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SWARAN ENTERPRISES
LIST OF PROCEDURES
Procedure/Doc. No. Clause Ref. Name of Clause Rev. No. Date of
Implementation
SEQMSP/01 4.4.1.2 Failure Mode and Effect Analysis (FMEA) 02 01-04-2018
4. RESPONSIBILITY :
QA Head Representative is responsible for conducting various FMEA with the help of various Section Heads,
who are in charge of processes as explained above in Scope.
QA Head Representative is to ensure that FMEA is carried out before the event takes place i.e. before the
production start.
5. PROCEDURE :
Deptt. Representative makes the process flow chart. FMEA Teams are formed department-wise which includes
Deptt. Representative Prod., Dev. & Q.A. are assigned the responsibility for conducting FMEA’s. A typical FMEA
team will include, but not limited to:
Manufacturer / Manufacturing assembly material, quality maintenance also may be supplied and rep. From the
next process.
FMEA team looks at the following factors:
Identifies potential product related process failure modes.
Assesses the potential customer effects of the failure.
Past Defect/Lesson learn sheet
Pass through Characteristics
Defect, Difficult to Repair
Identifies the potential manufacturing or assembly process causes reduction or and identifies the process
variables on which to focus controls for occurrence detection of the potential failure conditions.
Develops a ranked list of potential failure modes, thus establishing a priority system for corrective action
considerations.
Documents the results of the manufacturing or assembly process.
The customer as identified in FMEA is normally considered as end user or next manufacturing process.
Flow Chart is used to assess the direction of flow and the risk involved during a particular process.
The various FMEA’s are filled in the same manner as referred in the manual for FMEA.
FMEA Assesses through their experience and available data, the following factors.
NOTE: Special approval is an additional approval by the function (typically the customer) that is responsible to
approve such documents with safety-related content.
A) SEVERITY (S) :
Severity is an assessment of the seriousness of the effect of the potential failure mode to the customer Severity
applies to effect only. The severity should be estimated on a ‘1’ to ‘10’ scale. The rating is done strictly as per chart
given in FMEA Procedure under heading of severity evaluation criteria. (As per AIAG Table)
B) OCCURENCE (O) :
Occurrence is how frequently the specific failure cause / mechanism is projected to occur. The occurrence ranking
number has a meaning rather than a value. Occurrence ranking number also is given as per the FMEA manual using
the evaluation criteria chart. Estimate the likelihood of occurrence on a ‘1‘to '10’ scale only occurrences resulting in
the failure mode should be considered for this ranking. .(As per AIAG Table)
C) DETECTION (D) :
Detection is assessed by the team based on the probability than the current process control will detect or not. The
potential cause / mechanism or the probability that the proposed process control will detect the subsequent failure
mode before the part / component used in manufacturing / process locations.
Detection ranking is given based on suggested evaluation criteria given in FMEA chart on ‘1’ to ‘10’ scale.
Random quality checks are unlikely to detect the existence of an isolated defect and should not influence the
detection ranking. Sampling done on statistical basis is a valid detection control. Do not automatically presume that
the detection ranking is low because the occurrence is low (e.g. when control charts are used), but do assess the
ability of the process controls to detect low frequency failure modes or prevent them from going further in the
process.(Refer Latest AIAG Table)
Through corrective actions. Regardless of the resultant RPN, special attention should be given when severity is high.
.(Refer FMEA Sheet)
Corrective actions are considered to reduce the RPN’s and in first phase all processes having FMEA’s Severity
Ranking above 8 (Eight) or RPN Value equivalent to 100 or more are considered for subsequent corrective actions.
Appropriate Statistical Meatheads are used to reduce the probability of occurrence severity ranking reduction is
possible only when design and or process revision is considered.
RECORDS
MASTER LIST OF FAILURE MODE & EFFECTS
F-QA-01 01-02-2018
ANALYSIS
1. PURPOSE: To eliminate the causes of actual or potential non-conformities in product, manufacturing process and
other processes of QMS.
2. SCOPE:
It includes corrective and preventive actions for non-conformities observed / anticipated during the internal audits ,
external audits, customer complaints and negative customer feedback or as suggested by anybody of company or
external.
3. PROCEDURE-
A. PREVENTIVE ACTION
Section In-charge analyses the following data to detect analyses and eliminate potential causes of non-conformities
related to product, process, environment and safety.
Determine Potential Non Conformities & their causes
Deptt Head investigate all possible causes and determine root cause of the problem.
Monitors the action taken and its effectiveness.
Records of results of action taken.
Utilizing lessons learned to prevent recurrence in similar processes
Management review meetings
Training Effectiveness and reviewing preventive action taken.
Communicate within the organization as required.
Note: MR also ensures that changes in related documents resulting from corrective and preventive actions.
RECORDS
2. SCOPE
The procedure relates to market related issues, financial planning, cost estimation, growth projections, plant and
facilities plans, cost objectives, human resource development, projected sales figures, quality objectives, customer
satisfaction plans, key Internal Quality and operational performance measurable, health safety and environmental
issues and related activities.
3. RESPONSIBILITY
Director is overall responsible to prepare and Departmental Heads are responsible for implementation.
4. DEFINITION: NIL
5. PROCEDURE
Top management shall ensure that quality objectives/ Business Planning 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). Collect the following data:
Market Related
- Sales projections based on existing customers requirement Annually
- Identification of prospective customers, new products/projects.
Communicate the Business Plan to all the concerned Departmental Heads to follow and develop their Action Plan for
implementation, Review the Business Plan during Management Review Meeting. Monitor progress towards
objectives and if needed update/revise the Business Plan
6. RECORDS
1. PURPOSE
To establish a system for maintenance of equipment for ensuring continuing process capability.
2. SCOPE
Applicable to all equipment used in production, which affect the quality of products.
3. DEFINITION: NIL
4. RESPONSIBILITY
a. HOD Maintenance is overall responsible for the implementation of this procedure for the maintenance of all
equipment’s.
b. Other specific responsibilities for individual activities are given under description.
5. DESCRIPTION
Preventive Maintenance
Identify the equipment to be covered under preventive maintenance
Prepare the list of equipment to be covered under preventive maintenance
Prepare maintenance check list for carrying out maintenance, along with the frequency for maintenance.
Carryout the maintenance using relevant check list and maintain record of the preventive maintenance.
Whenever a major repair/replacement is done on an equipment during maintenance keep records in the relevant
‘History Card’ of the equipment
Review the ‘History Card’ once in a year for deciding the frequency and preparing the maintenance schedule.
Allocate skilled personnel for carrying out preventive maintenance as scheduled
Breakdown Maintenance
Receiving information regarding breakdown/abnormality from the concerned sections and enter details in
breakdown records.
Investigate the cause of abnormality/ defect and carryout adequate maintenance for rectification.
Update the breakdown records for the section taken
Correlate preventive maintenance checklist with breakdown and amend preventive maintenance checklist if
required.
Analyze breakdown records for break down hours and defects. Take action to reduce the same.
Maintain inventory of spare part for preventive and breakdown maintenance.
Predictive Maintenance
Take daily plant round and see the machines for any abnormality and record the same in predictive maintenance
record.
Maintenance the machine as soon as possible ( before breakdown )
Investigate the cause of abnormality/ defect and carryout adequate maintenance for rectification.
Correlate preventive maintenance checklist with breakdown and amend preventive maintenance checklist if
required.
Approved by :Director Reviewed by : Head Quality
Signature: Signature:
SWARAN ENTERPRISES Rev No 02
AUTOMOTIVE QUALITY MANAGEMENT SYSTEM Rev Date: 01.02.2018
PROCEDURE MANUAL Page No 11 of 60- 11
(AS PER IATF 16949:2016) - of 60
Include predictive maintenance techniques, such as “LLF” (Look Listen Feel) mechanism to assess the
condition of the equipment.
Based on the frequency of maintenance prepare an Annual Maintenance Schedule.
Analyze predictive maintenance records for hours and defects. Take action to reduce the same.
6. RECORDS
F-MNT-01 LIST OF MACHINE 01-02-2018
ANNUAL PLAN FOR PREVENTIVE
F-MNT-02 01-02-2018
MAINTENANCE
PREVENTIVE MAINTENANCE CHECK SHEET
F-MNT-03 01-02-2018
V/S RECORDS
F-MNT-04 PREDICTIVE MAINTENANCE RECORD 01-02-2018
F-MNT-05 B-DOWN MAINTENANCE LOG BOOK 01-02-2018
F-MNT-06 GENERATOR LOG BOOK 01-02-2018
F-MNT-07 SPARE PART INVENTORY REGISTER. 01-02-2018
1.0 PURPOSE:
The purpose of this procedure is to provide a system, instructions and to assign responsibilities for evaluating
measurement systems.
