Interpretation on Verification of Job set-ups, Layout Inspection,

Manufacturing Process Audit and Product Audit

ISO/TS 16949:2009(E) QMS Standard requirement

7.5.1.3 Verification of job set-ups
J ob set-ups shall be verified whenever performed, such as an initial run of a job, material
changeover or job change.
Work instructions shall be available for set-up personnel. The organization shall use
statistical methods of verification, where applicable.
NOTE Last-off-part comparisons are recommended.

INTERPRETATION:

Whenever any new job is set, the process characteristics and the product characteristics has to
be verified in view of meeting customer requirements. It has to be ensured that the output of
such job setup satisfy the specified requirements relevant to the stage or the process step.

The Idea is effective control of the process. Hence whenever there is a break in the process,
the verification shall be done to ensure that the process assumptions are still valid. Thus
whenever the process is stopped for any purposes like Material change over or change of job
etc.. this verification shall be done to satisfy that the basis of assumption is valid.

The data may be recorded in the form of First Off and Last Off inspection report. Every time
when the data are recorded, the latest data may be compared with the previously recorded
data to ensure the consistency. Taking this into confidence approval may be given for the J ob
to continue.
With the available set of data appropriate statistical techniques may be used to assess the
performance of the process.


ISO/TS 16949:2009(E) QMS Standard requirement

8.2.4.1 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.

INTERPRETATION:

As per the customer requirements, to verify all the drawing specification given are correct on
individual basis. To verify the product with respect to each and every print provided in the
Customer drawing, Specification or any other customer specified performance standard or
any other customer specified engineering material.
This layout inspection has to be conducted periodically especially customer specified
frequency if any.




ISO/TS 16949:2009(E) QMS Standard requirement

8.2.2.2 Manufacturing process audit
The organization shall audit each manufacturing process to determine its effectiveness.

INTERPRETATION:

Actually a Process is set based on certain assumptions to get a product as an output with
specified characteristics. This means we plan to get a product with specified characteristics
by means of a Process.
By doing an audit, it need to be ensured whether the planned output is achieved. This is
nothing but the determination of the effectiveness of the planned process (Achieved / Plan =
Effectiveness).
This audit has to be conducted periodically especially customer specified frequency if any.

Eg: Verify the Set Process Parameters of a Process
Verify the resultant output (Product) of that Process with reference to the specified
characteristics.
Correlate the set process parameters verses the resultant output characteristics (Product
characteristics) and determine the effectiveness.

ISO/TS 16949:2009(E) QMS Standard requirement

8.2.2.3 Product audit
The organization shall audit products at appropriate stages of production and delivery to
verify conformity to all specified requirements, such as product dimensions, functionality,
packaging and labeling, at a defined frequency.

INTERPRETATION:

With reference to the Customer Specific requirements, at each stages of production of a
product, it has to be verified whether all the Customer Specific requirements were complied
or taken care.
This audit has to be conducted periodically especially customer specified frequency if any.

Eg: Incoming Inspection : Are the raw material purchased from Customer Approved Source,
Material Conform to Customer Drawing and Specifications.
Production Process: Particular process or methodology specified by the customer if any, were
followed.
Final Inspection: Test procedure or method as specified by the customer if any, were
followed or complied with.
Despatch: Lables with specific information like ROHS, or DOL (Indicating Direct On Line
which means the customer would directly issue to his production line without incoming
inspection at his end) as specified by the customer are followed or complied with.

V. Ramavallabhan Lead Auditor ISO 9001 (IRCA & RABQSA), ISO / TS 16949 (SMMT IF,
IATF & AIAG), AS 9100C (RABQSA), ISO 14001 (IEMA), OHSAS 18001 (IRCA) & ISO 50001
(BSI) and Process Auditor VDA 6.3 (VDA QMC)
Management and Technical Consultant, JVR Consultants, Chennai, India.
Mobile : +91-9840261401, Email: ram@jvrconsultants.net, Website : www.jvrconsultants.net