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Changes from Addendum 2 [June 2018] to API Spec Q1 [9th Edition, June 2013]
Document No. CMS/BPD/P-009 Rev. 00 Published On 12 Dec 2019
Author: Nilesh Mistry (Quality Assurance Specialist)

Introduction

On 8th June 2018, the American Petroleum Institute (API) published Addendum 2 to API Spec Q1 [9th Edition, June 2013]
with 1-year implementation deadline for API Monogram Licensees and the organisations certified to API Spec Q1.
Addendum 2 went into full effect on June 1, 2019. API Spec Q1 is the specification for Quality Management System
Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industries. Addendum 2 is the most
significant change to API Spec Q1 since the release of API Spec Q1: Ninth Edition in June 2013. Effective 1st June 2019,
the organizations those operate in compliance to or those which are certified to API Spec Q1 shall be able to
demonstrate full compliance to the Addendum 2 requirements.

This article describes the background behind this addendum, explains the changes introduced by the addendum,
provides clause by clause comparison of requirements, and provides guidelines for implementation to fulfil the
requirements of this addendum.

Background

Basically, the Bureau of Safety and Environmental Enforcement (BSSE) within the U. S. Department of the Interior have
been working to identify and address the recurring problems with product failures. The BSSE QC failure investigation
team performs forensic evaluation of these product failures and issues reports called the “QC-FIT Reports”. One of these
QC-FIT Reports described repetitive connector and bolt failures in safety critical equipment. They admit a number of
bolt failures in Blowout Preventors (BOPs), Risers and other subsea equipment. After a thorough review, BSSE concluded
that the primary cause of those failures was hydrogen induced stress corrosion cracking (SCC) due to hydrogen
embrittlement. These failures were caused by ineffective, faulty or improperly applied coatings. After digging a little
deeper, one of the key findings that emerge was that, although the primary supplier’s QMS fully complied with the API
Specification Q1 and the API certification programs, the controls over critical sub-tier suppliers were even not exercised
or were not effective. As a result, the QMS only qualified first tier level suppliers and not other critical suppliers of the
processes within the supply chain. So, it turns out that the QMS conforming to the requirements of API Spec Q1 prior to
Addendum 2 did not identify or provide effective controls over critical products or process throughout the supply chain.
Obviously, something needed to be done. So, based on the results of the evaluations, BSSE recommended that the
industry development improve quality management standard that addresses the controls over multiple tier suppliers.
And that is how we arrived to the Addendum 2 to API Q1 9th Edition.

Synopsis

API defines supply chain as, Suppliers and associated sub-supplier(s) required for product realization. This means your
suppliers and your suppliers’ suppliers that they use for your product realization. Most organizations only focus on the
first level of their supply chain, which are their direct suppliers, but don’t drill down to the second level of the supply
chain, your suppliers’ suppliers. Organizations must consider the first and second level of their supply chain. Your first
level supplier may be doing a great job, but the risk to the quality of what they provide you may be in the second level
supplier. Addendum 2 is focused on ensuring organizations have a strong supply chain by focusing on both levels of
the supply chain.

The overview of the introduced changes is as below:

a) Modifies requirements related to purchasing to extend controls over supply chain. Requires to extend
purchasing controls up to sub-suppliers. Focuses on Supply Chain – considering suppliers & associated sub-
suppliers.
b) Enhances focus & requires to establish additional controls on critical purchases and outsourcing.
c) Requires to consider “components” in addition to products & activities for applying purchasing controls.
d) Requires the purchasing procedure to define type & extent of controls applied to supply chain for critical
purchases.
e) Requires verification of type & extent of controls applied by the suppliers - internally & to their supply chain for
critical purchases during initial evaluation and/or re-evaluation.

