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1 and make a
recommendation to the Sub Task group for HPHT
Com
Per 15K-1 , 5.5.8 Manufacturing Process Specification
5.5.8.1 Responsibility
The manufacturer should prepare a written manufacturing process specification (MPS) as well as a written inspection and
testing plan (ITP).
The MPS should describe in detail the individual steps or actions required to manufacture or fabricate each piece of
equipment that is produced under this specification.
Likewise, the ITP should describe each inspection or test that will be performed on the equipment "in process" and for final
acceptance. The ITP should show the acceptable ranges for dimensions, materials properties, and other equipment
characteristics that are required at each stage of the manufacturing process. It should also indicate hold points in the
manufacturing and inspection/testing plans and whether each inspection or test is to be reviewed, monitored, or witnessed
by authorized representatives of the manufacturer, the user, or third party.
The MPS and ITP should be submitted to the user for review and modified as necessary, prior to the commencement of
manufacturing or fabrication.
The user should conduct a timely review of the MPS and ITP and should signify acceptance of the MPS and ITP in writing.
The MPS and ITP should not be changed following acceptance, except by written agreement between of the manufacturer
and the user.
CONCLUSION
ISO 10005 gets into far greater detail than section 5.5.8.1 for example: (a) Control of records (b) Control of documents and
data (c) infrastructure and work environment etc. are all covered in ISO 10005 and provide a 'greater assurance that
processes are in control and the motivation it can give to those invovled.'
A company with a QMS compliant to ISO 9001 / API Q1 will not necessarily require Control Plans in all cases since section
7.1 makes it optional.
Based on a review of other Standards, Control Plans can be used to apply to the entire product realization process (as in
5C5) or in specific manufacturing processes (as in 5CT and 5DP)
Section 7.6 (Quality Control) of ISO 10432 already contains a great deal of material (mostly relevant to ISO 10005 Clause
5.18 Monitoring and measurement and some compliance with section 5.8.3 Human resources) that would be the content of a
Quality Plan. Since these are already in the body of ISO 10432, these are Normative requirements to all SSSV.
For HPHT equipment, it is recommended to add a phrase to the new Annex to be created as follows:
The manufacturer should prepare a written Quality Plan pursuant to ISO 10005.
The Quality Plan shall contain all the requirements outlined in section 7.6 and any other requirements of ISO 10005.
The Quality Plan should be submitted to the user for review and modified as necessary prior to the commencement of
manufacturing or fabrication.
The user should conduct a timely review of the Quality Plan and should signify acceptance of the Quality Plan in writing.
The Quality Plan should not be changed following acceptance, except by written agreement between of the manufacturer
and the user.
2/28/2011:
Sub TG for HPHT recommends to remove the phrase "prior to the commencement of manufacturing or fabrication."
The recommended phrase will be:
The manufacturer should prepare a written Quality Plan pursuant to ISO 10005.
The Quality Plan shall contain all the requirements outlined in section 7.6 and any other requirements of ISO 10005.
The Quality Plan should be submitted to the user for review and compliance demonstrated prior to shipment.
The user should conduct a timely review of the Quality Plan and should signify acceptance of the Quality Plan in writing.
The Quality Plan should not be changed following acceptance, except by written agreement between of the manufacturer
and the user.
3/8/2011
The supplier/manufacturer shall prepare and the user/purchaser shall approve in writing a quality plan conforming to the
requirements of ISO 10005 and 7.6 for each order placed. Changes to the approved quality plan shall be further approved by
the same process as used for the original plan. The quality plan shall become a part of the products manufacturing file. "
5.18 Monitoring and measurement covers all the requirements of this section
6.1 Review and acceptance of the quality plan covers all the requirements of this section
6.1 Review and acceptance of the quality plan covers all the requirements of this section
6.3 Revision of the quality plan covers all the requirements of this section
Comments
ISO 10005 exceeds requirements
ISO 10005 exceeds requirements