H
HRMaribeth
Hello Everyone:
Working on a nonconformity from our most recent API Audit. Struggling....
To get you on board, I am copying and pasting the entire conversations between us (the company) and API to try and clear this up. As many of you may know, API will not consult you to help you get the answers/evidence they really want from you (which makes it difficult), it's like playing a game between them and us and a lot of going back and forth to get to the right answer.
Enough of that. I can't figure out what we need to get from our vendors/suppliers to show conformity to this one. If anyone has had experience with this one and could help me out... I would so appreciate it! :.
Here is all the info related to this NCR. It starts from the oldest and ends with the most recent response.
[FONT="]AAR Number 9:[/FONT][FONT="] 7.5.2.1 -- The org shall validate those processes identified by the applicable product specification as requiring validation. If these processes are not identified, or there is no product specification involved, the processes requiring validation shall include, as a minimum, non-destructive examination, welding and heat treating, if applicable to the product. [/FONT]
[FONT="]Definition: Validation[/FONT]
[FONT="]NCR ? No record of qualification requirements for personnel performing an outsourced carburizing was found. [/FONT]
[FONT="]Correction: [/FONT][FONT="]Retrieve qualification records from vendors we outsource our processes with[/FONT][FONT="].[/FONT]
[FONT="]Root Cause: [/FONT][FONT="]Misinterpretation of the standard.[/FONT]
[FONT="]Corrective Action: [/FONT][FONT="]Retrieved personnel required qualifications from Vendors and is now documented in vendor files[/FONT][FONT="].[/FONT]
[FONT="]Response from API:[/FONT]
[FONT="]1. [/FONT][FONT="]Submit evidence of the ?carburizing? validation performed by your supplier in accordance with Spec Q1, 7.4.1.3.[/FONT]
[FONT="]2. [/FONT][FONT="]Did you review any other suppliers providing processes that require validation? What was the result of the review? [/FONT]
[FONT="]3. [/FONT][FONT="]Your root cause requires further clarification. Provide a ?detailed? explanation of the cause of the nonconformity. Why was the standard misinterpreted?[/FONT]
[FONT="]4. [/FONT][FONT="]Your corrective action is not accepted. What actions have you implemented to minimize the likelihood of recurrence?[/FONT]
[FONT="]Our Responses:[/FONT]
[FONT="]1. [/FONT][FONT="]Submit evidence ? [/FONT]
[FONT="]2. [/FONT][FONT="]Yes. No other suppliers require validation. [/FONT]
[FONT="]3. [/FONT][FONT="]We thought qualifications of vendors was checked during final inspection and we thought this process to be sufficient to validate the product conformance.[/FONT]
[FONT="]4. [/FONT][FONT="]We have added API criteria to our part numbers within our business system which will trigger required validation on all API materials received back from vendor.[/FONT]
[FONT="]Response from API:[/FONT]
[FONT="]1. [/FONT][FONT="]I couldn?t find the evidence demonstrating compliance with API Spec Q1, Clause 7.5.2 and 7.4.1.3. Please submit all the requested information.[/FONT] [FONT="]Per 7.5.2; We have the in-house capability to validate the subsequent monitoring and measurement of suppliers to validate their process. See example (carburizing in-house validation) of our validation of outsourced carburizing process.[/FONT]
[FONT="]Ivan E. Pinto (9/20/2013 10:30:41 AM)[/FONT][FONT="]:
Notice that a hardness inspection performed at your location cannot ensure the process was adequate to maintain a homogeneous grain structure and proper chemical and mechanical properties. Your supplier must validate the carburization process in accordance with API Spec Q1, 7.4.1.3. The validation should include:
- defined criteria for review and approval of the processes,
- approval of equipment and qualification of personnel,
- use of specific methods and procedures,
- requirements for records, and
- revalidation.
1. Your customers must be notified about the lack of a validated process. Submit evidence.
2. Provide detailed corrective actions to minimize the likelihood of recurrence.[/FONT]
[FONT="]Our Response:[/FONT]
[FONT="]After careful review, we understand this NCR to be related to our internal process for Supplier Qualification; QSP 7.40 (attached) This procedure has been in place since 2008 and revised 10/30/09 to comply with API requirements. This is our process for validating our outsourced processes up to and including personnel qualifications. [/FONT]
[FONT="]For your review, please find QSP 7.40, Form F-008; Supplier Evaluation, and also a vendor Certificate of Registration to ISO 9001-2008 attached.[/FONT]
API Respone:
Ivan E. Pinto (10/14/2013 9:49:04 AM):
Your evidence is related to ?supplier qualification?. Notice that your organization is required to ?validate processes? by API Spec Q1, 7.4.1.3 & 7.5.2.
- defined criteria for review and approval of the processes,
- approval of equipment and qualification of personnel,
- use of specific methods and procedures,
- requirements for records, and
- revalidation.
1. Your customers must be notified about the lack of a validated process. Submit evidence.
2. Provide detailed corrective actions to minimize the likelihood of recurrence.
Working on a nonconformity from our most recent API Audit. Struggling....