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f) Requires to determine frequency of supplier re-evaluation.

g) Requires to have criteria for supplier re-evaluation for critical purchases same as criteria for initial evaluation.
[In earlier scenario, the criteria for re-evaluation of suppliers providing critical supply was down-gradable to the
criteria for supplier re-evaluation for non-critical purchases.
h) Requires to ensure that the supply chain conform to requirements for validation if the organization chooses to
outsource a process that requires validation.
i) Adds requirements in verification of critical purchases, to review documentation, to verify use of applicable
versions of the specified purchasing information, and to have a procedure stating requirements for testing
considering the risk associated with supplier product quality.
j) Adds coating & plating in processes requiring validation when identified as critical to product performance.
k) Limits the corrective actions & preventive actions up to the suppliers rather than entire supply chain.

Affected Processes

The Addendum 2 brings changes to the following sections of API Spec Q1 [9th Edition, June 2013]:

a) Section 3.1.22 : Definitions

b) Section 5.4.3 : Design and Development Outputs
c) Section 5.6.1.1 : Procedure for Purchasing Control
d) Section 5.6.1.2 : Initial Supplier Evaluation for Critical Purchases
e) Section 5.6.1.3 : Initial Supplier Evaluation for Non-critical Purchases
f) Section 5.6.1.4 : Supplier Re-evaluation
g) Section 5.6.1.6 : Outsourcing
h) Section 5.6.2 : Purchasing Information
i) Section 5.6.3 : Verification of Purchased Products or Activities
j) Section 5.7.1.5 : Validation of Processes for Production & Servicing
k) Section 5.11.2 : MOC Implementation
l) Section 6.4.2 : Corrective Actions
m) Section 6.4.3 : Preventive Actions

Considering the changes in above enlisted sections of API Spec Q1, the affected QMS processes are as below:

a) Design and Development

b) Purchasing Control
i. Supplier Evaluation
ii. Supplier Re-evaluation
iii. Outsourcing
iv. Purchasing Information
v. Verification of Purchased Products or Activities
c) Validation of Processes for Production & Servicing
d) Management of Change
e) Corrective Actions
f) Preventive Actions

Clause by Clause Comparison

Following is the clause by clause comparison between the requirements of API Spec Q1 [9th Edition], before the
addendum and, after the addendum, showing the changes in red text:

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Clause by Clause Comparison

Clause Requirement (Before Addendum 2) Requirement (After Addendum 2)

#
API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16) API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16), Addendum 2
(Jun’18)

3.1.22 - supply chain

Suppliers and associated sub-supplier(s) required for product realization.

5.4.3 Design and Development Outputs Design and Development Outputs

Outputs shall be documented to allow verification against the design and development Outputs shall be documented to allow verification against the design and development
input requirements. input requirements.
Outputs shall: Outputs shall:
a) meet the input requirements for design and development; a) meet the input requirements for design and development;
b) provide appropriate information for purchasing, production, and servicing; b) provide appropriate information for purchasing, production, and servicing;
c) identify or reference design acceptance criteria (DAC); c) identify or reference design acceptance criteria (DAC);
d) include identification of, or reference to, products and/or components deemed d) include identification of, or reference to, products, components and/or activities
critical to the design; deemed critical to the design;
e) include results of applicable calculations; and e) include results of applicable calculations; and
f) specify the characteristics of the product that are essential for its safe and f) specify the characteristics of the product that are essential for its safe and
proper use. proper use.
Records of design outputs shall be maintained (see 4.5). Records of design outputs shall be maintained (see 4.5).
NOTE Identification of criticality of products and/or components can be maintained NOTE Identification of criticality of products, components, and/or activities can be
outside of the design and development process. maintained outside of the design and development process.

5.6.1.1 Procedure – Purchasing Control Procedure – Purchasing Control

The organization shall maintain a documented procedure to ensure that purchased The organization shall maintain a documented procedure to ensure that purchased
products or outsourced activities conform to specified requirements. products, components or activities conform to specified requirements.
The procedure shall address: The procedure shall address:
a) determination of the criticality of the activities or products as they are applicable a) identification of critical products, components or activities;
to conformance to product or customer specifications;
b) initial evaluation and selection of suppliers based on their ability to supply
b) initial evaluation and selection of suppliers based on their ability to supply products, components or activities in accordance with the organization‘s
products or activities in accordance with the organization‘s requirements (see requirements (see 5.6.1.2 and 5.6.1.3);
5.6.1.2 and 5.6.1.3);
c) type and extent of control applied to the supply chain for critical products,
c) type and extent of control applied to the supplier based on the criticality of the components or activities;
product or activity;
NOTE Section 5.6.1.6 contains additional requirements for outsourced activities.

