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
o Supplier Evaluation
o Supplier Re-evaluation
o Outsourcing
o Purchasing Information
o 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

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 is available in the Full
Article.

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:
o Procedure for Design and Development
 Include identification of activities which are deemed critical to the design
along with products and components.
o Procedure for Supplier Evaluation and Re-evaluation
 Identify the critical products, components or activities in the procedure;
 Include “components” for supplier evaluation and selection.
 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.
 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.
 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.
o Procedure for Outsourcing Control
 Address the need for supply chain to conform to the requirements for
validation of processes when the process requiring validation is
outsourced.
o Procedure for Verification of Purchased Products, Components and Activities
 Include “components” for verification of purchased supply.
 Include followings in verification of critical purchases:
  Review of the organization’s required documentation from the supplier
(e.g. test report, material test certificates, inspection clearance / inspection
release notes, etc).
 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).
 Incoming control inspection & testing methods, frequency and
responsibility considering the risks associated with the supplier
product quality.
o Procedure for Validation of Processes for Production & Servicing
 Address the applicability of the procedure to the supply chain when the
process requiring validation is outsourced.
 Include coating and plating in process requiring validation when identified
as critical to product performance by product specification or by the
organization.
o Procedure for Management of Change
 Replace “critical suppliers” with “suppliers of critical products,
components or activities”.
o Procedure for Corrective Actions
 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].
o Procedure for Preventive Actions
 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.
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.

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