2.0 SCOPE:
This procedure applies to measurement systems referenced in Control Plans and used for verification of Special
Characteristics of products and controlling for reference at all plant site in the Company. Corresponding processes.
Repeatability: - Repeatability is the variation in measurements obtained with one measuring instrument when used
several times by one appraiser while measuring the identical characteristics of the same part.
Reproducibility:-Reproducibility is the variation in the average of the measurements made by different appraisers
using the same measuring instrument when measuring the identical characteristics of the same part.
GRR or Gauge R & R: Combined estimate of measurement system repeatability and reproducibility
Variable Data: Data / Readings in which we can assign a particular number to measurement i.e. Measurement from V.
Caliper, Micrometer, Height Gauge So data observed in the form of :-Dia 25.4, Height- 118.2, Length- 250.6, Temp-
28°C etc.
Attribute Data: Only Decision can be concluded in the form of OK/NG, GO/NOTGO, and Qualify/Not Qualify etc. I.e.
Observation from Plug Gauge, Receiver Gauge, Visual Checking etc.
Number of distinct categories (ndc): This statistic indicates the number of categories into which the measurement
process can be divided. This calculated value should greater than or equal to 5. If this value is less than 5, it may indicate
a lack of discrimination as noted. The solution may be to use a measurement device that has a resolution to be at most
1/10th of the total process six sigma standard deviation instead of the
4.0 RESPONSIBILITY: It is the responsibility of Quality to ensure effective implementation of this procedure.
5.0 PROCEDURES:
Gage Requirements
The gage shall be calibrated in accordance with a documented calibration procedure
Graduations on the measurement device should be one-tenth of the tolerance range or smaller (for example of a
micrometer can measure to the nearest 0.001, it must not be used to measure a feature with a tolerance of less than
0.010). For critical characteristics this could restrict the one-tenth rule to the process range rather than the
tolerance range.
Measurements should be recorded to one decimal place smaller than the tolerance. (For example if the tolerance is
0.010 the measurements should be reported to a minimum of three decimal places- x.xxx).
Analog devices should be recorded to ½ the smallest graduation. For example if the smallest scale graduation on the
caliper dial is 0.001”, then the measurement results should be recorded to 0.0005”.
Statistical studies shall be conducted to analyze the variation present in the results of each type of inspection ( cover
all type instruments and both type of inspection – conducted by instruments and Visual ), measurement, and test
equipment system identified in the control plan
All measurement system referenced in the Control Plans is formally evaluated.
Approved by :Director Reviewed by : Head Quality
Signature: Signature:
SWARAN ENTERPRISES Rev No 02
AUTOMOTIVE QUALITY MANAGEMENT SYSTEM Rev Date: 01.02.2018
PROCEDURE MANUAL Page No 13 of 60- 13
(AS PER IATF 16949:2016) - of 60
Measurement system studies are conducted using the approach, procedures and acceptance criteria provided in
the Measurement System Analysis (MSA) Reference Procedure.
At a minimum, Repeatability and Reproducibility (Gauge R&R) study, using
The Average and Range method is conducted for variable measurement
Instruments; and Attribute Gauge Study is conducted for non-variable (Go /No-Go) gauges.
CONDUCTING AND REPORTING MEASUREMENT SYSTEM STUDY:
The Gauge R&R study (Variable Measurement System Study, Average and Range method.) &
Attribute Gauge study is carried out as per plan.
Variable method
Choose a minimum of 10 parts, 3 appraisers and 3 trials for the study. These parts should be chosen randomly from
current production representative parts. Identify (number) each of the parts. There are factors that could impact the
number of measurements taken. These could include: Criticality of the feature measured- for instance, critical
features may require additional measurements to increase the degree of confidence in the results. Additional parts
are preferred, over additional appraisers or replicates.
Part configuration or availability-large/bulky parts or low volume parts may dictate fewer samples and more trials
There are some measurements where the appraiser to appraiser effect (reproducibility) can be considered
negligible. These may include instances where a measurement device is loaded and secured by an automatic device.
If there is any uncertainty in regard to this, multiple appraisers should be used in the initial study.
For critical features, a work instruction should be developed that provides specifics on how to perform the
measurements. These specifics could include orientation of part, pressure applied to measurement device,
mastering frequency of measurement device.
The appraisers should be selected from those that would normally perform this type of inspection.
The inspections should be made in random order. The appraisers should be unaware of which numbered part is
being inspected.
Neither appraisers nor measurement devices should be changed during the duration of the study
Enter the results into Oshkosh worksheet labeled “GR&R” or a comparable template that is able to calculate using
the tolerance or ANOVA method.
GR&R Var (Tol): used for measurements that are not identified as critical
Attribute method:
Choose a minimum of (30 parts for the study). Between 40% and 60% of the parts should be “Good” parts and the
remaining should be “Bad” parts, as determined by an expert or other measurement method.
Identify (number) each of the parts.
For critical features, a work instruction should be developed that provides specifics on how to perform the
measurements. These specifics could include orientation of part, pressure applied to measurement device, or
distance and lighting to be used for visual assessments.
The appraisers should be selected from those that would normally perform this type of inspection.
The inspections should be made in random order. The appraisers should be unaware of which numbered part is
being inspected.
Enter the results into worksheet that is able to calculate a kappa value.
Interpretation of Results: Values of kappa greater than 0.75 indicate good to excellent agreement; while values less
than 0.40 indicate poor agreement
Are the standards for good and bad objective and well understood?
Could the testing environment be improved?
Result
If repeatability is large compared to reproducibility, the possible causes may be:
The instrument needs maintenance
The gage may need to be redesigned to be more rigid
The clamping or location of gaging needs to be improved
There is excessive within-part variation
ACCEPTANCE CRITERIA:
For variable instruments: Under 10% R&R is acceptable for any application;
10-30% R&R may be accepted depending on importance of application;
Over 30% R&R is not acceptable.
For non-variable (Go / No-Go) gauges: Acceptable only when all measurement decisions for the same part are in
agreement (based on Minimum 20 parts, two operators and two measurements per operator).
Note: MSA studies should focus on critical or special product or process characteristics .
7. RECORDS
4.0 Responsibility:
HOD (QA) is responsible for implementation of this procedure.
5.0 PROCEDURE:
Verification of equipment /gauges
HOD (QA) verifies Equipment / gauges/dies/ jigs and fixtures used for inspection, measuring & testing for its
conformity to the specified requirement, before acceptance.
Storage
Equipment / gauges/dies/ jigs and fixtures are kept safely either in store or user department, whichever is suitable.
Equipment / gauges/dies/ jigs and fixtures are stored under ambient condition, if specified, and maintained at all
times
Application and use
Wherever applicable and required Quality of the product is demonstrated by inspection and testing of the product
characteristics using equipment /gauges of known and verifiable accuracy.
The Equipment / gauges/dies/ jigs and fixtures are selected for use after ensuring their capability, suitability and
required accuracy.
Equipment / gauges/dies/ jigs and fixtures are always used in accordance with the guidelines / specification, given
by their manufacturer /supplier.
User is responsible for ensuring safe & proper use and control of the equipment / gauges.
Calibration/Validation
HOD (QA) is responsible for calibration/validation of the equipment /gauges.
All equipment / gauges, used in the company are identified and listed.
Equipment / gauges, not requiring calibration/validation are identified of such status by affixing a suitable sticker
on it, wherever possible & practical.
Equipment / gauges/dies/ jigs and fixtures requiring calibration/validation are further identified and listed defining
their capability, range /capacity, accuracy and other details (if any) in the terms of its intended use.
Equipment / gauges/dies/ jigs and fixtures are calibrated/validated on periodical intervals to ensure and maintain
their accuracy and reliability for continued fitness for use.
Frequency of calibration/validation is determined based upon the type of equipment its criticality of application,
frequency of use and expected rate of wear.
Calibration/validation of Equipment / gauges/dies/ jigs and fixtures is carried out either by external agencies or in
house as per the requirements.
Master equipment used for in-house calibration is calibrated by external agency traceable to the national /
International standards. Master equipment is used for calibration only. It is not used for normal operation and kept
Approved by :Director Reviewed by : Head Quality
Signature: Signature:
SWARAN ENTERPRISES Rev No 02
AUTOMOTIVE QUALITY MANAGEMENT SYSTEM Rev Date: 01.02.2018
PROCEDURE MANUAL Page No 16 of 60- 16
(AS PER IATF 16949:2016) - of 60
secured under control to preclude their use. Master equipment is identified suitably. Prior approval of HOD (QA) is
obtained to use Master meter for normal operation.