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Clause by Clause Comparison

Clause Requirement (Before Addendum 2) Requirement (After Addendum 2)

#
API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16) API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16), Addendum 2
(Jun’18)
d) criteria, scope, frequency, and methods for reassessment of suppliers; d) criteria, scope, frequency, and methods for reassessment of suppliers; and
e) maintaining a list of approved suppliers and scope of approval; and e) maintaining a list of approved suppliers and scope of approval.
f) type and extent of control to be applied to outsourced activities (see 5.6.1.6).

5.6.1.2 Initial Supplier Evaluation – Critical Purchases Initial Supplier Evaluation – Critical Purchases
For purchase of critical products, components or activities, the criteria for the initial For purchase of critical products, components or activities, the initial evaluation of
evaluation of suppliers by the organization shall be site-specific for each supplier and suppliers by the organization shall be site-specific for each supplier and shall include the
shall include the following: following:
a) verification that the supplier’s quality management system conforms to the a) verification that the supplier’s quality management system conforms to the
quality system requirements specified for suppliers by the organization; and quality system requirements specified for suppliers by the organization;
b) assessment of the supplier to ensure its capability to meet the organization’s b) verification of the type and extent of control applied by the supplier, internally
purchasing requirements by: and to their supply chain, in order to meet the organization’s requirements; and
i. performing an on-site evaluation of relevant activities, or c) assessment of the supplier to ensure its capability to meet the organization’s
specified requirements by one or more of the following:
ii. performing first article inspection to ensure conformance to stated
requirements, or i. performing an on-site evaluation of relevant activities, or
iii. identifying how the supplied product conforms to stated requirements ii. performing first article (see 3.1.11) inspection to ensure conformance to
when limited by proprietary, legal, and/or contractual arrangements. stated requirements, or
iii. identifying how the supplied product, component or activity conforms
to stated require
iv. ments when limited by proprietary, legal, and/or contractual
arrangements.

5.6.1.3 Initial Supplier Evaluation – Noncritical Purchases Initial Supplier Evaluation – Noncritical Purchases
For purchase of noncritical products, components, or activities that impact product For purchase of noncritical products, components, or activities that impact product
realization or the final product, the criteria for evaluation of suppliers by the organization realization or the final product, the criteria for evaluation of suppliers by the organization
shall meet the requirements of 5.6.1.2 or satisfy one or more of the following: shall meet the requirements of 5.6.1.2 or satisfy one or more of the following:
a) verification that the supplier’s quality management system conforms to the a) verification that the supplier’s quality management system conforms to the
quality system requirements specified for suppliers by the organization; or quality system requirements specified for suppliers by the organization; or
b) assessment of the supplier to meet the organization’s purchasing requirements; b) assessment of the supplier to meet the organization’s purchasing requirements;
or or
c) assessment of the product upon delivery or activity upon completion. c) assessment of the product or component upon delivery, or activity upon
completion.

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 Conformity Management Solutions
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Clause by Clause Comparison

Clause Requirement (Before Addendum 2) Requirement (After Addendum 2)

#
API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16) API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16), Addendum 2
(Jun’18)

5.6.1.4 Supplier Re-evaluation Supplier Re-evaluation

For re-evaluation of all suppliers (critical and noncritical), the requirements of 5.6.1.3 shall The organization shall determine the supplier re-evaluation frequency based on supplier
apply. risk and supplier quality performance.
For the re-evaluation of suppliers of critical products, components or activities, the
requirements of 5.6.1.2 shall apply.
For the re-evaluation of suppliers of noncritical products, components or activities, the
requirements of 5.6.1.3 shall apply.

