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API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
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API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers
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API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers


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  Post Number #1  
Old 8th December 2017, 08:54 AM
Nescio1967

 
 
Total Posts: 2
Please Help! API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers

API Spec Q2 states in the last paragraph of clause 6.2.2.1: Outsourced suppliers that impact the quality of services or service-related product, located at the organizationís facility, shall be included as part of the internal audit of the organization.

So now my question is if this is only applicable if the outsourced supplier is located at the organizationís facility or also when they occasionally perform services at the organizationís facility.

Thanks,
Nes

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  Post Number #2  
Old 8th December 2017, 01:13 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,347
Re: API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers

It seems odd that the scope of an internal audit would include an in-house outside supplier. But, as the standard is unclear about external suppliers which are in house intermittently, to be safe, I would schedule an audit of the supplier while they are at your premises, just in case.
Thanks to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #3  
Old 8th December 2017, 02:27 PM
Eredhel

 
 
Total Posts: 273
Re: API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers

Quote:
In Reply to Parent Post by Nescio1967 View Post

API Spec Q2 states in the last paragraph of clause 6.2.2.1: Outsourced suppliers that impact the quality of services or service-related product, located at the organizationís facility, shall be included as part of the internal audit of the organization.

So now my question is if this is only applicable if the outsourced supplier is located at the organizationís facility or also when they occasionally perform services at the organizationís facility.

Thanks,
Nes
I'm familiar with and have Q1, but I don't know Q2. Would you be able to quote the actual language? It almost looks like they're saying "outside suppliers that have an impact on stuff located at your facility". I'm completely guessing though since I'm only familiar with Q1.
  Post Number #4  
Old 8th December 2017, 02:29 PM
Eredhel

 
 
Total Posts: 273
Re: API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers

Here's the Q1 language:

"Outsourced activities that impact the quality of the product and that are performed at the organization’s facility shall be included as part of the internal audit of the organization."

But this is for the internal audit only.
Thanks to Eredhel for your informative Post and/or Attachment!
  Post Number #5  
Old 11th December 2017, 01:51 PM
Nescio1967

 
 
Total Posts: 2
Re: API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers

Sorry for the late response but find below the original text from API Spec Q2.

6.2.2 Internal Audit

6.2.2.1 General
The organization shall maintain a documented procedure to define responsibilities for planning and conducting internal audits. The planning of internal audits shall take into consideration the results of previous audits and criticality of the process.

The organization shall define the audit criteria, scope, frequency, and methods to ensure that all elements of the management system claiming conformity to the requirements of this document are audited at least annually.

Outsourced suppliers that impact the quality of services or service-related product, located at the organizationís facility, shall be included as part of the internal audit of the organization.
  Post Number #6  
Old 12th December 2017, 07:00 PM
Eredhel

 
 
Total Posts: 273
Re: API Q2 clause 6.2.2.1 Auditing Outsourced Suppliers

I'm not an API expert but I think Sidney has a good approach. Be proactive and audit them while they're there sometime. I bet you could contact API for clarification, especially since they don't let anyone else to certification audits.
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