Supplier re-evaluation (API Q1)

#1
Is it mandatory to do supplier re-evaluation on annual basis? API Q1 clause 5.6.1.4 says that organizations shall perform supplier re-evaluation; however, it doesn't specify the frequency.
I'll be straight with my question. will it satisfy API auditors if a company performs supplier re-evaluation for example every 2 or 3 years?
a company might be having a very long list of suppliers and the evaluation might be time consuming. some suppliers are only used once.
 
Elsmar Forum Sponsor

JoshuaFroud

Involved In Discussions
#2
If it does not say it in the standard then usually as long as you justify your decisions it is accepted.

I work under 9001 and 13485 (Quality Management Systems and QMS for Medical Devices), making a raditation emitting product. Our supplier audit plans are 3 years for an audit with an annual "review" conducted.

This annual review is a short paperwork check that they supplier is peforming as expected, e.g. no sudden increase in failures in recieved goods/services. If the review shows no change we carry on with the 3 year plan, if the review shows a change a risk assessment is done and the audit may be brought forward depending on the risk to the final product based on the product or service that company provides.

With this system we have not have a problem with any audits.
 

jmech

Trusted Information Resource
#3
There is no requirement in API Q1 that the supplier reevaluation frequency be annual.

However, note the new requirement that was added in Addendum 2 to Q1 9th Edition: "The organization shall determine the supplier reevaluation frequency based on supplier risk and supplier quality performance."

If you set the reevaluation frequency for all suppliers to 2 or 3 years, the auditor will likely write a finding for not meeting this clause.

If you set the reevaluation frequency for your high risk suppliers to 3 years and the frequency for low risk suppliers to 5 years, and find a way to mix "supplier quality performance" into the frequency determination, you would meet the requirement, but the auditor would likely be dissatisfied and try to look for a way to write a finding (or at least a concern).

If you set the reevaluation frequency for your high risk suppliers to 1 year (or more frequently) and the frequency for low risk suppliers to 2 or 3 years, and add adjustment factors based on supplier quality performance, it should satisfy the auditor.
 
#4
There is no requirement in API Q1 that the supplier reevaluation frequency be annual.

However, note the new requirement that was added in Addendum 2 to Q1 9th Edition: "The organization shall determine the supplier reevaluation frequency based on supplier risk and supplier quality performance."

If you set the reevaluation frequency for all suppliers to 2 or 3 years, the auditor will likely write a finding for not meeting this clause.

If you set the reevaluation frequency for your high risk suppliers to 3 years and the frequency for low risk suppliers to 5 years, and find a way to mix "supplier quality performance" into the frequency determination, you would meet the requirement, but the auditor would likely be dissatisfied and try to look for a way to write a finding (or at least a concern).

If you set the reevaluation frequency for your high risk suppliers to 1 year (or more frequently) and the frequency for low risk suppliers to 2 or 3 years, and add adjustment factors based on supplier quality performance, it should satisfy the auditor.
As per addendum 2, For Re evaluation assessment shall be as per critical items evaluation...

Is it required re evaluation need to do before effective date 2019 june for all suppliers as per addendum 2 new requirement.
 

jmech

Trusted Information Resource
#5
As per addendum 2, For Re evaluation assessment shall be as per critical items evaluation...

Is it required re evaluation need to do before effective date 2019 june for all suppliers as per addendum 2 new requirement.
Addendum 2 requires that re-evaluation of suppliers of critical products, components, and activities (critical suppliers) to meet the same requirements as initial evaluation of critical suppliers.

It is not clear whether this would result in requiring all critical suppliers to be evaluated to this requirement before the June 2019 effective date of Addendum 2, but I would not be surprised if API interprets it this way. If you are concerned, I recommend either contacting API to ask them or completing your re-evaluations of all critical suppliers before your next API audit.
 
#6
Addendum 2 requires that re-evaluation of suppliers of critical products, components, and activities (critical suppliers) to meet the same requirements as initial evaluation of critical suppliers.

It is not clear whether this would result in requiring all critical suppliers to be evaluated to this requirement before the June 2019 effective date of Addendum 2, but I would not be surprised if API interprets it this way. If you are concerned, I recommend either contacting API to ask them or completing your re-evaluations of all critical suppliers before your next API audit.
Thank you very much
 
#7
Addendum 2 requires that re-evaluation of suppliers of critical products, components, and activities (critical suppliers) to meet the same requirements as initial evaluation of critical suppliers.

It is not clear whether this would result in requiring all critical suppliers to be evaluated to this requirement before the June 2019 effective date of Addendum 2, but I would not be surprised if API interprets it this way. If you are concerned, I recommend either contacting API to ask them or completing your re-evaluations of all critical suppliers before your next API audit.
Hai can you help me in this.. We have certifications API 12J, 12F, 2B, 650..but we don't have products for 12F and 2B.We are planning to exclude those certificates. How to present in manual in Exclusions and there is a statement that basis for claiming exclusions shall be identified.. What does it mean? Can u please explain?
 

jmech

Trusted Information Resource
#8
Hai can you help me in this.. We have certifications API 12J, 12F, 2B, 650..but we don't have products for 12F and 2B.We are planning to exclude those certificates. How to present in manual in Exclusions and there is a statement that basis for claiming exclusions shall be identified.. What does it mean? Can u please explain?
You are only supposed to have licenses for products that you manufacture. If you don't make anything under 12F or 2B, you should drop those licenses. You cannot claim an exclusion for licenses that you have.

Design and development exclusions are permissible for the products on API Advisory 6, with the basis that Advisory 6 allows that exclusion (generally based on the logic that those products are fully defined by an API standard and no design is required by the organization to make those products).