5.6.1.6 Outsourcing Outsourcing

Where an organization chooses to outsource any activity within the scope of its quality Where an organization chooses to outsource any activity within the scope of its quality
management system, the organization shall ensure that all applicable elements of its management system, the organization shall ensure that all applicable elements of its
quality management system are satisfied and shall maintain responsibility for product quality management system are satisfied and shall maintain responsibility for product
conformance to specified requirements, including applicable API product specifications, conformance to specified requirements, including applicable API product specifications,
associated with product realization. associated with product realization.
Records of outsourced activities shall be maintained (see 4.5). Records of outsourced activities shall be maintained (see 4.5).
NOTE See 5.7.1.5 for requirements when a process requiring validation is outsourced
within the supply chain.

5.6.2 Purchasing Information Purchasing Information

The organization shall ensure the adequacy of specified purchasing information prior to The organization shall ensure the adequacy of specified purchasing information prior to
their communication to the supplier. Purchasing information provided to the supplier their communication to the supplier. Purchasing information provided to the supplier
shall be documented and adequately describe the product or activity to be purchased, shall be documented and adequately describe the product or activity to be purchased,
including acceptance criteria, and where appropriate: including acceptance criteria, and where appropriate:
a) requirements for approval of supplier’s procedures, processes, and equipment; a) requirements for approval of supplier’s procedures, processes, and equipment;
b) applicable version of specifications, drawings, process requirements, inspection b) applicable version of specifications, drawings, process requirements, inspection
instructions, traceability, and other relevant technical data; instructions, traceability, and other relevant technical data;
c) requirements for qualification of supplier’s personnel; and c) requirements for qualification of supplier’s personnel; and
d) quality management system requirements. d) quality management system requirements.
NOTE Applicable specifications may include or be derived from the customer, API
product specifications, design output, and/or industry standards.

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Clause by Clause Comparison

Clause Requirement (Before Addendum 2) Requirement (After Addendum 2)

#
API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16) API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16), Addendum 2
(Jun’18)

5.6.3 Verification of Purchased Products or Activities Verification of Purchased Products or Activities

The organization shall maintain a documented procedure for the verification or other The organization shall maintain a documented procedure defining the verification or
activities necessary for ensuring that purchased products or activities meet specified other activities necessary for ensuring that purchased products, components or activities
purchase requirements. meet specified purchase requirements.
Where the organization or its customer intends to perform verification at the supplier‘s For critical products, components or activities, the procedure shall include the following:
premises, the organization shall state the intended verification arrangements and a) review of the organization’s required documentation from the supplier; and
method of product release in the purchasing information.
b) verification that the applicable versions were used when specifications,
The organization shall ensure and provide evidence that purchased products and
drawings, process requirements, inspection instructions, traceability, and other
activities conform to specified requirements.
relevant technical data are specified per 5.6.2. b).
The organization shall maintain records of verification activities (see 4.5).
Additionally for critical products and components, the procedure shall include
requirements for the testing or inspection methods, frequency and responsible party for
these activities. The requirements shall be based on risk associated with supplier product
quality.
Where the organization or its customer intends to perform verification at the supplier‘s
premises, the organization shall state the intended verification arrangements and
method of product release in the purchasing information.
The organization shall ensure and provide evidence that purchased products and
activities conform to specified requirements.
The organization shall maintain records of verification activities (see 4.5).

5.7.1.5 Validation of Processes for Production & Servicing Validation of Processes for Production & Servicing
The organization shall validate processes for production and servicing where the resulting The organization shall validate processes for production and servicing where the resulting
output cannot be verified by subsequent monitoring or measurement, and as a output cannot be verified by subsequent monitoring or measurement, and as a
consequence, deficiencies become apparent only after the product is in use or the consequence, deficiencies become apparent only after the product is in use or the
servicing has been delivered. Validation shall demonstrate the ability of these processes servicing has been delivered. Validation shall demonstrate the ability of these processes
to achieve planned results. Where an organization chooses to outsource a process that to achieve planned results. Where an organization chooses to outsource a process that
requires validation, the organization shall require that the supplier conform to these requires validation, the organization shall require that the supply chain conform to these
requirements (see 5.6.1.6). requirements (see 5.6.1.6).
The organization shall maintain a documented procedure to address methods for review The organization shall maintain a documented procedure to address methods for review
and approval of the processes including: and approval of the processes including:
a) required equipment; a) required equipment;
b) qualification of personnel; b) qualification of personnel;

