1.

0 PROCEDURE ON USE OF EXTERNAL DOCUMENTS IN PRODUCT REALIZATION

2.0 PURPOSE:

 To detail the procedure on use & integration of external documents in product realization.

3.0 SCOPE:

 This procedure covers the requirements of API Spec.Q1 9th edition, API 6D & API 600.
 Integration of external documents including API product or other external specifications
including addenda, errata & updates in product realization processes.

4.0 RESPONSIBILITY:

 V.P.(Operations)
 Head ( Design)- Direct responsibility (Process owner)
 Head (QA/QC)
 Respective departmental head

5.0 REFERENCE DOCUMENTS:

 Procedure on Design & development (PRO/DD/5.4)

 Procedure on control of documents (PRO/MR/4.4.3)
 API spec 6D ,API 600 & related specifications
 Product quality plan / QAPs

6.0 PROCEDURE:

In case of use of API related product or other external specification requirements including their
addenda, errata or updates if any to be used in the design, development & manufacture of the
product the integration of such requirements shall be considered into product realization process
or any other affected process in the following manner:

I. Identification of inputs for the product realization:

 HOD (Design) is overall responsible for this process.

 On receipt of API or other external specifications including errata’s, addenda & updates by
the organization the HOD (Design) updates the list of external origin documents.

 For identification of inputs required to be incorporated & integrated in the product

realization processes he interacts & forms a committee headed by the V.P.(Operations) with
participation of Heads from all departments .This committee shall review the external origin

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 & other applicable documents including all product, processes, systems & other applicable
specifications in one or more meetings on pre-planned arrangements.

 The committee shall identify and list out various requirements department wise needed to be
integrated in the existing processes. Such requirements shall be intimated to each
departmental head for time bound processing/completion as per procedure on MOC through
involvement of MR.

II. Implementation of inputs for product realization:

 Respective head of department thereafter shall forward such requirements to MR for
processing/implementation as per procedure of Management of Change.

 MR thereafter shall carry out the risk assessment as per the procedure for Risk assessment &
management for any potential risk involved for effecting such changes. Such assessment shall
be carried out by MR in association with the related departmental head(s).

 In case of actionable potential risk assessed, the recommended action shall be taken to
mitigate the risk to acceptable level as per procedure by respective HOD and records
maintained. On mitigation of risk to acceptable level the related HOD shall communicate with
MR for taking further action.

 In case of no tangible potential risk observed in integration of the activity /process or on

mitigation of assessed risk to the acceptable level a detailed action plan shall be made by MR
in association with related departmental Head(s) highlighting specific activities, responsibility
,resource requirement & time frame required to implement the identified changes in various
processes, documents & products. The said plans shall be reviewed by VP (Operations) &
approved by Managing Director for time bound implementation.

 The implementation of changes/approved plans shall be made as per procedure on

management of change by the respective departmental head & necessary records
maintained. The changes where ever required shall be affected in the documents, processes
& systems and necessary updates carried out as per related procedures.

 Based on revised requirements & documents the respective Heads of departments shall plan
& carry out their respective product realization processes as per applicable procedures &
shall maintain the necessary records.

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 In case of any specific external document of customer for use in the product design &
development it will be reviewed by VP(Operations) for its suitability & if approved it will be
used in design & development of the product as per procedure on Design & development.

 In case of use of external document for any specific production process or

quality/testing/monitoring or measurement the same process of approval by HOD(QA/QC)
shall be required followed by revising the process criteria’s & test/inspection procedures,
their approval & implementation by the respective departmental head.

 MR & respective departmental heads shall be responsible for the processes related to their
areas and also will maintain the records of such documents & process of management of
change and implementation.MR thereafter shall intimate the results of action taken to HOD
(Design) for record.

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