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Internal Audit Process Report

API Q2, 1st Edition


Revision: 1
08/01/2016

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

QUALITY SYSTEM PROCESS AUDIT REPORT SUMMARY


DATE OF AUDIT:
SCOPE OF AUDIT:
SPECIFICATION /
SERVICE / SERVICERELATED PRODUCT
LOCATION OF AUDIT:
AUTHORITY:
PURPOSE:
AUDIT TEAM:
PRIMARY CONTACTS:
SUMMARY:

Reported by:

Q2 Audit Checklist

Date:

Page 2 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

INTERNAL AUDIT CHECKLIST / REPORT


API Spec Q2, 1st Edition
Process oriented report format
To be completed in its entirety for all IQAS LLC audits performed (unless otherwise indicated)

TABLE OF CONTENTS
Auditor Instructions................................................................................................................................... 4
Pre-Audit Activities......................................................................................................................... 5
Opening Meeting Details / Checklist........................................................7
Identification of QMS Processes........................................................................................................8
Quality Management System ...............................................................................................................9
Objectives
............................................................................................................................. 10
Communications
............................................................................................................................. 10
Management Responsibility.................................................................................................................... 11
Organizational Capability........................................................................................................................ 12
Documentation Requirements................................................................................................................. 13
Control of Records ............................................................................................................................. 15
Realization of Service & Service-Related Product..................................................................................15
Planning
............................................................................................................................. 16
Risk Assessment & Management............................................................................................................ 17
Design & Development........................................................................................................................... 17
Contingency Planning............................................................................................................................. 19
Purchasing
............................................................................................................................. 19
Control of Service Provision.................................................................................................................... 21
Service Quality Plan ............................................................................................................................. 22
Identification & Traceability..................................................................................................................... 23
Service Related Product Status.............................................................................................................. 23
Customer Property ............................................................................................................................. 23
Preservation of Service-Related Product................................................................................................24
Validation of Service-Related Product.....................................................................................................24
Preventive Maintenance, Measurement, Inspection & Test Plan.............................................................25
Control of Testing, Measuring, Monitoring & Detection Equipment..........................................................25
Service Performance Validation.............................................................................................................. 26
Control of Nonconformities...................................................................................................................... 27
Management of Change.......................................................................................................................... 28
Monitoring, Measuring & Improving.........................................................................................................29
Internal Audit
............................................................................................................................. 29
Analysis of Data
............................................................................................................................. 30
Improvement
............................................................................................................................. 31
Corrective Action
............................................................................................................................. 32
Preventive Action
............................................................................................................................. 32
Management Review ............................................................................................................................. 34
General Summary
............................................................................................................................. 35
Closing Meeting Details/Checklist........................................................................................................... 36
Nonconformity Summary Sheet.............................................................................................................. 37

Q2 Audit Checklist

Page 3 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

AUDITOR INSTRUCTIONS
I.

Please review and study this document in its entirety prior to commencing the audit. Ensure that that you have a full
understanding of all the requirements, the IQAS audit process and the IQAS audit documentation. If you have any questions or
comments please contact IQAS.

II.

The purpose of this document is to provide evidence of the conformity of an Applicant/Registered Organizations quality management
system with API Spec Q2 requirements. All sections must be completed for audits of organizations applying for or with Registrations to API
Spec Q2. When performing the audit:
A.

Use this document to record audit evidence that all areas of the management system meet applicable requirements. This includes
collecting and documenting objective evidence that the facility is meeting all applicable product specification requirements.

B.

Review relevant documents and procedures, as needed that control the area being audited.

C.

Document the audit evidence for each area being audited to verify implementation of requirements.

D.

Interview the people in the area who are actually doing the work, not just the management / supervisors who probably knows what to
do and what the requirements are.

E.

Select and document on this report at least three (3) samples of audit evidence for each area (where applicable) being audited to
verify implementation of requirements. If less than the required three (3) samples are available in the population, state the fact on the
applicable report page.

F.

If there is a nonconformity identified, the organization is to use the organizations Corrective Action Process. The organization is to
identify all applicable requirements therein, including the API Spec, organizations Quality Manual and procedures, etc.

III.

Record audit evidence observed in as much detail as possible and determine whether an activity is in conformity with specified requirements
or not. For any audit evidence to be considered by IQAS, it must be documented. This includes notations on observations and interviews
performed. Please use additional sheets if necessary.

IV.