It is ensured that the equipment / gauges calibrated by external agencies are traceable to the National
/International standards, where available and practical.
Record of Calibration/validation is maintained.
Calibration/validation status of all the Equipment / gauges/dies/ jigs and fixtures (defining date of
calibration/validation, next calibration/validation due & calibrated by) is recorded.
Maintenance
HOD (QA) is responsible for maintenance of all the Equipment / gauges/dies/ jigs and fixtures used in the company.
Any Equipment / gauges/dies/ jigs and fixtures out of working order is defined of such status by affixing a suitable
sticker or any other suitable marking.
After maintenance Equipment / gauges/dies/ jigs and fixtures are re-calibrated as defined.
Record of maintenance of the Equipment / gauges/dies/ jigs and fixtures is maintained.
Whenever inspection & measuring equipment is found out of calibration the assessment/ review is done to verify
the validity of inspection and tests carried out by that instrument/equipment.
Laboratory requirements
Internal laboratory
An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the
required inspection, test, or calibration services.
The laboratory shall specify and implement, as a minimum, requirements for:
a) Adequacy of the laboratory technical procedures;
b) Competency of the laboratory personnel;
c) Testing of the product;
d) Capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.);
when no national or international standard(s) is available, the organization shall define and implement a
methodology to verify measurement system capability;
e) Customer requirements, if any;
f) Review of the related records.
NOTE Third-party accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate the organization's in-
house laboratory conformity to this requirement.
External laboratory
External/commercial/independent laboratory facilities used for inspection, test, or calibration services by the
organization shall have a defined laboratory scope that includes the capability to perform the required inspection,
test, or calibration, and either:
The laboratory shall be accredited to ISO/IEC 17025 or national equivalent and include the relevant inspection, test,
or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall
include the mark of a national accreditation body; or
There shall be evidence that the external laboratory is acceptable to the customer. for example, or by customer-
approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent.
The second-party assessment may be performed by the organization assessing the laboratory using a customer-
approved method of assessment.
Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available
for a given piece of equipment. In such cases,
Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to
government regulatory confirmation, if required.
6. RECORDS
F-QA-08 ANNUAL CALIBRATION PLAN ( EXTERNAL ) 2 01-02-2018
F-QA-09 ANNUAL CALIBRATION PLAN ( INTERNAL ) 2 01-02-2018
F-QA-10 EXTERNAL CALIBRATION CERTIFICATES 2 01-02-2018
F-QA-11 INTERNAL CALIBRATION CERTIFICATE 2 01-02-2018
F-QA-12 INSTRUMENT CALIBRATION HISTORY CARD 2 01-02-2018
F-QA-13 INSTRUMENTS ISSUE RECORD 2 01-02-2018
F-QA-14 DAILY CHECK POINTS OF INSTRUMENTS 2 01-02-2018
3. DEFINITION / ABBREVATION :
ETR: Employee Training Records
4. RESPONSIBILITY
The training section head is responsible for coordinating and controlling all the activities related to training.
Department Heads/Section concerned, is responsible for considering training effectiveness
The training records and skill matrix updation is maintained by MR/ HR / department heads.
New Induction trainings shall conducted and evaluated by HR/ MR.
Record of the same shall be maintained.
5. PROCEDURE
TRAINING NEEDS
Management / Deptt. Heads shall identify the general training needs for various levels of employees on the basis of
skill matrix to enhance the knowledge in the particular areas. Refer Skill matrix.
This procedure is applicable to all the employees whose work affects the product quality in the Organization.
ON-THE-JOB TRAINING
The organization shall provide on-the-job training which shall include
A. (Customer requirements training) for personnel in any new or modified responsibilities affecting conformity to
quality requirements,
B. Internal requirements,
C. regulatory or legislative requirements; this shall include contract or agency personnel. The level of detail required
for on-the-job training shall be commensurate with the level of education the personnel possess and the complexity
of the task(s) they are required to perform for their daily work. Persons whose work can affect quality shall be
informed about the consequences of nonconformity to customer requirements
TRAINING PLAN
HR & MR shall prepare a yearly Training Calendar for the centralized training. The Training Section will conduct the
training as per plan.
Dept. concerned /Section Head shall prepare a training plan according to the need for the departmental training & a
copy of Training Request Slip is forwarded to Training section.
Specific Needs Training Plan is circulated to all dept. heads .Pre intimation of centralized / External Training is given
by Training section before the training through a circular indicating the Topic, Faculty, date, time, venue. Dept. heads
decide the date and time of training with HR/MR as per the plan & inform the participants & conduct the training.
All new recruited employees are given induction training by dept. concerned /section head for Organization’s
'Quality Policy, Objectives and Organization’s General Policies besides on the job training wherever required.
Training is conducted by the In-house or External Training Faculty as required.
External & Internal Training records are maintained by MR & records are maintained in training records.
TRAINING EFFECTIVENESS
The effectiveness of training imparted to individuals is evaluated by HOD and their work performance results after
that at a defined frequency updated skill matrix also. Refer Training Records.
TRAINING GUIDELINES ARE DESCRIBED BELOW
Supervisor and above level of employees shall undergo need based training programs.
Operator level employees shall be given on the job training before being assigned independent job.
6. RECORDS
1. PURPOSE
To ensure that only current / relevant documents are used in the company.
2. SCOPE
All documents and data pertaining to requirements of IATF 16949:2016 such as quality manual, procedures, work
instructions and formats etc. including documents of external origin such as standards and customer drawings.
5. PROCEDURE
DISTRIBUTION, ACCESS, RETRIEVAL AND USE;
All documents are approved and re-approved for adequacy prior to release and are reviewed whenever necessary
through documents change note. All documents are new and revised are recorded in document issue register before
release.
It is available and suitable for use, where and when it is needed;
It is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).
XX:XXX:XXX
.F
Note- If any document have series of document than we assign number like this- :Doc abbreviation – running
serial No” ( like for work instruction= WI-01, 02, 03 etc .)
QMSM
6. RECORDS
1. PURPOSE
To demonstrate conformance to specified requirements and verify the effective operation of the quality
management system.
2. SCOPE
All Quality management system Records in hard copy or electronic media, which are maintained to demonstrate
conformance to specified quality requirements including pertinent quality records from the Supplier.
3. DEFINITION / ABBREVIATION: Nil
4. RESPONSIBILITY
M.R. to co-ordinate control of quality records in each function / department.
5. PROCEDURE
All quality records are identified, collected, properly stored and maintained by the respective dept. representative.
All quality records shall remain legible, readily identifiable & retrievable and stored in a suitable environment to
prevent damage or deterioration or loss to the record.
Quality records are adequate to provide evidence that quality system elements have been implemented and action
taken to correct the situation, if required.
Retention period for all records in each function. A list of Quality Records with their identification, location,
retention period and responsibility is maintained in Quality Records – by MR.
After the retention period, the quality records are disposed off by tearing or by retaining further suitably as per
needs, by respective dept. representative / MR.
Where agreed in the contract, the quality records are made available for evaluation to the customer & Regulatory
requirement.
Production part approvals, tooling records (including maintenance and ownership), product and process design
records, purchase orders , or contracts and amendments shall be retained for the length of time that the product is
active for production and service requirements, plus one calendar year, unless otherwise specified by the customer
or regulatory agency.
NOTE Production part approval documented information may include approved product, applicable test equipment
records, or approved test data.
All quality records are properly recorded, indexed and filed by user.
6. RECORDS
F-SYS-01 MASTER LIST OF DOCUMENTS 2 01-02-2018
F-SYS-02 MASTER LIST OF RECORDS 2 01-02-2018
4.0 RESPONSIBILITY:
The HOD (Quality/ Development) is responsible for implementation of this procedure.
5.0 PROCEDURE:
The Company has a well-defined system to ensure that the Customer requirements, design is reviewed and verified
and then conveyed to the manufacturing.
Responsibility, Organizational and technical interface
The Head (Quality/ Development) is responsible for design control. Against any design change by the customer or
in-house.
DESIGN CHANGES
Engineering Design Change Note is used for design control, to ensure changes are formally approved and
documented.
Design changes can be proposed by the user/ Customer and the same shall be reviewed and approved by the HOD
(Quality/ Development) before making the changes. The changes in design are incorporated by the HOD (Quality/
Development) after assuring that revised design is suitable to the customer.
