API Spec. Q1 clause 5.6.1.2 On site evaluation

[SANTHSH]

Clause 5.6.1.2 C)of API spec. Q1, 9th edition, Addendum 2, states

"Assessment of the supplier to ensure its capability to meet the organisation's specified requirements by one or more of the following:

1) Performing an on-site evaluation of relevant activities; or

2) Performing first article (see 3.1.11) inspection to ensure conformance to stated requirements; or

3) Identifying how the supplied product, component, or activity conforms to stated requirements when limited by proprietary, legal and/or contractual arrangements."

Now that we are not in a position to do 'on-site assessment' because of the COVID-19 pandemic and our company's policy doesn't allow placement a trial order and carrying out 'first article inspection' (during re-evaluation), is it good enough if we conduct a remote audit of our Suppliers through video conferencing ? Will it be accepted by API ?

N.B: Even our API re-certification audit for renewal of monogram licenses pertaining to Oil Field Equipment was carried out in remote mode by API.

 

[jmech]

Probably. Any reasonable auditor should accept it, but it is not guaranteed that your auditor will be reasonable. The safest route is to email API to ask them to confirm that this is acceptable.

 

[jmech]

I should add that using your MOC process to control this change will increase the likelihood that it is accepted without a finding.

This might be considered a "change to the management system procedures" that "may negatively impact the quality of product" (if your remote assessment is less effective than an on-site assessment, you may be more likely to receive nonconforming product from your supplier), so MOC could be required per Q1 9th Edition 5.11.2.

 

[Tomballd]

I included the remote evaluation in our QMS and API Auditor didnt bat an eye at this during our audit in December, I couldnt see API doing remote audits and not accept this at this point.

 

[Thee Bouyyy]

Clause 5.6.1.2 C)of API spec. Q1, 9th edition, Addendum 2, states

"Assessment of the supplier to ensure its capability to meet the organisation's specified requirements by one or more of the following:

1) Performing an on-site evaluation of relevant activities; or

2) Performing first article (see 3.1.11) inspection to ensure conformance to stated requirements; or

3) Identifying how the supplied product, component, or activity conforms to stated requirements when limited by proprietary, legal and/or contractual arrangements."

Now that we are not in a position to do 'on-site assessment' because of the COVID-19 pandemic and our company's policy doesn't allow placement a trial order and carrying out 'first article inspection' (during re-evaluation), is it good enough if we conduct a remote audit of our Suppliers through video conferencing ? Will it be accepted by API ?

N.B: Even our API re-certification audit for renewal of monogram licenses pertaining to Oil Field Equipment was carried out in remote mode by API.

Add remote auditing option in your QMS. The auditor can not challenge that because you have written in your QMS. We are using the same method. We have included in our Purchase SOP and forms. We are using two options like A - On site audit and B - Desk audit (when site audit is not possible).

 

[Sidney Vianna]

Add remote auditing option in your QMS. The auditor can not challenge that because you have written in your QMS.

So, if you write that you can audit your supplier by remote viewing or telepathy, that would it make it acceptable?

QMS - is NOT saywhatyoudodowhatyousay.

 

[Thee Bouyyy]

So, if you write that you can audit your supplier by remote viewing or telepathy, that would it make it acceptable?

QMS - is NOT saywhatyoudodowhatyousay.

Yes, of course. We are located in India and we have abroad suppliers available. So, it is not possible to go and visit abroad supplier every time. That will be costly for our company. To avoid this, we have added the Remote / Desk audit option in our QMS. Till now, no one challenged us on this.

And now everyone is aware of this COVID-19 pandemic, this will be a good option to conduct a remote audit. Even API is started to do so. We recently faced an API remote audit on 28th to 31st Dec 2020.

Desk / remote audit reports we have shown to the auditor and he didn't question us.

 

[Sidney Vianna]

We are located in India and we have abroad suppliers available. So, it is not possible to go and visit abroad supplier every time. That will be costly for our company.

Please note that API Spec Q1 5.6.1.2 offers alternatives to a critical supplier on-site audit, such as a thorough FIRST ARTICLE INSPECTION. In some cases, this FAI, together with a remote audit, could be an effective solution.

Desk / remote audit reports we have shown to the auditor and he didn't question us.

The next API auditor might question it, as we all know the level of inconsistency among auditors out there.

 

[Thee Bouyyy]

Please note that API Spec Q1 5.6.1.2 offers alternatives to a critical supplier on-site audit, such as a thorough FIRST ARTICLE INSPECTION. In some cases, this FAI, together with a remote audit, could be an effective solution.

Yes, it is. What we have done in our QMS like this,

Step 1 - Verification of supplier quality management system - like ISO, API, or other equivalents.
Step 2 - On site audit or Desk audit (when site audit is not possible)
Step 3 - 1st article inspection / Proprietary product

The next API auditor might question it, as we all know the level of inconsistency among auditors out there.

Yes, but we are not running our company business as per auditor inconsistency. We have our QMS system and this is our business and we are not violating any Q1 clauses.

 

[pilchard]

Remember - Initial evaluation, for purchase of critical products, components or activities, I think they will let you slide under these circumstances as they API is limited and cannot do site assessments themselves, put in a projection on when it will be done after restrictions are lifted i.e. audit schedule.