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Self Assessment Checklist (ISO/TS16949 Requirements)


S.
Clause
No.

4.2.3

Standard
Requirement

What to look for

Control of Douments

1. All documents to be there in Prism with


approval
2. List of Records and Documents in place
and maintained
3. Approved Documents in use.
4. Control Copy seal in all documents.
5. Currnt Review in usage

Control of Records

1. Identification of Records
2. Current revision in usage
3. Retention period (3 years)
4. Storage & Retrieval of Records
5. Document Issue Control register
6. Records retention sholud be in line with
statutory requirements

Quality Policy

1. Display of Integrated Policy at site


2. Integrated policy communicated to all

4.2.4

5.3

5.4.1

Quality Objectives

All the KPIs sholud be in GMR, when not


reaching the goal FCA to be prepared

5.5.1

Responsibility &
Authority

1. Updated document in usage


2. All the roles are identified and
corresponding responsibilities are
mentioned

1. Personnel responsible for non


conformity of the product in each area is
5.5.1.1 Responsibility for Quality identified or not
2. The same sholud be included in Roles &
Responsibilities

Department:
Status with evidence

S.
Clause
No.
8

10

5.5.3

6.2.2

Standard
Requirement

What to look for

Internal Communication

Communication meeting agenda and


minutes to be avaliable in all the areas.

Competence, training &


Awareness

1. Skill Matrix
2. Training Matrix
3. Critical training identification
4. Training Plan
5. Training Records
6. Training Effectiveness
7. Actions on Training Effectiveness
All the above for bot GSI & Contract
employees to be avaliable

6.3.1
Updated Contingency plan to be made
ready
1. 5S initiatives
2. Action Plan
3. Audit results

11

6.3.2

Contingency plan

14

6.4.2

Cleanliness of Premises

17

7.1.1

Inclusion of customer
requirements and
Must be components of the quality plan
technical specs in quality
planning

18

7.1.2

Acceptance criteria,
especially for attribute
data sampling

Acceptance criteria defined?


Approved by customer, as reqd.
Zero-accept for attribute plans

7.1.3

Confidentiality of
customer contracted
products and projects
under development

NDA agreement with customer


Confidentiality agrement with customer's

19

Status with evidence

S.
Clause
No.

Change Control

7.2.1.1

Customer designated
special characteristics

Identification of special in control plan,


FMEA

7.3.1.1

Multidisciplinary
Approach

Review of PFMEA & Control Plan by CFT


Minute of Meeting of review

7.1.4

21

16

37

20

What to look for


Procedure for Change Control
Assessment of impact
Verification & validation method
Review w/ customer as rqrd.
Applicable to manufacturing changes

15

18

Standard
Requirement

7.3.2.3 Special Characteristics

Identification of Special characteristics in


Control Plan
Are all special characteristics included in
control plan?
Complies with customer symbol
Identify process control documents
(drawings, FMEA, operator instructions)
with SCs

Process to assure the


7.4.3.1 quality of purchased
product

Defined methods for incoming product


test or verification, e.g.
Receipt & evaluation of supplier statistical
data
Receiving inspect or test
Assessments of supplier site
Part evaluation by laboratory
Other agreed method

7.5.1

Contol of Production &


Service provision

Availability of Work instructions


Implementation- following of SOP's

Status with evidence

S.
Clause
No.

Standard
Requirement

What to look for

Development of control
plans for product
supplied, including
7.5.1.1
customer required
information and
review/update

Are control plans developed for


System and sub-system level
Component or material level
Pre-launch and production
Considering FMEA
Do control plans address
Manufacturing process controls
Method for monitor of special ch.
Customer required information
Reaction plan
Evidence of update if significant product
or process change

40

7.5.1.2 Work instructions

Documented
Accessible at the work station
Derived from sources such as control plan,
quality plan

41

Check set-up verifications at


Initial run of job
Verification of job setMaterial changeover
7.5.1.3 ups, according to set-up Job change
work instructions
Are work instructions available?
Are statistical methods of verification
used?

42

Identification of key process equipment


Resources provided
Preventive maintenance plan
Preventive maintenance PM plan includes:
7.5.1.4 & Predective
Planned activities
Maintenance
Packaging and preservation of equipment,
tooling, gauging
Availability of replacement parts
Documented maintenance objectives

39

Status with evidence

S.
Clause
No.

21

22

47

23

Standard
Requirement

What to look for

Tooling Management
Resources for tool and gauge design,
fabrication, verification
Production tooling;
Tooling management program includes:
7.5.1.5 including monitor of any Maintenance and repair
outsourced work
Set-up, storage, recovery
Tool change, for perishable tools
Tool modification documentation
Tool identification & status

7.5.2

Validation of process

Validation of processes for


1. Change in parameters mentioned in
control plan
2. New process or product

Requirements of 7.5.2
Verify scope of application
must apply to all
7.5.2.1
Verify actual examples from products
processes for production
offered/jobs running
& service provision
7.5.3

Identification &
Traceability

Identification & Traceability of product &


all areas

48

Requirements for
Defined method
identification of product
7.5.3.1
Suitable means
must apply through
Traceability identification, as rqrd
entire product realization

24

First in & First out.


What is inventory management system?
Storage & inventory (for
7.5.5.1
How is stock rotation ensured?
product as well as
How is obsolete product controlled?
Is condition of stock assessed at intervals?

Status with evidence

S.
Clause
No.

25

7.6

Standard
Requirement

Control of Monitoring &


Measuring Equipment

What to look for


Calibration & Records
1. For all the instruments that are there in
Control Plan &
2. Instruments that effect product quality

Must include gauges, measuring and test


equipment including employee-owned
and customer- owned gauges
Records must include following:
Equipment identification
Specific requirements for
Revisions after engineering chg
records of calibration
Out-of-spec readings as received
activity
Assessment of impact
Statement of conformance to spec after
calibration
Notification to customer if suspect product
shipped

52

7.6.2

26

8.1

Measurement, analysis &


actions on Quality objectives deviation
Improvement

29

8.3

Control of
Nonconforming product

Actions to eliminate the detected non


conformity
Authorize its use
Records for non conformity & its actions

68

8.3.1

Supplemental controls
over nonconforming
product

How is suspect product treated?


How is unidentified product treated?

31

8.5.1

Continual Improvement

Continual improvement projects and their


status

Status with evidence

S.
Clause
No.

33

8.5.2

Standard
Requirement

Corrective Action

What to look for


Determining causes of no conformances,
actions, evaluating the actions, records &
reviewing the effectiveness of the action
taken. Implementation to similar
processes also.
Examples of error-proofing applications
Related to corrective actions

76

8.5.2.2 Use of error-proofing

77

Examples of application of corrective


8.5.2.3 Corrective action impact action to other similar products/processes
Method of control implemented

34

8.5.3

Preventive Action

Prevention of non conformance, prventive


actions taken, records & effectiveness

Status with evidence

Date:
Action Plan, if not OK

Who

When

Action Plan, if not OK

Who

When

Action Plan, if not OK

Who

When

Action Plan, if not OK

Who

When

Action Plan, if not OK

Who

When

Action Plan, if not OK

Who

When

Action Plan, if not OK

Who

When

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