7.2.1 General
The supplier/manufacturer shall establish and maintain documented procedures to control all documents and data that relate to the requirements, including normative annexes of this part of ISO 17078. These documents and data shall be maintained to demonstrate conformance to specified requirements. All documents and data shall be legible and shall be sorted and retained in such a way that they are readily retrievable in facilities that provide a
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suitable environment to prevent damage or deterioration and to prevent loss. Documents and data may be in the form of any type of media, such as hard copy or electronic media. All documents and data shall be available and auditable by the user/purchaser.
7.2.2 Documentation requirements
The supplier/manufacturer shall have available a completed design file containing all the supplier/manufacturer’s required design validation testing procedures and design validation grade testing records, with verified acceptance of each. The file shall further contain test results and/or calculations that validate the design. The design packet shall be properly reviewed and approved by a qualified person other than the originator.
7.2.3 Documentation requirements for specific product design validation testing
There are three sets of requirements for the documentation of product design validation tests, one for each product design validation grade: V3, V2 and V1. These are identified in Table A.2 and the test requirement annexes to which Table A.2 refers. In some cases, the requirements in 7.2 are sufficient. In other cases, special documentation is required and is specified in the appropriate annexes.
7.2.4 Devices tested prior to date of publication of this part of ISO 17078
The requirements for documentation may be met for flow-control device products that existed before the publication of this part of ISO 17078 if the supplier/manufacturer can document that they successfully performed the required tests on these devices to meet the equivalent validation testing requirements, and that these tests have been approved by a qualified person. If the procedures are not the same as defined in this part of ISO 17078, the supplier/manufacturer shall provide written evidence of the suitability of the previous test procedure(s) to ensure that they meet or exceed these requirements.
7.2.5 Design documentation
The design validation test results shall be clearly identified as grade V3, V2 or V1.
The product functional test results shall be clearly identified as grade F3, F2 or F1.
All design documents, data, design validation test results and initial product functional test results in the following list shall be maintained for five years after the date of last manufacture:
a) functional and technical specifications;
b) supplier/manufacturer’s quality manual;
c) required grade of QC (quality control) documentation as specified in 5.8;
d) one complete set of drawings, written specifications and design calculations and standards;
e) instructions providing methods for the safe installation and use of the flow-control device. This document shall state the operations that are permitted and shall preclude those operations that can lead to failure and/or non- compliance with the functional and performance requirements;
f) material type, yield strength and connection identification for the actual end connection(s) provided with the flow-control device (where applicable);
g) welding procedure specification (WPS);
h) weld procedure qualification record (PQR);
i) welder/welding operator performance qualification (WPQ).
7.2.6 Product functional testing documentation 7.2.6.1 Test file
The supplier/manufacturer shall have available a complete test file containing all the supplier/manufacturer’s required product functional testing procedures and product functional test grade testing records, with verified acceptance of each. The file shall further contain test results and/or calculations that confirm the performance of the product(s) that have been tested.
7.2.6.2 Documentation requirements for specific product functional testing
There are three sets of requirements for documentation of product functional tests, one for each product functional testing grade: F3, F2 and F1. These are identified in Table A.2 and the test requirement annexes to which Table A.2 refers.
7.2.7 User/purchaser documentation
A product data sheet for each line item on each order shall be supplied upon delivery of the order to the user/purchaser, as required in the quality control grade.
NOTE The intent of this is to require a separate product data sheet for each unique product or set of products that is part of a specific design family.
The product sheet shall contain at least the following, as applicable:
a) name and address of supplier/manufacturer;
b) supplier/manufacturer assembly number;
c) supplier/manufacturer product name;
d) product type;
e) operational parameters as specified in 5.4;
f) metallic materials;
g) non-metallic materials;
h) overall length;
i) temperature range for rated pressure;
j) rated pressure;
k) top connection(s);
l) conveyance method;
m) maximum conveyance OD, inclusive of running equipment, as applicable;
n) retrieval method;
o) quality control grade;
p) design validation grade;
q) product functional testing grade;
r) technical/operations manual reference number.
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7.2.8 Technical/operations manual
A technical/operations manual shall be available for products supplied in accordance with this part of ISO 17078 and shall contain at least the following information:
a) manual reference number and revision level;
b) product data sheet;
NOTE An example product data sheet will be shown in ISO 17078-4, which is under development as of the date of publication of this part of ISO 17078.
c) operational procedures;
d) pre-installation inspection procedures;
e) storage recommendations;
f) representative drawing showing major dimensions (ODs, IDs, and lengths);
g) special precautions and handling;
h) list of all devices with which compatibility is claimed for the flow-control device.