The Auditor should direct the organization to address any nonconformity using the organizations corrective action process.

V.

The Auditor will review the following processes as classified by IQAS. There may be overlapping areas that may require repeat visits to the
appropriate working areas. Audit plans should allow for such overlapping occurrences:
Quality Management System Requirements
o
General
o
Quality Management System
o
Quality Policy
o
Objectives
o
Planning
o
Communications
o
Management Responsibility
o
Organization Structure
o
Responsibility and Authority
o
Organization Capability
o
Provisions of Resources
o
Human Resources
o
Work Environment
o
Documentation Requirements
o
General
o
Control of Documents
o
Control of Records

Quality Management System Measurement, Analysis, and


Improvement
o
General
o
Monitoring, Measuring and Improving
o
Customer Satisfaction
o
Internal Audit
o
Analysis of Data
o
Improvement
o
General
o
Corrective Action
o
Preventive Action
o
Management Review
o
General
o
Input Requirements
o
Output Requirements

Q2 Audit Checklist

Realization of Services and Service-Related Product


o
Contract Review
o
General
o
Determination of Requirements
o
Review of Requirements
o
Planning
o
Risk Assessment and Management
o
Design and Development
o
Design and Development Planning
o
Design and Development Inputs
o
Design and Development Outputs
o
Design and Development Verification
o
Design and Development Final Review and
Approval
o
Control of Design and Development Changes
o
Contingency Planning
o
General
o
Planning Output
o
Purchasing
o
Purchasing Control
o
Purchasing Information
o
Verification of Purchased Services and Servicerelated Product
o
Execution of Service
o
Control of Execution of Service
o
Service Quality Plan
o
Identification and Traceability
o
Servicerelated Product Status
o
Customer Property
o
Preservation of Service-related Product
o
Validation of Service-related Product
o
Preventive Maintenance, Inspection, and Test
Program
o
Control of Testing, Measuring, Monitoring, and Detection
Equipment
o
Service Performance Validation
o
Control of Nonconformities
o
General
o
Nonconforming Service Execution and Servicerelated Product
o
Verification and Documentation
o
Customer Notification
o
Management of Change
o
General
o
MOC Implementation
o
MOC Evaluation, Notification and Controls

Page 4 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

VI.

Confirmation of scope, QMS standards, auditor man-days and other instructions:

AUDITOR COMPLETE THE FOLLOWING ADDITIONAL ACTIONS:


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Verify API applicant uses current version of API Spec Q2


Verify API Spec Q2 scope of registration/compliance as
identified is to or continues to be applicable to the
organization
Verify effective implementation of corrective actions identified
during last:
Internal Audit
Other Audits (Customer Audits)
API Audit / APIQR Audit
Provide any comments with regards to the use of the current specifications / standards:

Please note that the auditor is not permitted to increase or decrease the number of audit days assigned
without explicit approval from IQAS Staff. Please contact IQAS for guidance. If approval to deviate from time
assigned, please provide a justification below, the name of the IQAS staff person issuing the approval, and date of the
approval:

IQAS Staff Name:

Date:

Inc / Dec Amount:

Verify the total number of employees (including part time, clerical, seasonal and contract)
working at the facility that fall under the API Spec Q2 Scope of Registration/Compliance
activities. Please note that any changes in the total number of personnel from the
original number identified in the audit assignment may require a change in the number
of auditor days. Please contact IQAS Staff for guidance:
Total # of
Employees

Q2 Audit Checklist

Page 5 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

OPENING MEETING DETAILS / CHECKLIST


Opening Meeting Date:
Start Time:
End Time:

OPENING MEETING CHECKLIST:


ITEM

Complete
(Y / N / NA)

1. Complete Attendance Sheet


2. Make introductions, including identification of roles in audit team, QMS, etc.
3. Review Audit Scope, Purpose, and Objectives
4. Review Audit Plan and Schedule
a. All changes must be documented in the plan
5. Review Confidentiality and Conflict of Interest Policy
6. Review break times and lunch arrangements
7. Request private room for use during audit as applicable
8. Determine and review safety requirements (Personal Protective Equipment (PPE)) and any facility
restrictions
9. Review audit sampling and audit methods
10. Confirm communication channels and language of the audit and reporting
11. Confirm roles of guides and escorts
12. Inform facility of when and why an audit may be stopped
a. Auditor safety in jeopardy
b. Acts of nature require stoppage
c.