Review should be completed within 10 working days of receipt of notification of engineering
standards/specifications changes.
Drawing Rev No and date shall be assigned to the modified drawings, after development of component as per
amendment / trial done.
Changes to the design are examined by Design department.
All changes to the design shall be recorded in the form of Engineering Change note (proposed change and after
changes, Design Verification and Review).
Development head also ensures the impact of design change on other documents like PFMEA, Control plans, process
sheet, and Inspection formats. PPAP is also revised and provided to customer.
Previous design records are also retained after marking obsolete with stamp of “obsolete copy”.
(Quality/ Development) head ensures that the revised documents shall be available with all concerned as required
and all previous documents shall be retrieved and destroyed and one copy of obsolete shall be retained for the
reference purpose only.
HOD (Quality/ development) maintains record of engineering documents issues and retrieved.
6.0 RECORDS
F-SYS-03 MASTER LIST OF DRAWING 2 01-02-2018
2. SCOPE:
This procedure is applicable to all contracts / orders.
3. DEFINITION / ABBREVIATION: Nil
4. RESPONSIBILITY:
The HOD Marketing is responsible for implementation of this procedure.
5.0 PROCEDURE:
The Company has a well-defined system to ensure that the Customer requirements are understood, verified and
then conveyed to the manufacturing.
Requirements specified by the customer shall include the requirements for
a) Delivery and post-delivery
b) Requirements not stated by the customer, but necessary for the specified or intended use, when known
Requirements specified by the organization;
c) Contract or order requirements differing from those previously expressed.
d) The specifications of the Product with special characteristics
e) Also included all applicable government safety and environmental regulations related to acquisition, storage,
handling, recycling, elimination, or disposal of material.
f) Customer-authorized waiver for the requirements stated
The organization shall ensure that it has the ability to meet the requirements for products and
services to be offered to customers. The organization shall conduct a review before committing to supply products and
services to a customer,
The HOD Mkt authorizes and maintains record of the contract review and amendments if any.
6. RECORDS:
SCHEDULE V/S PLANNING V/S PRODUCTION V/S SUPPLY
F-MKT-03 2 01-02-2018
RECORD
F-MKT-04 RM REQUIREMENT AS PER SCHEDULE QTY 2 01-02-2018
F-MKT-05 DISPATCH DETAIL FOR CUSTOMER 2 01-02-2018
EXT Doc DOL REPORT SUBMISSION (HONDA ) 2 01-02-2018
F-MKT-06 FG STOCK TO CUSTOMER (HONDA ) 2 01-02-2018
1. PURPOSE:
The purpose of this procedure is to define a system to determine all customer specifications and records requirements
related to new/ revised product approval.
2. SCOPE:
This procedure covers all new / revised products to be developed by the company. PPAP file for the existing products
may be reviewed if required. for reference at all plant site in the Company.
3. DEFINITION / ABBREVIATION:
PPAP: Production Part Approval Process
PPAP File: File containing all PPAP records, documents customer wise.
Warrant: Standard Document shows conformance to customer requirements
Appearance Approval Report: Required for Components having Aesthetic Importance ( Color, grain, Surface
requirements) as specified by Customer wize:-Painted Parts, Plated Parts etc.
Dimensional report: Detailed Inspection Report of Part referred to the part drawing
Test Reports : (Material, Test & Performance) as specified in design record. Material as per Specification of reference
( IS, HES, JIS or other applicable standard) in Drawing
CRITICAL CHARACTERSTICS: Those characteristics that can effect subsequent operations, product function or
customer satisfaction, May be classified as:- Safety, Fit/Function, Aesthetic/ Appearance, Performance etc.
These Characteristics are variously termed
as “KEY”, “SAFETY”, “SIGNIFICANT”, “CRITICAL” Special Attention at all levels is desired for such characteristics &
Adoption of POKA YOKE to avoid any type of failure.
4. RESPONSIBILITY:
It is the responsibility of in-charge NPD / Prod., / Q. A. for effective implementation of this Procedure.
5. PROCEDURES:
Identify the requirement of customer notification and PPAP submission in customer specific requirement document
if not specified by customer will maintain PPAP record as per Level 3.
Review the documents and records as per required level. Prepare product submission warrant and submit the copy
of documents. Maintain the documents and records in PPAP file.
Follow up with customer for PPAP approval, In case formal PPAP approval is not received from customers, but
relevant P.O. / schedule for supply of product shall be taken as interim approval of PPAP. Company shall try to obtain
final PPAP approval from customers till five lots have been supplied.
If the PPAP approval is not received from the customers even after five supplies, it is treated as approved and
reviews the same in case customer requires certain change in product, document or records, co-ordinate to carry
out the changes and repeat the procedure for re-submission of PPAP.
Submission Levels:-
Level - 1
Warrant Only
Level- 2
Warrant + Samples + Limited Supported Data
Level-3
Warrant + Samples + Complete Supported Data
Approved by :Director Reviewed by : Head Quality
Signature: Signature:
SWARAN ENTERPRISES Rev No 02
AUTOMOTIVE QUALITY MANAGEMENT SYSTEM Rev Date: 01.02.2018
PROCEDURE MANUAL Page No 27 of 60- 27
(AS PER IATF 16949:2016) - of 60
Level-4
Warrant + Complete Supporting Data
Level-5
Warrant+ samples +complete supporting data reviewed at supplier’s manufacturing location
Note: Level-3 is Default level
When required
Prior to first production shipment
New Product or Part
Correction of previous submission
Product modification
Optional constructional Material
New/ Modified tool used
Process Change
Re-Arrangement of existing Tools or equipment’s.
Change in source of material
Tooling remains inactive for over 12 months
Change in transportation method/type of packing
Requirements
Submission Warrant
Appearance Approval Report
Sample Parts
Customer & Supplier Design records(Drawings)
ECN(Not incorporated in drawing but in Part)
Dimensional Results
Checking Aids(Gauges, fix, template etc)
Material Test Results
Process Flow diagrams
PFMEA
Control Plan
Process Capability results
Measurement System Analysis(Gauge R & R)
Design Engineering Approval
6. RECORDS
1. PURPOSE:
To define the procedure for Advanced Product Quality Planning activities including various stages of development of
Product and any engineering changes,
Stages-Pre-launch, Production & Mass production to facilitate communication with all concerned within the
Organization, Supplier & Customer, for ensuring that all required steps are completed on time.
2. SCOPE:
This procedure is applicable to all products manufactured by the Organization.
for reference at all plant site in the Company.
3. DEFINITION / ABBREVIATION:
CFT - Cross Functional Team
PFD - Process Flow Diagram
PFMEA - Process Failure Mode and Effect Analysis
MSA - Measurement System Analysis
APQP - Advanced Product Quality Planning
PPAP - Production Part Approval Process
DSPS - Development Schedule for Product Sample / Pilot Lot
4. RESPONSIBILITY:
It is the responsibility of Q.A. Deptt. Head/Section Head concerned Development agency, CFT and concerned Production
Depts. of all sections for effective implementation of this Procedure.
5. PROCEDURES:
Phases of APQP
Phase I- Plan and Define Scope
Phase II- Product design and development
Phase III- Process design and development
Phase IV- Product and Process validation
Phase V- Feedback assessment and Corrective action
The Procedure is based on the guidelines provided in the APQP standard and which is considered as part of this
Procedure. The five phases of Quality Planning are considered as the basic for the process of Planning. The
Organization is falling under the category of `Manufacturing only' as per the Product Quality Responsibility Matrix of
APQP Reference standard and the relevant phases of Quality Planning are defined in the following paragraphs:-
The Sales Dept. shall arrange the tentative schedule for new sample development along with relevant
Drawings/Samples /Standards/other instructions if any from the customer to the designated NPD in-charge.
NPD shall check the contents mentioned on the Development schedule. If found incomplete, the (DSPS)shall be
returned back to Sales Dept. for providing latest information.
NPD ensure the safe and secure storage of sample received from customer for reference purpose in development
activity. All relevant documents for new product development are kept in separate respective APQP file customer
wise at concerned section location by NPD.
Approved by :Director Reviewed by : Head Quality
Signature: Signature:
SWARAN ENTERPRISES Rev No 02
AUTOMOTIVE QUALITY MANAGEMENT SYSTEM Rev Date: 01.02.2018
PROCEDURE MANUAL Page No 29 of 60- 29
(AS PER IATF 16949:2016) - of 60
That the part happens to be similar to what had been produced so if 2 week to 4 weeks Alternate Day Bi Weekly
far but there happens to be large scale difference in raw
material, Machining Methodology, In the structure or in the if 4 week to ………… Weekly Bi Weekly
function.