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 Conformity Management Solutions
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Clause by Clause Comparison

Clause Requirement (Before Addendum 2) Requirement (After Addendum 2)

#
API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16) API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16), Addendum 2
(Jun’18)
c) use of specific methods, including identified operating parameters; c) use of specific methods, including identified operating parameters;
d) identification of acceptance criteria; d) identification of acceptance criteria;
e) requirements for records (see 4.5); and e) requirements for records (see 4.5); and
f) revalidation. f) revalidation.
The organization shall validate those processes identified by the applicable product The organization shall validate those processes identified by the applicable product
specification as requiring validation. If these processes are not identified, or there is no specification as requiring validation. If these processes are not identified, or there is no
product specification involved, the processes requiring validation shall include, as a product specification involved, the processes requiring validation (if applicable to the
minimum, nondestructive examination, welding, and heat treating, if applicable to the product) shall include, as a minimum:
product.
a) nondestructive examination;
b) welding;
c) heat treating; and
d) coating and plating (when identified as critical to product performance by
product specification or the organization).

5.11.2 MOC Implementation MOC Implementation

The organization shall use the MOC process for any of the following that may negatively The organization shall use the MOC process for any of the following that may negatively
impact the quality of the product: impact the quality of the product:
a) changes in the organizational structure (see 4.2.2); a) changes in the organizational structure (see 4.2.2);
b) changes in key or essential personnel (see 4.3.2); b) changes in key or essential personnel (see 4.3.2);
c) changes in critical suppliers (see 5.6.1.1); and/or c) changes in suppliers of critical products, components or activities (see 5.6.1.1);
and/or
d) changes to the management system procedures, including changes resulting
from corrective and preventive actions (see 6.4). d) changes to the management system procedures, including changes resulting
from corrective and preventive actions (see 6.4).

6.4.2 Corrective Actions Corrective Actions

The organization shall maintain a documented procedure to correct nonconformities and The organization shall maintain a documented procedure to correct nonconformities and
to take corrective actions, both internally and within the supply chain, to eliminate the to take corrective actions, both internally and with suppliers, to eliminate the causes of
causes of nonconformities in order to minimize the likelihood of its recurrence. Corrective nonconformities in order to minimize the likelihood of its recurrence. Corrective actions
actions shall be appropriate to the effect(s) of the nonconformity encountered. shall be appropriate to the effect(s) of the nonconformity encountered.
NOTE Corrective action can apply to both quality management system processes and NOTE Corrective action can apply to both quality management system processes and
nonconforming product trends. nonconforming product trends.

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Clause by Clause Comparison

Clause Requirement (Before Addendum 2) Requirement (After Addendum 2)

#
API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16) API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16), Addendum 2
(Jun’18)
The procedure shall identify requirements for: The procedure shall identify requirements for:
a) reviewing a process nonconformity (including customer complaints); a) reviewing a process nonconformity (including customer complaints);
b) determining and implementing corrections; b) determining and implementing corrections;
c) identifying the root cause of the nonconformity and evaluating the need for c) identifying the root cause of the nonconformity and evaluating the need for
corrective actions; corrective actions;
d) implementing corrective action to reduce the likelihood that a nonconformity d) implementing corrective action to reduce the likelihood that a nonconformity
recurs; recurs;
e) identifying the timeframe and responsible person(s) for addressing corrections e) identifying the timeframe and responsible person(s) for addressing corrections
and corrective action; and corrective action;
f) verification of the effectiveness of the corrections and corrective action taken; f) verification of the effectiveness of the corrections and corrective action taken;
and and
g) MOC (see 5.11) when the corrective actions require new or changed controls g) MOC (see 5.11) when the corrective actions require new or changed controls
within the quality management system. within the quality management system.
Records of the activities for control of a nonconforming process shall be maintained (see Records of the activities for control of a nonconforming process shall be maintained (see
4.5). Records shall identify the activities performed to verify effectiveness of the corrective 4.5). Records shall identify the activities performed to verify effectiveness of the corrective
actions taken. actions taken.