Complete QMS failure

d. Serious violation of program requirements including conduct policy


13. Request briefing of Clients organization and status of the quality program
a. Identification and confirmation of QMS scope
b. Identification and confirmation of personnel
c.

Identification and confirmation of any changes (as applicable)

Additional comments as necessary:

Q2 Audit Checklist

Page 6 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

IDENTIFICATION OF QMS PROCESSES


The organization is required to identify all processes needed for the quality management system their application, sequence and interaction. If this has not
been completed a CAR must be documented.
The SERVICE REALIZATION PROCESSES must be described in specific detail to provide information regarding the capabilities of the facility
being audited. For example, service processes (activities that transfer inputs into outputs) must be identified clearly as provisions of resources and/or
service-related product, proper sequence/order in a service activity, monitoring and measuring the effectiveness of activities, and/or applying changes or
correction to activities.

DOCUMENT THE PROCESS INFORMATION IN THE TABLE BELOW:


Please note the table below is a tool for identifying the QMS and service realization processes. Flowcharts or other documents can be included
that clearly describe the QMS processes and their sequence and interaction. These alternative documents can be included with the report
instead of the information in the table below.
PROCESS NAME

SEQUENCE, INTERACTION AND PROCESS DESCRIPTION


PLEASE CLEARLY IDENTIFY THOSE PROCESSES THAT ARE
OUTSOURCED

PROCESS CONTROL INFORMATION


INCLUDING RESPONSIBILITY WITHIN
QMS

Quality Management System


Requirements
Management Responsibility
Organization Capability
Documentation Requirements
Control of Records
Realization of Service & ServiceRelated Product
Contract Review
Planning
Risk Assessment & Management
Design & Development
Contingency Planning
Purchasing
Execution of Service
Control of Testing, Measuring,
Monitoring & Detection Equipment
Service Performance Validation
Control of Nonconformities
Management of Change
Quality Management System
Measurement, Analysis and
Improvement
Monitoring, Measuring & Improving
Internal Audit
Analysis of Data
Improvement
Corrective Action
Preventive Action
Management Review

NOTE: Identify all service processes applicable to the scope of registration (use additional pages as required).

Q2 Audit Checklist

Page 7 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

QUALITY MANAGEMENT SYSTEM


Verify that the defined scope of registration and required documentation has been developed and maintained by the organization. Procedures and
control features (documented methods) shall be stand-alone documents and must be audited as each part of audit of the requirements / section in
question.
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Scope & Application Requirements (1/1.1)


Verify that the scope of registration is accurate for the
activities and processes performed by the facility.
Document any discrepancies.

Verify any Exclusions as applicable and justified (refer to


Sections 1.2 for guidance on allowable exclusions):

Verify service scope report any process & capability issues.

Additional comments/audit evidence regarding Scope & Application Requirement activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Normative References (2)


Verify that organization has included and considered
normative referances in the QMS implementation.
Additional comments/audit evidence regarding Normative References activities:

QUALITY MANAGEMENT SYSTEMS REQUIREMENTS

4.1

GENERAL
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Quality Management System (4.1.1)


Verify that the facility has established, documented,
implemented, maintained, measured the effectiveness of, and
improved their Quality Management System.
Does the QMS identify any legal and other applicable
requirements which the organization claims compliance and
are taken into account in its Quality Management System?
Additional comments/audit evidence regarding Quality Management System activities:

Q2 Audit Checklist

Page 8 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

CAR

COMMENTS/EVIDENCE:

Quality Policy (4.1.2)


Is the organizations policy for its commitment to quality:
a) Defined?
b) Documented?
c) Approved by top management?
d) The basis for the development of appropriate quality
objectives?
How is the organizations policy for its commitment to quality
communicated, understood, implemented, and maintained at
all relevant functions and levels of the organization?
Additional comments/audit evidence regarding Quality Policy activities:

REQUIREMENT:

Objectives (4.1.3)
Has management ensured that quality objectives, including
those needed to meet requirements for the service and
service-related product are established at relevant functions
and levels within the organization?
Are the quality objectives:
a)

Measureable?

b)

Consistent with the Quality Policy?