A component similar to the component produced so far but there
happens to be
That whenever there happens to be changed in production site.
That whenever the place/country of development happens to be
different from the place/country of production
Whenever the Environment (Containing contaminant like Metallic
Chips, Dust) or else the degree of Moisture, Temperature, Pressure
and the safety Contents.
B- That whenever there happens to be a minor deviation in the if 1 week to 2 weeks Daily Weekly
component produced so far (To implement only For Inspection of
initial supply product) if 2 week to 4 weeks Alternate Day Bi Weekly
C-That whenever there happens to be extremely minor changes in if 1 week to 2 weeks Alternate Day N.R.
details related to the components ,so much so that even the inspection
becomes non mandatory (it Becomes more of checks in regard to if 2 week to 4 weeks Alternate Day N.R.
monitoring of the point of variation in regard to 4M if 4 week to ………… Alternate Day N.R.
7. RECORDS
F-NPD-01 INPUT RELATED TO NPD 2 01-02-2018
F-NPD-02 APQP MATRIX 2 01-02-2018
F-NPD-03 APQP TIMING PLAN. 2 01-02-2018
F-NPD-04 NAME OF CFT MEMBERS 2 01-02-2018
F-NPD-05 CFT MEETING RECORD 2 01-02-2018
2. SCOPE:
This procedure applies to those Production Processes that directly affect special to finished prodcut despatched to
customer at all plant sites in the Company. This procedure directly concerns Production and Quality Assurance functions
at all section in the Organization.
3. DEFINITION / ABBREVIATION:
PPAP - Production Part Approval Process
SPC - Statistical Process Control
4. RESPONSIBILITY:
It is the responsibility of Q.A. Deptt. Head/Section Head concerned Development agency, CFT and concerned Production
Depts. of all sections for effective implementation of this Procedure.
5. PROCEDURE:
The customer determines the criteria for acceptable processes, Guidelines for acceptable performance and
capability indices are provided in PPAP Manual, Preliminary Process Performance Evaluation, and in IATF
16949:2016, Preliminary Process Capability Requirements. The Cpk and Ppk values provided in PPAP, i.e., they are
used as criteria for acceptance of processes only when the customer does not specify other, higher or lower values.
If the attained Ppk and/or Cpk values are lower than those specified by the customer, the Quality Assurance
Engineer initiates a study to identify the special causes of variation and, if necessary, the common causes of
variation; and co-ordinates the implementation of corrective actions to eliminate or reduce the causes.
5.5 PROCESS CHANGES:
When there is a change of a part number, engineering revision level, material source, manufacturing location, or
production process, a new preliminary process capability study may be required. In the event of any such change
the Q.A. Deptt. Informs Sales Deptt., customer is contacted and asked whether a new study should be conducted.
When a process is highly capable, the Quality Assurance may reduce the sampling frequency and/or change the
process monitoring method. Q.A. Deptt. to obtain customer approval through Sales Deptt. Wherever change in
process monitoring is required.
CONTINUAL IMPROVEMENT
Even when processes attain the required capability and/or performance, they may be further improved, especially
when reduction of variation within tolerance is desired by the customer. The decision whether satisfactorily
performing processes should be further improved is made on the basis of a cost-benefit analysis, i.e., comparison of
the cost and effort required to further improve the process, versus the benefit the improvement will bring to the
customer. Continual Improvements to be carried out as per Procedure.
Knowledge of Statistical Concept is given to all concerned as per procedure for Training.
RESPONSIBILITY:
It is the overall responsibility of Q.A. Head to ensure the effective implementation of this Procedure.
It is the responsibility of relevant Development agency to ensure effective implementation during Preliminary
Process Capability study.
It is the responsibility of concerned Production Head to ensure effective implementation for ongoing process
performance.
6. RECORDS
F-PROD-10 SPC STUDY PLAN 2 01-02-2018
F-PROD-11 SPC STUDY REPORT 2 01-02-2018
1. PURPOSE:
To ensure procedure for exercising special controls during Initial Supply Control / Initial product control Period of mass
production.
2. SCOPE:
This is applicable to new or changed product in entire organization & outsources processes required to meet the
customer as well as product specified requirements.
for reference at all plant site in the Company.
3. DEFINITION / ABBREVIATION:
CFT - Cross Functional Team
PFC - Process Flow Chart
PFMEA - Process Failure Mode and Effect Analysis
MSA - Measurement System Analysis
APQP - Advanced Product Quality Planning
PPAP - Production Part Approval Process
DSPS - Development Schedule for Product Sample / Pilot Lot
4. PROCEDURES:
The initial supply control is applicable where:-
A. Newly developed products
B. Changed Part
Any major change in the existing part
Material change
Dimension/specification change
Safety/performance/regulatory requirement
Process Change (Major change):-
Layout change/sequence change/location change/source change/inactive parts activated etc.
Minor Changes:-4 M Control
Definition of initial product : - Initial product is the first piece / part or lot or samples from the first lot produced
during production trial, mass production trial, after PPAP of a new part or a part involving changes (design change,
process change & 4M change point.
Initial part / product will be identified with (tag Details).
Duration of Initial Supply Control (after SOP at customer end) :-
The duration of initial supply control is listed as below
3 months for new products from start of Customer PPAP
3 months or 3000 parts
QA Head is responsible to announced start of Initial supply Control through CFT Meeting & shift morning meeting
and initial supply control sheet shall be display on display board.
Process Activity-Define the targets for initial supply
Special controls during Initial Supply/Initial product control:-
Increased Sample size during in-process inspection--- will be double e.gn = 10 Nos in place of n=5 Nos as compare to
regular check & record to be maintained during initial supply control.
Conduct capability evaluation as per plan For Significant/Critical Dimension.-Cp/Cpk value.
Problems observed during initial supply control/initial product control period such as in-house rejections,
customer returns are reported to engg. Personnel on daily basis & the analysis &countermeasures details are
recorded separately.
Process capability study are conducted Significant/Critical Dimension at any stage if the process show sign of
instability or show less capability , then corrective actions shall be taken to improve the Cpk value
All process under initial supply/initial product control to be identified by putting displays on each process for batch
production. For single pc flow process, the start & end station may be identified.
Production during initial supply/Initial product control period shall be carried out under guidance of H.O.D-
Engineering, Setup & in-process inspection shall be carried out by QA as per the inspection standard for initial
supply control. These controls should be decided on Pre-launch control plan during project. For special controls due
to major & minor change , specific work instructions with covering the special controls to be made & displayed.
Start & end date of initial supply control shall be displayed.
Provide clear marking & stratification for products which have been subjected to changes of design or process
change to avoid mixing of products manufactured before & after the changes.
Proper identification is placed on the initial supply products during the initial supply control period with the color
coded proper identification tags called as “ FPP tag “.
Termination condition of Initial supply control period:-
Target
Internal Rejection PPM target
Incoming Rejection PPM target
Cpk value found satisfactory
All problems occur before SOP are resolved
Countermeasures taken against problems observed during initial supply control period itself are effective.
Any other
At the end of period if the above conditions are met, then the termination of ISC is announced by QA Head. If the
above condition is not met than ISC period will be extend for next one month.
6. RECORDS
1. PURPOSE:
To define a system for supplier selection, purchasing and periodic evaluation.
2. SCOPE:
This covers approval of supplier for purchasing of various products i.e. raw material, consumables, packing material, job
work, tool, dies, jigs, fixtures and services etc.
3. DEFINITION
Supplier: Who can develop and/or supply product conforming to specified requirements by undergoing a contract.
Approved supplier list: List of supplier who has been apprised and approved.
Supplier Selection: Selected supplier as per defined criteria of selection.
Approved by :Director Reviewed by : Head Quality
Signature: Signature:
SWARAN ENTERPRISES Rev No 02
AUTOMOTIVE QUALITY MANAGEMENT SYSTEM Rev Date: 01.02.2018
PROCEDURE MANUAL Page No 36 of 60- 36
(AS PER IATF 16949:2016) - of 60
4. RESPONSIBILITY: Overall responsibility lies with HOD Purchase. Specific responsibilities are listed against each
activity as below:
5. Procedure
Purchasing:
HOD (QA) defines the “Purchase Specifications”, applicable as a basis of the requirement of product. The HOD (QA)
approves by director and issues the Purchase specifications to purchase department.