6.4.3 Preventive Action Preventive Action

The organization shall maintain a documented procedure to determine and implement The organization shall maintain a documented procedure to determine and implement
preventive actions, both internally and within the supply chain, to eliminate the causes of preventive actions, both internally and with suppliers, to eliminate the causes of potential
potential nonconformities in order to minimize the likelihood of their occurrence. nonconformities in order to minimize the likelihood of their occurrence. Preventive
Preventive actions shall be appropriate to the effect(s) of the potential problems. actions shall be appropriate to the effect(s) of the potential problems.
NOTE Preventive action can apply to both quality management system processes and NOTE Preventive action can apply to both quality management system processes and
product analysis. product analysis.
The procedure shall identify requirements for: The procedure shall identify requirements for:
a) identifying opportunities for improvements; a) identifying opportunities for improvements;
b) identifying a potential nonconformity and its potential cause(s); b) identifying a potential nonconformity and its potential cause(s);
c) evaluating the need for preventive action, including any immediate or short- c) evaluating the need for preventive action, including any immediate or short-
term action required, to prevent occurrence of a nonconformity; term action required, to prevent occurrence of a nonconformity;
d) identifying the timeframe and responsible person(s) for implementing a d) identifying the timeframe and responsible person(s) for implementing a
preventive action; preventive action;

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 Conformity Management Solutions
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Clause by Clause Comparison

Clause Requirement (Before Addendum 2) Requirement (After Addendum 2)

#
API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16) API Q1 9th Edition, Errata (Feb’14), Errata 2 (Mar’14), Addendum 1 (Jun’16), Addendum 2
(Jun’18)
e) reviewing the effectiveness of the preventive action taken; and e) reviewing the effectiveness of the preventive action taken; and
f) MOC (see 5.11) when the preventive action require new or changed controls f) MOC (see 5.11) when the preventive action require new or changed controls
within the quality management system. within the quality management system.
Records of the activities for control of potential process nonconformities shall be Records of the activities for control of potential process nonconformities shall be
maintained (see 4.5). maintained (see 4.5).

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Implementation Guidelines & Required Actions

To implement the changes introduced by Addendum 2 and to demonstrate full compliance to this addendum, the
required actions are described below in a step-by-step manner:

1) Avail a copy of Addendum 2 and keep it along with specification set having API Spec Q1 [9th Edition, June 2013],
Errata 1 [February 2014], Errata 2 [March 2014], Addendum 1 [June 2016]. The Addendum 2 can be downloaded
from Techstreet.

A copy of API Spec Q1 [9th Edition, June 2013] with all the errata and addendums incorporated into it can be
downloaded from Techstreet.

2) Modify the registry of external origin documents to include Addendum 2.

3) Identify the changes affecting the processes of your Quality Management System.

4) Develop training content to impart awareness on the changes. Impart training to all the concerned personnel
engaged in the affected processes.

5) Modify following documented procedures to incorporate the changes introduced by the addendum:

a. Procedure for Design and Development

i. Include identification of activities which are deemed critical to the design along with products
and components.

b. Procedure for Supplier Evaluation and Re-evaluation

i. Identify the critical products, components or activities in the procedure;

ii. Include “components” for supplier evaluation and selection.

iii. Identify the type and extent of controls to be applied to sub-suppliers in addition to the
suppliers. Describe the types and extent of these controls for entire supply chain.

iv. In the criteria for initial evaluation of suppliers providing critical supplies, include criteria for
verification of type and extent of control applied by the supplier, internally and to their supply
chain.

v. Define re-evaluation frequency based on the supplier risk and supplier quality performance.

It is recommended to define the frequency in two situations – a) a standard frequency for re-
evaluation of suppliers, and b) a conditional frequency for re-evaluation of suppliers
considering the change in supplier risk and supplier quality performance.

The standard frequency for re-evaluation of suppliers providing critical purchases may be more
strict than that of suppliers providing non-critical purchases.