Additional comments/audit evidence regarding Objectives activities:

OBJECTIVE

FUNCTIONAL AREA

MEASUREMENT METHOD

IDENTIFY COMPONENT OF
THE QUALITY POLICY TO
WHICH OBJECTIVE IS
TIED

Additional comments/audit evidence regarding Objectives activities:

Q2 Audit Checklist

Page 9 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Planning (4.1.4)
How has management ensured that:
a) The planning of the quality management system is
carried out in order to meet the requirements of API
Q2?
b) The integrity of the quality management system is
maintained when changes to the QMS are planned
and implemented?
Additional comments/audit evidence regarding QMS Planning & Changes activities:

4.1.5

COMMUNICATIONS
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Internal (4.1.5.1)
How has management ensured
that appropriate
communication processes are established within the
organization and the effectiveness of the QMS is
communicated?
What processes has the organization established to ensure
that customer, legal, and other applicable requirements are
communicated at relevant levels?
What processes has the organization established for
ensuring the results of data analysis are communicated at
relevant levels? (see 6.3)
Additional comments/audit evidence regarding QMS Internal Communication activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

External (4.1.5.2)
Has the organization determined, documented, and
implemented the process for communicating with external
organizations to ensure requirements are fully understood
and risk is managed (see 5.3) throughout execution of
contract and execution of services including activities such
as:
a) Execution of inquiries, contracts, or order handling
and amendments (see 5.1);
b) Control of service and service- related product
information, including service-related nonconformities
(see 5.10);
c) Service quality plans and subsequent changes (see
5.7.2); and
d) Addressing feedback and complaints (see 6.2.1)?
Additional comments/audit evidence regarding External Communication activities:

Q2 Audit Checklist

Page 10 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

4.2

MANAGEMENT RESPONSIBILITY
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Organization Structure (4.2.1)


How has top management ensured the availability of
resources essential to establish, implement, maintain and
improve the QMS?
Note: Resources can include human resources and specialized
skills, organizational infrastructure, technology and financial
resources.

How has management provided evidence of its commitment


to the development and implementation of the QMS and
continual improvement of its effectiveness by:
a) Communicating to the organization the importance of
meeting customer as well as legal and or other
applicable requirements;
b) Ensuring that quality objectives are established
including key performance indicators (KPIs) for use in
data analysis; and
c) Conducting management reviews (see 6.5)?
Additional comments/audit evidence regarding Organization Structure activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Responsibility and Authority (4.2.2)


How are roles, responsibilities and authorities:

Defined,

Documented,

Assigned within, and

Communicated throughout the organization?

Has the organizations management appointed a specific


management representative(s) from within the organization
who has defined roles, responsibilities and authority for:
a)

Ensuring that the QMS is established, implemented and


maintained in accordance with the requirements of API
Spec Q2;

b)

Initiating actions(s) to minimize the likelihood of the


occurrence of nonconformities; and

c)

Reporting to management on the performance of the


QMS for review, including recommendations for
improvement.

Additional comments/audit evidence regarding Responsibility and Authority activities:

Q2 Audit Checklist

Page 11 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

4.3

ORGANIZATION CAPABILITY
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Provision of Resources (4.3.1)


Has the organization determined and provided the resources
needed to implement, maintain, and improve the
effectiveness of the QMS?
Additional comments/audit evidence regarding Provision of Resources activities:

4.3.2

HUMAN RESOURCES
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

General (4.3.2.1)
Record the documented procedure defining personnel
competency activities include revision level and approval
status
Has the organization maintained a documented procedure for
defining personnel competency within the organization and
identifying training requirements?
Does the procedure provide for the training of all personnel?
Does the procedure include provisions for ensuring the
effectiveness of the actions taken to achieve the necessary
competency of personnel?
Additional comments/audit evidence regarding Human Resources activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Personnel Competence (4.3.2.2)


Have personnel been deemed competent based on the
appropriate education, training, skills and experience needed
to meet service and service-related product requirements?
Are records maintained to show evidence of the
determination of competence of personnel?
Additional comments/audit evidence regarding Personnel Competence activities:

Q2 Audit Checklist

Page 12 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Training and Awareness (4.3.2.3)


Has the organization:
a) Provided for QMS training and for job training of the
its personnel and contractors who affect the execution
of services or provision of service-related products;
b)

Ensured that customer specified training and/or


customer-provided training, if required, is included in
the training program;

c)

Ensured that the frequency and content of training


complies
with
legal
and
other
applicable
requirements;
Ensured that its personnel are aware of the relevance
and importance of their activities and how they
contribute to the achievement of the quality
objectives;
Identified and provided training on legal and other
applicable requirements; and

d)

e)
f)

Maintained appropriate records of education, training


skills and experience (see 4.5).

