and any necessary actions arising from the review.

8.5.6.1 Control of changes —

supplemental

The organization shall have a documented process to control and react to changes that impact product realization. The effects of any change, including those changes caused by the organization, the customer, or any supplier, shall be assessed.

The organization shall:

a) define verification and validation activities to ensure compliance with customer requirements;

b) validate changes before implementation;

c) document the evidence of related risk analysis;

d) retain records of verification and validation.Changes, including those made at suppliers, should require a production trial run for verification of changes

(such as changes to part design, manufacturing location ,or manufacturing process)to validate the impact of

any changes on the manufacturing process. When required by the customer, the organization shall:

e) notify the customer of any planned product realization changes after the most recent productapproval;

f) obtain documented approval, prior to implementation of the change;

g) complete additional verification or identification requirements, such as production trial run and new product validation.

Explanation - The organisation should follow Change Control Management Process as below 

CHANGE CONTROL MANAGEMENT

1.  As and when there are changes in product or process due to following situations or circumstances the change management procedure is followed and the changes will be communicated to customer and external interested parties with no undue delay.

2.  Change control management is applicable in case of following situations.


  The changes made in tooling or as a note on the design record and not covered by an engineering change.
  Production from new or modified tools (except perishable tools) including additional or replacement tooling.
  Production following rearrangement of existing tooling.
  Production from tooling and equipment transferred to a different plant location or from an additional plant location.
  Change of supplier for part non-equivalent material or services.
  Product and process changes related to components of production, productions manufactured internally or manufactured by external provider that impact fit, form, function or performance.
  Change in test, inspection method, new techniques (no effect on acceptance criteria)
  Regulatory Action
  Product Recall or when there is an event that could create adverse publicity
  Change of Suppliers
  Change of Manufacturing Process at Supplier End

3.  After receipt of engineering change Request from Customer, Supplier and internal then update the details in Product / Process Change Tracking Sheet.

4.  Review the changes feasibility as per feasibility review sheet. 


5.  Notification shall be given to customer through mail / Engineering change Request Cum Approval Note.

6.  Prepare the Engineering Change Timing Plan for execution of engineering changes

7.  After producing the samples carry out the Before and After study of samples according to Engineering Change Request.

8.  Submit the samples to the costumer with Before & After Study Report and PPAP if required.

9.  Submit Material Break Point Advice to Customer and receive approval of the same

10.  Receipt the approval or PSW from the costumer.

11.  Update the Engineering change summary in the Product / Process Change Tracking sheet.

12.  Make the changes in affected documents and formats wherever necessary.

13.  Dispose the stock which is as per specification before engineering changes.

Please comment if you have any query.

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.

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.

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