Quality Performance Assessment: Describe a methodology to determine supplier quality

performance. Define the frequency for this determination (This may be done half yearly or
annually). Establish an acceptance criteria for this evaluation. Identify the actions needed if
supplier fails to meet this criteria (Recommended Actions: Disqualification from List of
Approved Suppliers and a fresh Re-evaluation). If supplier meets this acceptance criteria, then
consider the standard frequency for re-evaluation.

Supplier Risk: Perform a supplier risk assessment considering the quality & delivery risks. Enlist
and prioritize the identified risks. Establish a condition based on the supplier risk which may
call for re-evaluation of the supplier. If there are no circumstance corresponding to the defined
condition, then consider the standard frequency for re-evaluation.

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c. Procedure for Outsourcing Control

i. Address the need for supply chain to conform to the requirements for validation of processes
when the process requiring validation is outsourced.

d. Procedure for Verification of Purchased Products, Components and Activities

i. Include “components” for verification of purchased supply.

ii. Include followings in verification of critical purchases:

1. Review of the organization’s required documentation from the supplier (e.g. test
report, material test certificates, inspection clearance / inspection release notes, etc).

2. Verify use of applicable versions of the specified purchasing information. (e.g.

verification of revision of purchase order referenced in the supplied material test
certificate, verification of the edition of applicable standard referenced in the supplied
test report against the edition specified in purchase order, etc).

3. Incoming control inspection & testing methods, frequency and responsibility

considering the risks associated with the supplier product quality.

e. Procedure for Validation of Processes for Production & Servicing

i. Address the applicability of the procedure to the supply chain when the process requiring
validation is outsourced.

ii. Include coating and plating in process requiring validation when identified as critical to
product performance by product specification or by the organization.

f. Procedure for Management of Change

i. Replace “critical suppliers” with “suppliers of critical products, components or activities”.

g. Procedure for Corrective Actions

i. Replace “supply chain” with “suppliers”. Limit the corrective actions up to the suppliers rather
than entire supply chain. [If feasible and necessary, the organization may continue the
application extended up to the supply chain as that is more stringent].

h. Procedure for Preventive Actions

i. Replace “supply chain” with “suppliers”. Limit the corrective actions up to the suppliers rather
than entire supply chain. [If feasible and necessary, the organization may continue the
application extended up to the supply chain as that is more stringent].

6) Modify Quality Manual to the address the changes in affected sections, and include the addendum in
references section of Quality Manual.

7) Impart training to the personnel concerned with the affected changes in the procedures and manual.

8) Start identifying the activities which are deemed critical to the design as Design and Development Outputs.

9) Perform re-evaluation of suppliers based on the revised procedure. Start performing initial evaluation of
suppliers based on the revised procedure.

10) When the process requiring validation is outsourced, ensure the process is validated as per the organization’s
documented procedure.

11) Start performing the verification of purchased supplies as per the revised procedure.

12) If coating and/or plating are/is required and these/this processes/process are/is identified as critical to product
performance by product specification or by the organization, ensure that the processes/process are/is validated
as per the organization’s documented procedure.

Doc. No. CMS/BPD/P-009 Rev.00 © Conformity Management Solutions. All Rights Reserved. Page 11 of 12
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13) Start taking corrective actions and preventive actions as per the revised procedures.

14) Cover the Addendum 2 requirements in Internal Audits. Verify the adequacy of revised procedures and manual
against the Addendum 2 requirements. Verify whether the personnel concerned with the affected changes are
trained for implementation of Addendum 2 or not. Verify the effectiveness of implementation of the revised
procedure and manual. Identify and report the gaps observed.

15) Consider the changes introduced by Addendum 2 as input in management review in agenda point “changes
that could affect the quality management system, including changes to legal and other applicable
requirements (such as industry standards)”. Report effectiveness of implementation of Addendum 2
requirements. Report the gaps observed in the implementation. Bring any relevant open actions in the notice
of top management.

Doc. No. CMS/BPD/P-009 Rev.00 © Conformity Management Solutions. All Rights Reserved. Page 12 of 12