Additional comments/audit evidence regarding Training and Awareness activities:

COMPLETE THE FOLLOWING USING PERSONNEL INTERVIEWED THROUGHOUT THE AUDIT (YES/NO RESPONSE ACCEPTABLE):
SELECT REPRESENTATIVE SAMPLING OF PERSONNEL PERFORMING WORK AFFECTING QUALITY.
PERSON / POSITION

COMPETENCE REQUIREMENTS
DETERMINED /
VERIFIED AS
IDENTIFIED
COMPETENT

INDIVIDUALS
AWARE OF THEIR
ROLES IN THE QMS

CURRENT
RECORDS EXIST

Additional comments/audit evidence regarding Responsibility and Authority activities:

Q2 Audit Checklist

Page 13 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Work Environment (4.3.3)


Has the organization determined, provided, managed, and
maintained the work environment needed to achieve
conformity to applicable service or service-related product
requirements?
Work environment includes, as applicable:
a)

Buildings, workspace, and associated utilities;

b)

Process equipment (both hardware and software);

c)

Supporting services (such as transport


communication or information systems); and

d)

Conditions under which work is performed


including physical, environmental, and other
factors.

or

Additional comments/audit evidence regarding Work Environment activities:

4.4

DOCUMENTATION REQUIREMENTS
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

General (4.4.1)
Does the QMS documentation include:
a) Statements of quality policy and quality objectives;
b)

A quality manual that addresses each requirement of


API Spec Q2 and included the following:
1) The scope of the QMS;
2) Description of the interaction between the
processes of the QMS, including the reference to
documented procedures;
3) Allowable exclusions and the basis for claiming
those exclusions (see 1.2); and
4) Identification of legal and other applicable
requirements to which the organization claims
compliance;
c) Documented procedures established for the QMS;
and
d) Documents to ensure the effective planning, operation
and control of its processes, and conformance to
specified requirements?
Are procedures required by API Spec Q2 and the QMS
established, documented, implemented and maintained?
NOTE: A single document can address the requirements for one or
more procedures. A requirement for documented procedures can
be covered by more than one document.
Additional comments/audit evidence regarding Documentation Requirements activities:

Q2 Audit Checklist

Page 14 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Control of Documents (4.4.2)


Identify the documented procedure for Control of Documents
activities include revision level and approval status.
Does the procedure define the controls needed to:
a) Ensure that documents required by the QMS,
including revisions, translations, and updates, are
reviewed and approved for adequacy prior to issue
and use;
b) Define responsibilities for approval and re-approval of
documents;
c) Identify changes to the documents;
d)

Ensure that documents remain legible and readily


identifiable; and
e) Ensure relevant versions of applicable documents are
available where the activity is being performed?
Are obsolete documents removed from all points of issue or
use, or otherwise identified to prevent unintended use if they
are retained for any purpose?
Is there a master list or equivalent established to identify the
current revision status of documents?
Additional comments/audit evidence regarding Control of Document activities:

4.5

CONTROL OF RECORDS
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Control of Records (4.5)


Identify the documented procedure for Control of Records
activities include revision level and approval status.
Does the documented procedure define the controls and
responsibilities needed for the:

Initiation,

Identification,

Collection,

Storage,

Protection,

Retrieval,

Retention time, and

Disposition of records?

How does the organization control records from outsourced


activities to provide evidence of conformity to requirements
and of the effective operation of the quality management
system?
Have records been established and controlled to provide
evidence of conformity to requirements and of the effective
operation of the QMS?
Are records:

Legible?
Q2 Audit Checklist

Page 15 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT:

CAR

Identifiable?

Readily retrievable?

Retained for a minimum of five years or as required by


customer, legal and other applicable requirements,
whichever is longer?

COMMENTS/EVIDENCE:

Additional comments/audit evidence regarding Control of Records activities:

5
5.1

REALIZATION OF SERVICE AND SERVICE-RELATED PRODUCT


CONTRACT REVIEW
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

General (5.1.1)
Identify the documented procedure for the review of
requirements related to the execution of services or provision of
service-related products.
Additional comments/audit evidence regarding Contract Review activities:

DOCUMENT / CONTRACT REVIEWED


1
2
3
4
5
Additional comments/audit evidence regarding Document / Contract Review activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Determination of Requirements (5.1.2)


Has the organization determined:
a) Requirements specified by the customer, including
the requirements for service planning, execution, and
evaluation);
b) Legal and other applicable requirements; and
c)

Requirements not stated by the customer but


considered necessary by the organization for the
execution of service and provision of service-related
products?