Prepare Purchase Order mentioning relevant technical details. ( For Job work we can issue annual PO )
Prepare Purchase Order for approved supplier and ensure that PO contains the following:
Item name/Part No.
Purchase specification/ Drawing no if required
Quantity
Commercial Terms
Document required along with supplies
Packaging details
Mode of transport
Reference of Po on invoice.
Raw material test certificate.
Freight
Any other special conditions
Delivery schedule
Enter the details of PO in supplier evaluation record
Review the PO for approval
Review and approve the PO before release
Follow up for supplies for timely delivery
Selection of suppliers:
All suppliers till 1st Sep 2017 will be treated as approved suppliers.
Suppliers are assessed and approved, if found suitable, on the basis of any one or more of the following criteria: as
per selection criteria checklist that checklist carries below mentioned points.
Market reputation.
Location
Past performance of their supplied material / components.
Potential capability to supply material as per the requirements consistently.
Quality Management system Implementation status
Quality policy
Organization structure
Plant lay out
Min. Mat. Handling
Buffer inventory
Is there system for tooling identification and maintenance?
Tin. No.
Cost
Delivery time
Transportation
Sample lot
Are work instructions available for all manufacturing operation?
Is material handling proper?
Approved by :Director Reviewed by : Head Quality
Signature: Signature:
SWARAN ENTERPRISES Rev No 02
AUTOMOTIVE QUALITY MANAGEMENT SYSTEM Rev Date: 01.02.2018
PROCEDURE MANUAL Page No 37 of 60- 37
(AS PER IATF 16949:2016) - of 60
NOTE: This decision to issue further order is to be based on performance rating of the supplier.
6. RECORDS
F-PUR-01 SUPPLIER APPROVEL RECORD 2 01-02-2018
F-PUR-02 APPROVED SUPPLIER LIST 2 01-02-2018
F-PUR-03 RM REQUIREMENT 2 01-02-2018
F-PUR-04 PURCHASE ORDER. 2 01-02-2018
F-PUR-05 SUPPLIER SCHDULE V/S SUPPLY 2 01-02-2018
F-PUR-06 SUPPLIER PPM 2 01-02-2018
PREMIUM FREIGHT RECORD ( SUPPLIER /
F-PUR-07 2 01-02-2018
CUSTOMER)
F-PUR-08 SUPPLIER RATING RECORDS 2 01-02-2018
F-PUR-09 SUPPLIER AUDIT PLAN. 2 01-02-2018
F-PUR-10 SUPPLIER AUDIT CHECK SHEET. 2 01-02-2018
2. SCOPE
Applicable to order executed in production.
3. DEFINITION
HOD - HEAD PRODUCTION
4. RESPONSIBILITIES
HOD (Prod.) is overall responsible for control of the production and planning function.
Store In-charge is responsible for material planning based on schedule requirements.
HOD (Prod.) is responsible for Production Planning based on schedule requirement.
5.0 PROCEDURE
Receive delivery schedule from customer through Marketing Deptt.
Material request send to Stores for raw material
Perform material planning based on stock position and requirements, send purchase requisition for raw material to
Purchase Deptt after approval from Director
Maintain necessary follow up to avoid any hold up due to material shortage
Prepare monthly production planning schedule .Then prepare on weekly basis, based on monthly schedule received
from the customer
Receive daily production report.
Examine the production planning schedule daily and follow up with respective sections in case of urgency
Receive revised schedule, if any from customer through Mktg. Deptt
After completion process, receive production report
Keep follow up for the hold schedule
Keep follow up with dispatch section for processing and dispatch of balance product
6. RECORDS
2. SCOPE
Applicable all materials and products.
3. DEFINITION: Nil
4. RESPONSIBILITY
HOD QA is overall responsible for inspection & testing of Raw Materials, in-process and products.
Responsible for calibration of measuring instruments related to product and process measurement.
Responsible for status identification ( tagging )
Responsible for maintain record of inspection
Production Supervisors are responsible for checking of in-process material and its release for further processing.
Quality inspector will cross check the material checked by production.
4. PROCEDURE
Receiving Inspection
Receive Intimation slip from Stores intimating arrival of material. by the time material is kept in under inspection
area.
If the material is accompanied by Test Report all required documents than quality perform the incoming inspection.
Draw sample from the received material based on control plan.
Check/test the samples for the requirements and maintain records in dimensional inspection report/Lab report.
Compare the results with the values given in relevant Inspection Standards.
If material is found as per the specifications send Lab report to Stores
If material is ok than material is transfer to the RM store with ok tag and report.
Such material can be released for processing.
In case the material is found rejected, mention the reason of rejection on tag and incoming inspection report and
transfer the material in red bin area.
Also intimate to supplier through purchase department for the non-conformance and ask for Corrective action.
FPA & In-Process Inspection
Draw sample s as per sampling plan for in-process inspection as material inspected by production operator.
Prepare the line inspection report.
Maintain records and compare the results with Inspection Std.
Maintain inspection report indicating conformance/non-conformance of the product.
Release conforming material to next user section with tag.
Check the components at each stage of operation as per the control plan /operational standards.
Maintain records.
Carryout patrol inspection at each stage of processing as per control plan.
Maintain record of in-process inspection.
In case the material is not meeting the specified requirements, intimate the same to Asst. HOD (Prod) and record the
same in inspection report
6. RECORDS
F-QA-02 MASTER LIST OF CONTROL PLAN. 01-02-2018
For any damage observed before using, send the Tool to the Tool Room with problem mentioned on the Tool History
Card for rectification.
For any problem during production send the Tool along with last sample piece and tool History Card (Problem
mentioned) to Tool Room for rectification.
Check the identified problem. Record rectification done in History Card and issue the Tool and History Card to
Production.
Maintain machine check sheet and time sheet.
Keep all Tools/ Die properly.
Check the dies for the defect, if any, for the requirements as per the relevant operational standards list at the time of
use. Record in the Tool History Card.
If any defects are observed, send the Tool and Tool History Card to Tool Room for rectification.
Apply grease/lubricating oil as applicable to avoid rusting during storage.
Review Tool/Die History Card each time a Tool is scrapped and new Tool is planned for incorporating.
modifications/changes
New tools/ Dies shall be planned when tool/ die life is left 25% as tool/Die life defined in tool history card.
If tools/ Dies are provided by customer than same shall be informed to customer, if tool/ die is responsibility of SE
than intimated to tool room for the same.
The in-charge of tool room is plan and manufacture tools as per process flow diagram.
Note: if customer / SE seems that die / Tools are fit for use after defined life than life of tools die shall be extended.
Ensure all the toolings are kept as specified location for easy retrieval.
Perishable Tools
Assess the list of perishable Tools used in the company and determine frequency of change. Record in the Tool
History Card.
Plan the manufacturing of new Tools depending upon the time to be taken for making new Tools.
Control of Consumables
Depending upon the consumption prepare tentative requirement of spares and consumables for the Tools.
Decide minimum stock level of all spares and consumables.
Indent and follow up with Stores for timely availability of all the items
6. RECORDS
F-PROD-13 LIST OF TOOLS AND DIES 01-02-2018
After receipt inspection if the material found OK, the “Under Inspection” tag is replaced by “OK” tag identifying the
material.
Keep the approved material at designated locations and update in Stock Register
Keep the maintenance spares at identified racks duly numbered and maintain records in Stock Register
Store in-charge tag the material with the following details:
a) Material Name
b) Party Name
c) Challan No./Date
d) Quantity received
e) Heat no.
Store in charge issue the material with job card duly mention heat no, material issued qty, product qty to be
produced.
PRODUCTION DEPARTMENT.
Receive raw material from Stores with in-process identification tag having details of components name , Heat No,
Qty etc. For purpose of Traceability.
Production is responsible to carry this heat no on daily production reports and tag of next operation.
Quality will also mention this heat no on in-process and final inspection report.
PACKING
Receive material from Production Deptt. Along with Heat No and Production Slip.
Affix Material identification ok tag .with following information
Invoice no.
Part number
Date
Heat No
Qty
Enter this detail in final inspection report / PDI and invoice also.
6. RECORDS
1 PURPOSE:
To establish and maintain system for handling, storage, packaging, preservation and delivery of products in order to
avoid deterioration of quality.
2. SCOPE
Applicable to all products from raw materials stage to dispatch of finished products.
3. DEFINITION
U/I (Under Inspection)
4. RESPONSIBILITIES
Respective Sectional Heads are responsible for safe handling of products in their area of activity.
HOD Dispatch is responsible for packing and delivery of finished products and monitoring the 100% on time delivery
performance.