To get you on board, I am copying and pasting the entire conversations between us (the company) and API to try and clear this up. As many of you may know, API will not consult you to help you get the answers/evidence they really want from you (which makes it difficult), it's like playing a game between them and us and a lot of going back and forth to get to the right answer.
Enough of that. I can't figure out what we need to get from our vendors/suppliers to show conformity to this one. If anyone has had experience with this one and could help me out... I would so appreciate it! :.
Here is all the info related to this NCR. It starts from the oldest and ends with the most recent response.
[FONT="]AAR Number 9:[/FONT][FONT="] 7.5.2.1 -- The org shall validate those processes identified by the applicable product specification as requiring validation. If these processes are not identified, or there is no product specification involved, the processes requiring validation shall include, as a minimum, non-destructive examination, welding and heat treating, if applicable to the product. [/FONT]
[FONT="]Definition: Validation[/FONT]
[FONT="]NCR ? No record of qualification requirements for personnel performing an outsourced carburizing was found. [/FONT]
[FONT="]Correction: [/FONT][FONT="]Retrieve qualification records from vendors we outsource our processes with[/FONT][FONT="].[/FONT]
[FONT="]Root Cause: [/FONT][FONT="]Misinterpretation of the standard.[/FONT]
[FONT="]Corrective Action: [/FONT][FONT="]Retrieved personnel required qualifications from Vendors and is now documented in vendor files[/FONT][FONT="].[/FONT]
[FONT="]Response from API:[/FONT]
[FONT="]1. [/FONT][FONT="]Submit evidence of the ?carburizing? validation performed by your supplier in accordance with Spec Q1, 7.4.1.3.[/FONT]
[FONT="]2. [/FONT][FONT="]Did you review any other suppliers providing processes that require validation? What was the result of the review? [/FONT]
[FONT="]3. [/FONT][FONT="]Your root cause requires further clarification. Provide a ?detailed? explanation of the cause of the nonconformity. Why was the standard misinterpreted?[/FONT]
[FONT="]4. [/FONT][FONT="]Your corrective action is not accepted. What actions have you implemented to minimize the likelihood of recurrence?[/FONT]
[FONT="]Our Responses:[/FONT]
[FONT="]1. [/FONT][FONT="]Submit evidence ? [/FONT]
[FONT="]2. [/FONT][FONT="]Yes. No other suppliers require validation. [/FONT]
[FONT="]3. [/FONT][FONT="]We thought qualifications of vendors was checked during final inspection and we thought this process to be sufficient to validate the product conformance.[/FONT]
[FONT="]4. [/FONT][FONT="]We have added API criteria to our part numbers within our business system which will trigger required validation on all API materials received back from vendor.[/FONT]
[FONT="]Response from API:[/FONT]
[FONT="]1. [/FONT][FONT="]I couldn?t find the evidence demonstrating compliance with API Spec Q1, Clause 7.5.2 and 7.4.1.3. Please submit all the requested information.[/FONT] [FONT="]Per 7.5.2; We have the in-house capability to validate the subsequent monitoring and measurement of suppliers to validate their process. See example (carburizing in-house validation) of our validation of outsourced carburizing process.[/FONT]
[FONT="]Ivan E. Pinto (9/20/2013 10:30:41 AM)[/FONT][FONT="]:
Notice that a hardness inspection performed at your location cannot ensure the process was adequate to maintain a homogeneous grain structure and proper chemical and mechanical properties. Your supplier must validate the carburization process in accordance with API Spec Q1, 7.4.1.3. The validation should include:
- defined criteria for review and approval of the processes,
- approval of equipment and qualification of personnel,
- use of specific methods and procedures,
- requirements for records, and
- revalidation.
1. Your customers must be notified about the lack of a validated process. Submit evidence.
2. Provide detailed corrective actions to minimize the likelihood of recurrence.[/FONT]
[FONT="]Our Response:[/FONT]
[FONT="]After careful review, we understand this NCR to be related to our internal process for Supplier Qualification; QSP 7.40 (attached) This procedure has been in place since 2008 and revised 10/30/09 to comply with API requirements. This is our process for validating our outsourced processes up to and including personnel qualifications. [/FONT]
[FONT="]For your review, please find QSP 7.40, Form F-008; Supplier Evaluation, and also a vendor Certificate of Registration to ISO 9001-2008 attached.[/FONT]
API Respone:
Ivan E. Pinto (10/14/2013 9:49:04 AM):
Your evidence is related to ?supplier qualification?. Notice that your organization is required to ?validate processes? by API Spec Q1, 7.4.1.3 & 7.5.2.
- defined criteria for review and approval of the processes,
- approval of equipment and qualification of personnel,
- use of specific methods and procedures,
- requirements for records, and
- revalidation.
1. Your customers must be notified about the lack of a validated process. Submit evidence.
2. Provide detailed corrective actions to minimize the likelihood of recurrence.