Other exclusions may be claimed for some of the API Q1 requirements if the requirements are not relevant to the organization. For example, you can exclude clauses on servicing property if your organization never performs servicing. However, you cannot exclude servicing if your organization performs servicing.
 
#9
Hai sir,
Welding validation means, can i say PQR qualification with supporting documents and Re validation means, ASME code changes.. can they convince in this way.
 
Thread starter Similar threads Forum Replies Date
A API Q1 5.6.1.2 - Initial Supplier Evaluation Oil and Gas Industry Standards and Regulations 9
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
R Supplier evaluation and business needs in the context of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Supplier Audit Assessment / Evaluation Forms IATF 16949 - Automotive Quality Systems Standard 1
S Evaluation of Supplier / Sole supplier Supplier Quality Assurance and other Supplier Issues 5
P Supplier (Vendor) Evaluation Criteria - IATF 16949 Cl. 8.4.1.2 IATF 16949 - Automotive Quality Systems Standard 1
S What questions to ask in annual supplier evaluation? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Supplier Evaluation - Is a supplier score card a requirement under ISO and QSR? ISO 13485:2016 - Medical Device Quality Management Systems 7
a_bardi Excluding ISO9001 Cl. 8.4 - Supplier Selection and Evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Simple supplier evaluation qualification process form that includes Risk Assessment Document Control Systems, Procedures, Forms and Templates 2
S Supplier Evaluation - External Provider Evaluation (AS9100) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
Q Supplier evaluation for registrar? Registrars and Notified Bodies 2
E Supplier Evaluation Form - Example to evaluation suppliers (criteria) please Document Control Systems, Procedures, Forms and Templates 4
V Looking for a Supplier Evaluation template for Environmental Performance Miscellaneous Environmental Standards and EMS Related Discussions 1
D Can we exclude purchasing and supplier evaluation - ISO9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Crusader Service-Type Supplier Evaluation Exclusion? Supplier Quality Assurance and other Supplier Issues 12
N Supplier Evaluation - Simplest System Supplier Quality Assurance and other Supplier Issues 33
D Supplier Evaluation of a Finance Department Supplier Quality Assurance and other Supplier Issues 1
B Supplier Evaluation for ISO 9001 Clause 7.4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Is an Annual Supplier Evaluation an ISO 9001 requirement? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Clarification of ISO 9001 Clause 7.4.1 - Supplier Evaluation Supplier Quality Assurance and other Supplier Issues 13
Marc Definition ASES - Alliance Supplier Evaluation Standard Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
M ISO 13485 Calibration Supplier Evaluation Requirements question Other ISO and International Standards and European Regulations 2
L What to look for in a Vendor (Supplier) Evaluation for AVL ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Root Cause of 'Supplier Evaluation Not defined' Nonconformance and Corrective Action 15
L Supplier Selection and Evaluation - Raw Material Manufacturer vs. Distributor ISO 13485:2016 - Medical Device Quality Management Systems 3
A Supplier Evaluation SOP - How do I Define Major and Minor Suppliers? Supplier Quality Assurance and other Supplier Issues 14
S PPAP - Supplier Evaluation Responsibilities APQP and PPAP 1
V Supplier?s PPAP - Production Process Control Plan Review, Evaluation and Approval? FMEA and Control Plans 5
B EN 13980-2002 and EN 80079-34-2011 - 7.4.1.c) Supplier Evaluation Requirements Manufacturing and Related Processes 2
V ASES (Alliance Supplier Evaluation Standard) Check Sheet of Nissan wanted Customer and Company Specific Requirements 3
K Approved Vendor (Supplier) List and Supplier Evaluation Supplier Quality Assurance and other Supplier Issues 16
K Supplier Evaluation Form or Template wanted AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
D Supplier Evaluation Criteria and Supplier Re-evaluation Criteria Supplier Quality Assurance and other Supplier Issues 3
H ISO 13485 Sec 7.4 - Supplier Selection, Evaluation and Re-evaluation ISO 13485:2016 - Medical Device Quality Management Systems 20
A Supplier Evaluation Procedure in case of Agency (Distributors) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Do we need to conduct Vendor (Supplier) Evaluation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
K Fruit and Vegetable Supplier Evaluation wanted Food Safety - ISO 22000, HACCP (21 CFR 120) 9
Y Difference between Cl. 7.4.1 Supplier Re-Evaluation and Cl. 7.5.2 Revalidation Supplier Quality Assurance and other Supplier Issues 4
A Supplier Evaluation Responsibility Supplier Quality Assurance and other Supplier Issues 16
S Do we need to maintain Records of Internal Supplier Evaluation per 7.4.1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Moncia Supplier Re-Evaluation Process and Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I Do company sales agents/distributors need to go through supplier evaluation process? Other Medical Device and Orthopedic Related Topics 5
A Evaluation of Supplier & Evaluation of Outsourced Services different? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Supplier (Steel Mill supplying ingots) Evaluation form wanted Document Control Systems, Procedures, Forms and Templates 10
M Supplier Re-evaluation Methods ISO 13485:2016 - Medical Device Quality Management Systems 8
R Approved Vendor (Supplier) List contain Vendor Evaluation? Supplier Quality Assurance and other Supplier Issues 6
A Procedure for Supplier Selection and Performance Evaluation - Comprehensive Example Supplier Quality Assurance and other Supplier Issues 5
S Supplier Evaluation Procedure ISO 17020 Supplier Quality Assurance and other Supplier Issues 2
quality1 Initial Supplier Evaluation Method - 7.4.1 Purchasing Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Similar threads


















































Top Bottom