5. PROCEDURE
Handling: Product handling shall be done at various stages from receipt till dispatch as per handling work
instruction. Due consideration shall be given to the specific instruction given on the packaging by the SUPPLIER.
STORAGE
Keep O.K material at proper location manually, identified with O.K tag./ lot no and heat no or as applicable
identification no.
Issue material for production.
After processing, transfer O.K.
Material to next operation. Keep rejected material in red bin, hold and U/I material in bins with yellow tag.
During finishing, visual inspection, final inspection for O.K tags, red tags for rejected and yellow tags for hold
material.
After final inspection, pack components in specified quantity in in standard size cardboard boxes.
Transfer packed material to Finished goods store or dispatch area , & then dispatch by using trolleys for safe
movement of the material.
Load the boxes manually in the truck
PACKAGING
Receive job card and Production slip along with material.
Carryout 100% visual inspection for defects, if any
Segregate the conforming and non- conforming material, keep conforming material in blue bin and provide “Hold”
tag to non-conforming material kept in the yellow bin.
Reject the material, if found not usable and keep in “Reject” red bin.
Offer the material to Q.A Deptt for final inspection
Provide “O.K.” tag for conforming material and “Hold” tag for non- conforming material.
Take decision on “Hold” material as per procedure for “control of non- confirming products”.
Keep records of conforming and non- conforming material in register.
For products, print batch No. & Part No. on individual packets.
Pack the material as per guidelines given in packing list.
The packing performed as required by customer.
Every boxes ready for dispatches are marked by customer Name/ part name/ part number and quantity
Shift the material to dispatch area.
Maintain records of material transferred to dispatch.
PRESERVATION
Appropriate action is applied to protect product during the realization process.
DESPATCH
Receive dispatch schedule from Marketing Department.
Provide packing tag indicating following identification with each box as per the specified requirements of packing by
the customer
a) Date of dispatch
b) Customer Name
c) Part No.
d) Total quantity
e) Challan No. etc
Inform the dispatches being made to Director.
Prepare documents as per legal and other requirements and keep records.
Prepare Invoices and Challan for respective dispatches.
Approved by :Director Reviewed by : Head Quality
Signature: Signature:
SWARAN ENTERPRISES Rev No 02
AUTOMOTIVE QUALITY MANAGEMENT SYSTEM Rev Date: 01.02.2018
PROCEDURE MANUAL Page No 47 of 60- 47
(AS PER IATF 16949:2016) - of 60
Load the material in vehicle and ensure that stacking of boxes do not exceed as decided. In monsoon season, cover
the body with tarpaulin for open trucks.
Handover Excise Gate Pass, Invoice and Challan to driver of the vehicle.
Advance shipment notification systems to customers are followed if required by the customer.
On time delivery performance monitoring.
Based on customers schedule make a statement of actual dispatch on monthly basis.
Analyze the reason for less than 100% on time delivery
Take necessary corrective action if delivery is not 100% on time.
Records of premium fright for outgoing material shall be maintained
6. RECORDS
1. PURPOSE: To ensure flow of internal and External Product, Process and document changes and to ensure proper
implementation for the same
3. DEFINITION / ABBREVIATION:
CFT- Cross functional Team
PPAP- Production Part approval process
4. RESPONSIBILITY:
It is the responsibility of Q.A. Deptt. Head/Section Head concerned Development agency, CFT and concerned Production
Depts. of all sections for effective implementation of this Procedure.
5. PROCEDURES:
Checking of parts within a specific time (minimum 1 hour or whatever is required) without any unplanned change.
If any changes done in man, machine, material or method related to process happens, the information shall be
recorded immediately in change point monitoring board.
Change should be done after On – Job training, Inspection Record should be maintained, Production record, OK &
Reject data of every hour. If there is no change, then ‘No Change’ to be written.
Criteria for 4M change is according to WI
ECN change – ECN coordinator
All process parameter change – Quality HOD
Fixture/jigs/gauges – Quality HOD
Insp. Equipment & procedure – Quality HOD
Manufacturing process – Production Head
It is to keep the inspector on line informed of any kind of changes in man (inspection record in production record &
OK & reject data), material, method & machine which happens in his/her area
It should cover the following:
1. Shop name
2. Line No. / Area
3. Date of occurrence of change
4. Machine no. where change has occur
5. Details of change
6. Special checkpoints for inspector
7. Validity of the change
8. Supervisor signature
9. Inspector signature
10. The change detail of man, machine, material & method to be noted down separately on different cards with same
format.
The color of the cards should be as follows :
1. Man – Yellow
2. Material – Light Blue
3. Machine – Green
4. Method - Magenta
Frequency of special checkpoints to be as follows with responsibility:
Line inspector will check the part dimensionally once in 3 hours.
Customer to be informed immediately after the change has occurred through mail only for
Material, machine & method. Supporting documents for each change to be shared with customer.
4M change board for internal communication to be updated immediately for internal personnel.
9 Machine Major refurbishment (parts changed Machine No Yes Inspection Report Quality
which may affect quality parameters)
11 Job Tool Change from Plant to Plant All Applicable Yes Yes PPAP Documents Customer
12 Job Tool Change from Plant to Supplier All Applicable Yes Yes PPAP Documents Customer
13 Job Tool Change from Supplier to Supplier All Applicable Yes Yes PPAP Documents Customer
14 Job Tool Change from Supplier to Plant All Applicable Yes Yes PPAP Documents Customer
15 Tool Recovered Inactive >2 Years Machine No Yes Inspection Report Customer
16 Production from new Duplicate Mold Machine Yes Yes PPAP Documents Customer
6. RECORDS
1. PURPOSE:
To Establish a Process for rework and handling of rework parts.
2. SCOPE:
Applicable to all Production lines
For reference at all plant site in the Company.
3. DEFINITION / ABBREVIATION:
CFT - Cross Functional Team
PFC - Process Flow Chart
PFMEA - Process Failure Mode and Effect Analysis
Nonconformance: A deficiency in characteristic, documentation or procedure which renders the quality of an item
unacceptable or indeterminate. Examples of non conformances include: out of specification condition, test failures,
incorrect or inadequate documentation, or deviation from prescribed processing, inspection or test procedures.
Rework – Bringing a non-conforming part back into conformance by simply reprocessing a prior sequence.
Repair – Bringing a non-conforming part back into conformance using methods outside the original process.
Scrap Product: Product cannot be reworked, and must be isolated & scrapped.
4. PROCEDURES:
Red bin analysis shall be conducted every day with head production, head quality, purchase in-charge, tool room in-
charge and others as required.
Three type of rejection are discussed in red bin meeting ( supplier rejection , customer rejection and in-house rejection)
In the event a suspected nonconforming condition relating to product is detected same shall be presented in red bin
analysis meeting.
Red bin team members with authority from key functional areas (e.g. quality, engineering, operations), and temporary
members. which have knowledge of the problem and/or the resolution.
Anyone who detects a suspected nonconforming condition shall be responsible for properly identifying that condition by
initiating Nonconformance Case.
When product is suspected to be nonconforming, it must be conspicuously identified and controlled to prevent its
inadvertent use. The suspect lot shall not be moved/relocated until a disposition is made.
In case supplier rejection-- head purchase will call to supplier for meeting and discuss with supplier for reduce the
same in the presence of quality head
And jointly prepare the MOM and monitor the same for reoccurrence.
In case of customer rejection-- Quality in-charge will answer that why this rejected material dispatched to customer
and take action by improving detection method than production will provide solution ( why its produced and it will not
produce in future by taking action on occurrence method ) quality head will fill 8 D format.
In case of in-house rejection-- Production will provide solution (why it’s produced and it will not produce in future)
quality head will fill 8 D format for the same.
After discussion jointly decided for material to be reworked or not.
Rework
Rework able material transfer in yellow bins and non-rework able material will keep in red bin ( in lock & key)
The disposition of “rework”, shall be accompanied by rework instructions, completed by the Red bin team. Reworked
product shall be reinspected in accordance with the standard inspection procedures
The Red bin team is responsible for appropriately distributing case findings, initiating appropriate action and retaining
nonconformance case records.
Customer Support shall be involved with nonconformance cases involving delivered products. Corrective action requires
notification of customer and possible recall or other actions.
If the disposition of nonconforming product renders it different from customer specification, customer notification may
be required. Customer Support shall notify the appropriate customer contact
Same shall be recorded in rework and scrap registers.
After perform rework process, 100% inspection is performed and report is also prepared,
Record of production of reworked items are carry Heat no / lt no, date, reworked performed by, Qty etc.
