5.6.1.2 Initial Supplier Evaluation—Critical Purchases

R

rana.vijay114

Registered
Dear All,

Requirement:
As per API Q1 - Section 5.6.1.2 (b) -
verification of the type and extent of control applied by the supplier, internally and to their supply chain, in order to meet the organization’s requirements;

How can we demonstrate supplier's internal controls and their supply chain without auditing the supplier. Mostly, suppliers are not sharing their internal control and their supply chain process since they consider that those are classified details for their business.

Regards,
Vijay Rana
 
J

Jim R

Registered
Asking for their quality metrics and conformance to those metrics is not asking for proprietary information. Providing that information should not be an option. It should be a requirement to do business with you.

I know that there are cases where there are no alternative suppliers, but you should not let them hold you hostage - especially if they are certified.

Next, check your purchasing contract to see if that information is a requirement. If it is not, shame on your purchasing department.
 
J

jmech

Trusted Information Resource
Jim R said:
Asking for their quality metrics and conformance to those metrics is not asking for proprietary information. Providing that information should not be an option. It should be a requirement to do business with you.

I know that there are cases where there are no alternative suppliers, but you should not let them hold you hostage - especially if they are certified.

Next, check your purchasing contract to see if that information is a requirement. If it is not, shame on your purchasing department.
Click to expand...
This approach is based on the (often false) assumption that the purchaser has the power force the supplier to provide this information.

There are more flexible ways to approach this. What are your organization's requirements for controls applied by the supplier?
 
R

rana.vijay114

Registered
Jim R said:
Asking for their quality metrics and conformance to those metrics is not asking for proprietary information. Providing that information should not be an option. It should be a requirement to do business with you.

I know that there are cases where there are no alternative suppliers, but you should not let them hold you hostage - especially if they are certified.

Next, check your purchasing contract to see if that information is a requirement. If it is not, shame on your purchasing department.
Click to expand...

Thanks for your feedback
 
R

rana.vijay114

Registered
jmech said:
This approach is based on the (often false) assumption that the purchaser has the power force the supplier to provide this information.

There are more flexible ways to approach this. What are your organization's requirements for controls applied by the supplier?
Click to expand...

Fully agree with you. I already created alternative way to verify supplier's internal control. Thanks !!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J API Q1 - 5.6.1.2 (b) - Initial Supplier Evaluation—Critical Purchases Oil and Gas Industry Standards and Regulations 1
J Critical Supplier Initial evaluation for single purchases Oil and Gas Industry Standards and Regulations 16
A API Q1 5.6.1.2 - Initial Supplier Evaluation Oil and Gas Industry Standards and Regulations 16
Q Initial Supplier Evaluation Method - 7.4.1 Purchasing Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
dubrizo Initial Supplier Identification, Review and Controls ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Initial Supplier Audits In Person or Not? Federal Aviation Administration (FAA) Standards and Requirements 4
D Is it required to have the operator initial their work in the IATF 16949:2016 standard? IATF 16949 - Automotive Quality Systems Standard 3
A Establishing an initial audit schedule for Pharma Suppliers General Auditing Discussions 2
S Initial Audit FDA US Medical Device Regulations 3
D Initial Importer question Other US Medical Device Regulations 2
Y Must Initial importers have any QMS? US Food and Drug Administration (FDA) 1
M How to apply IEC 62304 Problem Resolution Process for bugs discovered prior to release i.e. during initial development? IEC 62304 - Medical Device Software Life Cycle Processes 2
S Initial PFMEA FMEA and Control Plans 6
M MDSAP required for Device Initial Importer/Distributor into Canada? Other Medical Device Regulations World-Wide 11
M Initial Importer/Distributor and Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 1
J Stage 2 audit initial cert, few data points ISO 13485:2016 - Medical Device Quality Management Systems 4
K Initial capability studies on similar parts APQP and PPAP 7
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
J Furnace repaired - Do I need a new initial TUS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
I IQOQ or just initial calibration required? General Measurement Device and Calibration Topics 3
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 4
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
H CQI-15 2nd Edition - Date of initial assessment? IATF 16949 - Automotive Quality Systems Standard 3
MrTetris How to qualitatively assess initial probability ISO 14971 - Medical Device Risk Management 4
S Private Label Requirements, Manufacturer's Registration & Initial Importers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Medical Device Initial Importer (DII) Requirements - Delivery Address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J AIAG PPAP: 2.2.11.3 Acceptance Criteria for Initial Study (page 9, 4th edition) APQP and PPAP 1
L Why is initial production units, lots, or batches, or their equivalents required for Design Validation? US Food and Drug Administration (FDA) 3
S Initial Importer and ISO 13485 (MDSAP) - Will the US company be included? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Should an Initial Importer separately do Establishment Registration? US Food and Drug Administration (FDA) 1
Y Time gap for First Surveillance Audit of AS9100D after initial certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
J Initial capability for injection molding part Capability, Accuracy and Stability - Processes, Machines, etc. 6
T Customer special status and initial IATF certification IATF 16949 - Automotive Quality Systems Standard 12
A Setting initial Expiry Date of an IVD per BS EN 23640:2015 Other Medical Device Related Standards 12
S Registration/Listing; Initial Importer - Private Label w/ Foreign Establishment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
V Inspection of Initial Importer/ Distributor Products and Materials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
GURU SDI Cleanliness Requirements for Initial Samples Customer Complaints 4
dubrizo Initial Impressions of Newly Released IATF 16949 Standard IATF 16949 - Automotive Quality Systems Standard 43
C Service and maintenance in an initial importer facility USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A We passed our ISO TS 16949 initial certification Covegratulations 3
knightarmourus Initial Samples with dimensional deviation in Serial Production Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
E Addition of Label by Initial Importer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Struggling with definition of Initial Importer and First Title 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W AS9100C registration - How long does the system have to run before initial audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
J Required Audit Days for TS 16949 Initial Certification Audit IATF 16949 - Automotive Quality Systems Standard 1
J Is DCR (Document Change Request) Needed for Initial QMS Procedures? Document Control Systems, Procedures, Forms and Templates 16
4 Initial Environmental Review and Gap Analysis, difference? Miscellaneous Environmental Standards and EMS Related Discussions 8
C DCN or ECN for Initial Release of FMEA & CP and subsequent changes? FMEA and Control Plans 3

Similar threads

Top Bottom