API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4

#1
We received an NC that Supplier re-evaluation frequency is not based on supplier risks ( API Spec Q1 5.6.1.4) and the controls on sub-supplier are not evident ( 5.6.1.2 b). Ps, give inputs on answering the NC'srelated to the purchasing process. Thanks
 
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Thee Bouyyy

Involved In Discussions
#3
We received an NC that Supplier re-evaluation frequency is not based on supplier risks ( API Spec Q1 5.6.1.4) and the controls on sub-supplier are not evident ( 5.6.1.2 b). Ps, give inputs on answering the NC'srelated to the purchasing process. Thanks
Agreed with pilchard. You have to define first critical and non-critical suppliers. For e.g Casting suppliers falls under critical supplier - Set re-evaluation frequency 01 Year and Cotton waste suppliers falls under non-critical supplier - Ser re-evaluation frequency 02 or 03 years.
 

lanley liao

Involved In Discussions
#4
Agreed with Pilchard and Three Bouyyy.In fact, this question includes the risk assessment and management and contingency planning of suppliers. especially the critical suppliers, it will affect delivering a product to the customer on time if the critical supplier stops and supply the material. so you need to do a risk assessment and management as well as contingency planning for the critical suppliers. the written investigation, on-site capability evaluation, sample testing, and small lot trial may be carried out by us to the critical supplier. whereas, we only may need to written investigation and on-site capability evaluation. We may need to quality inspection certificate for the critical suppliers, instead, no need for non-critical suppliers. In the sample planning of incoming material, the AQL values should be small a little for critical suppliers, but the AQL values should be big a little for non-critical suppliers and so on. so we should classification and control our suppliers according to critical suppliers and noncritical suppliers.
 
#5
You need to set a criticality of the supplier i.e. critical or non critical and base your frequency on the criticality, more often evaluations or audits for critical than non critical and sub suppliers need to be on your approve vendor list.
We already have critical and non-critical supplier list but we didn't establish supplier revaluation frequency based on supplier risks.
 
#6
We already have critical and non-critical supplier list but we didn't establish supplier revaluation frequency based on supplier risks.
Since 5.6.1.3 is the parameters for revaluation of critical and non critical suppliers, a) is usually a questionnaire and you can vary it like annually for critical and every 3 years for non critical, with a caveat for repeated nonconformance's or one or b) assessment of the supplier to meet the organization's purchasing requirements if you have a history of your suppliers and if you have a nonconformance(s) that could be a frequency to reevaluate, or c) assessment of the product upon delivery or activity upon completion, if you have a receiving inspection that is assessing the supplier constantly and if you have nonconformance(s) that could be a frequency kinda like b)
 

jmech

Trusted Information Resource
#7
Since 5.6.1.3 is the parameters for revaluation of critical and non critical suppliers
Since Q1 9th Ed Addendum 2 (published June 2018, effective June 2019), this is no longer true. Per the addendum, 5.6.1.4 has been replaced with the following:
The organization shall determine the supplier reevaluation frequency based on supplier risk and supplier quality performance.
For the reevaluation of suppliers of critical products, components or activities, the requirements of 5.6.1.2 shall apply.
For the reevaluation of suppliers of noncritical products, components or activities, the requirements of 5.6.1.3 shall apply.
 
#8
Since Q1 9th Ed Addendum 2 (published June 2018, effective June 2019), this is no longer true. Per the addendum, 5.6.1.4 has been replaced with the following:
The organization shall determine the supplier reevaluation frequency based on supplier risk and supplier quality performance.
For the reevaluation of suppliers of critical products, components or activities, the requirements of 5.6.1.2 shall apply.
For the reevaluation of suppliers of noncritical products, components or activities, the requirements of 5.6.1.3 shall apply.
Thanks
 
#9
Thanks for all the valuable inputs. Very much appreciated. To assess Supplier Risks shall I take into consideration risks related to Quality, Product delivery/Service, Single supplier, QMS certification, Finance strength, Cost etc., and give a possible rating for each? Based on risk rating the frequency of reevaluation can be fixed. Is this the right approach? Ps, let me know.
 

Thee Bouyyy

Involved In Discussions
#10
Thanks for all the valuable inputs. Very much appreciated. To assess Supplier Risks shall I take into consideration risks related to Quality, Product delivery/Service, Single supplier, QMS certification, Finance strength, Cost etc., and give a possible rating for each? Based on risk rating the frequency of reevaluation can be fixed. Is this the right approach? Ps, let me know.
Yes, This is right approach. Q1 5.6.1.4 within itself says that "The organization shall determine ......" So, you as an organization has to define the criteria of risks. So, yeah rating system based on Quality, Product delivery/Service, Single supplier, QMS certification, Finance strength, Cost etc. would be right approach to define frequency.
 
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