Inspection report of reworked material is identified with deferent document id.
Instruction related to rework and inspection of reworked material is prominently displayed.
All scraped material shall be discarded first week of every month and also calculate cost as per COPQ calculation format.
If any nonconforming product can be supplied (there is no impact on functionality and safety). Same shall be intimate to
customer before supply, if he allow than will supply the same (supply under deviation).
Repair
Non Rework able material is review for repair, if possible than same shall be repaired
Repairing shall be accompanied by repair instructions, completed by the Red bin team. repaired product shall be
reinspected in accordance with the standard inspection procedures
Also intimate to Customer for the repairing done.
Same shall be recorded in repair registers.
Record of production and inspection of repaired items are carry Heat no / lt no, date, repair performed by, Qt
Records
F-PROD-06 REWORK REGISTER 2 01-02-2018
1. PURPOSE
To determine whether quality activities and related results comply with planned arrangements and also to determine
effectiveness of the quality management system.
2. SCOPE
It covers complete Quality management system audit, product audit and manufacturing process audit.
4. RESPONSIBILITIES
Management Representative is to ensure planning scheduling, co-ordination and maintenance of records of Internal
Quality Audits.
5. PROCEDURE
Auditors shall not audit their own work. Internal Audit is conducted by qualified auditors (minimum IATF 16949: 2016
internal auditor).
Internal audit is planned and carried out as given below
a) System Audit -once in a six month.
b) Manufacturing process Audit -once in a six month.
c) Product Audit –at least cover all product once in a year
d) Second Party Audit- once in a year
System Audit
In system audit cover all sections of IATF 16949–2016 Clause, Sub Clause & Sub-Sub Clause are covered. However, the
frequency may be changed depending on the number of non-conformities encountered in that section. Refer Internal
Audit Check sheet
Product Audit
In product audit verified all critical dimension, packaging and labeling.
The organization shall audit products using customer-specific required approaches at appropriate stages of production
and delivery to verify conformity to specified requirements. Where not defined by the customer, the organization shall
define the approach to be used.
In layout inspection verified all dimensions as per drawings, all parameters of visual inspection and material testing is
also carried out
Records of previous audit/non-conformity reports and corrective action reports are provided by M.R. to the auditors for
ready reference. Refer Internal Audit Reports.
During the audit, any non-conformities or discrepancies from the laid down procedures of IATF 16949:2016 are noted
on the Non-Conformity Report and acknowledged by the auditee.
After the audit, the N.C.R.s. is submitted to the M.R. who sends this N.C.R.s. to the respective departmental heads for
initiating corrective action.
The department representative / auditor, in whose audit non-conformity has been observed, decides the corrective &
preventive actions, plans the target dates, records them on N.C.R. and initiates corrective action. On completion of the
corrective action, he sends the information to MR for initiating the closing process. M.R. along with a qualified auditor to
verify the corrective action and close the N.C.R. A copy of N.C.R is kept with M.R. for his record and effectiveness of audit
discussed in Management Review Meetings.
The MR prepares an Audit Report for reporting to Organization Head after an audit. All audit reports are complied by
M.R. and submitted for Management Review.
6. RECORDS
1. PURPOSE
To establish and maintain a system for reviewing the effectiveness of Quality management System at regular intervals to
ensure its continuing suitability, adequacy and effectiveness.
2. SCOPE
Its cover minimum all agenda points as required by IATF 16949:2016.
3. DEFINITION
MRM-Management Review Meeting
4. RESPONSIBILITY
5. PROCEDURE
The Management Review meeting shall be held once in a six month
Management Representative shall organize the respective Management Review Meetings and discussions take place
according to Agenda.
The Minutes of respective Management Review Meetings shall be prepared by Management Representative and after
approval by respective Heads. Shall be circulated to all participants.
Management Representative shall maintain the records pertaining to Management Review Meetings for a period of 3
years.
The action requirements arising out of meetings shall be forwarded to concerned HOD and monitored by Management
Representative/Director.MR is responsible for conduct of Management Review meeting.
The composition of Management Review Committee (Plant) shall be:
Director : Head
HOD (Mkt.) : Member
HOD Maintenance : Member
Pur/Q.A/Prod/Tool Room : Member
All participants should be present in the meeting with their data as required by agenda points for discussion.
The Agenda for Management Review Committee (Plant) meeting shall include the following:
1. Pending issues from previous MRM (if any)
2. Cost of poor quality (cost of internal and external nonconformance);
3. Measures of process effectiveness;
4. Measures of process efficiency;
5. Product conformance;
6. Assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new
product.
7. Customer satisfaction
8. Review of performance against maintenance objectives;
9. Warranty performance (where applicable);
10. Review of customer scorecards (where applicable);
11. Identification of potential field failures identified through risk analysis (such as FMEA);
12. Actual field failures and their impact on safety or the environment .
Agenda of Management Review Meeting based on IATF 16949: 2016 would be as per checklist.
Meeting is chaired by Directors.
MR will maintain records of minutes as discussed on every point.
MR will record action decided, responsibility, target date for review.
Also record the any resources required for the same and provided as decided in the meeting.
Record of meeting along with evidence shall be maintained.
6. RECORDS
1. PURPOSE
To prevent unintended use of Non-conforming products.
2. SCOPE
Control of all Non-conforming products at all stages.
4. RESPONSIBILITY
MR & All Section Representative
5. PROCEDURE
Section Representative identifies the Non-conforming products during various stages like incoming, in process, final
inspection and returned by customers by tags and inspection reports.
All customers returned product are re inspect in SE as per final inspection criteria and record maintained. After
segregation ok material are moved in FG and rejected material is shift to rejection area affix red tag mentioned with
complete detail as per format of red tag.
Records of non-confirming Product & Process are analyzed on immediate basis.
Non-conforming Product is identified by Red Color tag / marking/ and kept in red bin are as provided to keep for Non-
conforming products.
Quality Control Representative /Relevant authorities evaluates the nature of Non-conformities and decides the
disposition action of Non-conforming products which may be
Re-worked to meet the specified requirements.
Accepted with or without repair by concession (under deviation).
Use for alternative applications. or scrapped ( all scarped material is kept in red bin in lock and key and discard the same
at defined frequency ( once in a month ).
Re-worked product is re-inspected in accordance with quality plan (As per procedure of rework) and if confirm to the
specification than send to the point of use if accepted under deviation by relevant authority than all records and details
are maintained in Concession/ Deviation Note.
Records maintain as per activity performed reworked or scrapped
CORRECTIVE ACTION
Reviewing Non conformities included customer complaints, Feedbacks, determine causes of Non conformities,
evaluating the need for action to ensure that non conformities do not reoccur, determining & implementing action
needed. Data of In house rejection/ Problems/ Supplier Problem/ Customer Returned is maintained and Recorded.
Action is taken as soon as possible, to resolve the complaints to the satisfaction of the Internal/ external customer and to
prevent their reoccurrence.
Causes of non-conformities product, process and quality system are investigated and result of the investigation is
recorded in Counter Measure Report.
Corrective Action is taken to eliminate the root cause and prevent reoccurrence of non-conformities in consultation with
related Dept. Representative.
Compile the monthly records of customer feedback/ complaints and product non-conformities to determine the
corrective action to minimize them.
Recognize accomplishments & team process
Describe the problem in measurable terms. Specify the internal or external customer problem by describing it in specific
terms (Object + concern + quantification)
Take containment actions (Common containment actions include:100% sorting of components “ in-house and
customer end”, Rework “ in-house and customer end” )
Identified root cause
Identify potential causes which could explain why the problem occurred.
Test each potential cause against the problem description and data.
Identify alternative corrective actions to eliminate root cause.
Five times, why-why analysis in order to get to the root cause of the problem?
There can be more than one cause to a problem as well.
This root cause analysis is shall be done by a team with knowledge the problem process or item.
After root causes and possible corrective actions have been identified, select the corrective actions that will
permanently correct the problem.
Implement best corrective action as selected & verified.
Monitor after implementation to ensure the corrections are permanent.
If problem is closed than change in all related documents and close the Nonconformance.
If possible horizontal deployed the same.
6. RECORDS
2. SCOPE:
This procedure is applicable to all complaints and negative feedback received from customer.
4. RESPONSIBILITY:
Head Marketing is responsible for customer interface (receiving and communicate closers), for the rest QA head is
responsible for implementation of this procedure.
5. PROCEDURE:
All complaint received in the company shall be reviewed by head marketing.
6. RECORDS