Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization

#1
Hello all ,

Use of External Documents 4.4.4 in Product Realization
When API product or other industry specification requirements, including addenda, errata and updates, are used in the design or manufacture of the product, the organization shall maintain a documented procedure for the integration of these requirements into the product realization process and any other affected processes.

We have a Document and Data Control Procedure that defines the works and methods of defining, preparing, controlling, approving, publishing, revising and canceling the documents in our Integrated Management System. What can I adding for revised? I don't know what to write

Does anyone have procedures or information?

Thank you
 
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jmech

Trusted Information Resource
#2
Based on the title of your post, you are likely trying to resolve an audit nonconformance. If so, I recommend posting the whole nonconformance and a description of how you were trying to meet the requirement at the time of the audit.
 
#3
Objective Evidence1.The Quality manual refers to the procedure Pr. KGS 02.04 rev.04, but no documented method for integration of external requirements presented in the procedure
Nonconformance/Concern Description1.The Quality manual refers to the procedure Pr. KGS 02.04 rev.04, but no documented method for integration of external requirements presented in the procedure

The methods for document changes that may occur in our system are available in the Document Data Control Procedure. The auditor did not consider the content of the procedure appropriate.


We wrote the following information to the procedure:

The Quality Unit Manager and the IMS Specialist will provide you with all of the documentation pertaining to IMS once a year; the activities, standards, legal requirements and the system are reviewed for efficiency and efficiency.
External Resources;
Externally sourced documents are supplied externally by the units in need. The related units are responsible for the distribution of these documents, the revision monitoring and revision procedures, and the maintenance of these documents. It is followed by List of Foreign Documents
Document from Customers;
Technical drawings, specifications, specifications, engineering instructions, inspection and test instructions, etc. from customers are documents. These documents are reviewed by the unit responsible and controlled by the Technical Affairs Director.
Standards, Periodicals
The procedures applied to the Standards, Laws and Periodicals are explained in the Legal and Other Conditions Procedure Stand
 

jmech

Trusted Information Resource
#4
The auditor appears to be correct: your procedure doesn't describe how requirements from external documents are integrated into your processes. You don't just have to review/maintain/control a copy of external documents; you have to ensure that your processes meet the applicable requirements from these documents, and your procedure needs to describe how you do this.

For example, if you make API 6A valves, simply maintaining a copy of 6A is not enough - you need to integrate the 6A requirements into your product realization process to ensure that your valves conform to 6A.

If you are producing a product to an API spec, how do you ensure that your product meets all the API spec requirements?
 
#5
The auditor appears to be correct: your procedure doesn't describe how requirements from external documents are integrated into your processes. You don't just have to review/maintain/control a copy of external documents; you have to ensure that your processes meet the applicable requirements from these documents, and your procedure needs to describe how you do this.

For example, if you make API 6A valves, simply maintaining a copy of 6A is not enough - you need to integrate the 6A requirements into your product realization process to ensure that your valves conform to 6A.

If you are producing a product to an API spec, how do you ensure that your product meets all the API spec requirements?
Okey. I understood. Tahnks for informations
 
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