Q2 Audit Checklist

Page 16 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Where the customer provides no documented statement of the


requirements, are the customer requirements confirmed by the
organization and records maintained (see 4.5)
Additional comments/audit evidence regarding Determination of Requirements activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Review of Requirements (5.1.3)


Does the organization review of the requirements related to
the execution of the service or provision of service-related
products?
Is the review being conducted prior to the organizations
commitment to provide a service to the customer, and does it
ensure that:
a) Requirements are defined
b)

Requirements differing from those previously are


identified and resolved;
c) The organization has the capability to meet the
defined requirements.
When contract requirements are changed, is the organization
ensuring that relevant documents are amended and that
relevant personnel are made aware of the changed
requirements?
Are records of the results of the review, including resulting
actions maintained (see 4.5)?
Additional comments/audit evidence regarding Review of Requirements activities:

5.2

PLANNING
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Does the organization identify and plan the processes and


documents needed for service and service-related product
realization?
In planning, has the organization addressed the following:
a)

Customer-specified requirements, including critical


success factors;

b)

Key performance indicators;

c)

Legal and other applicable requirements;

d)

Initial risk assessment (see 5.3);

e)

Required
resources
management (see 4.3);

f)

Service and/or service-related product design ( see


5.4);

g)

Contingency planning ( see 5.5);

h)

Management of change (see 5.11); and

Q2 Audit Checklist

and

work

environment

Page 17 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT:

i)

CAR

COMMENTS/EVIDENCE:

Records needed to provide evidence that the


realization processes meet requirements (see 4.5)?

Additional comments/audit evidence regarding Planning activities:

5.3

RISK ASSESSMENT AND MANAGEMENT


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Identify the procedure for risk assessment and management


include revision level and approval status.
Does the procedure:
a)

Identify risks (potential or real) associated with


services and service-related products;

b)

Identify and use risk management tools and


techniques;

c)

Select, communicate and implement the mitigation


or preventive control measures to reduce or avoid
exposure to loss; and

d)

Notify the customer of remaining risks that may


impact the service?

Verify that records of risk assessment and actions taken are


maintained ( see 4.5).
Additional comments/audit evidence regarding Risk Assessment and Management activities:

5.4

DESIGN AND DEVELOPMENT


SERVICE DESIGN & DEVELOPMENT MATRIX

Select a representative sampling (minimum of three) of the applicable services.


PRODUCT NAME

API SPECIFICATION

1
2
3
4
5
6

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Design and Development Planning (5.4.1)


Identify the procedure for planning and controlling the design
and development of the service, including the use of servicerelated products include revision level and approval status.
Does the procedure identify:
a) The design and development stages;
b)

The activities required for completion, review, and


verification of each stage:

Q2 Audit Checklist

Page 18 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

c)

The interfaces between different groups involved in


design and development activities; and
d) The responsibilities and authorities for the design and
development activities?
When design and development are outsourced, does the
organization ensure the supplier meets the requirements of 5.4
and provide objective that the supplier has met their
requirements.
Additional comments/audit evidence regarding Design and Development Planning activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Design and Development Inputs (5.4.2)


Are Inputs relating to design of the service determined and
records maintained (see 4.5)?
Do these inputs include:
a)

Customer-specified requirements (see 5.1);

b)

Legal requirements; and

c)

Other applicable requirements including:


1)

Requirements
source;

provided

from

any

external

2)

3)

Requirements for service-related products,


including
its
functional
and
technical
requirements;
Environmental and operational conditions;

4)

Results from risk assessments (see 5.3); and

5)

Historical performance and other information


derived from pervious similar service designs?

Additional comments/audit evidence regarding Design and Development Input activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Design and Development Outputs (5.4.3)


The outputs of design and development shall be documented
to allow verification against the design and development input
requirements.
Do the design and development outputs:
a)

Meet the input


development;

b)

Provide information for purchasing of any required


service-related product;

c)

Provide controls for the execution of the service,


including allowable variations in the service execution
parameters;
Include or reference acceptance criteria for the
completion of the service); and

d)

Q2 Audit Checklist

requirements

for

design

and

Page 19 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT:

e)

CAR

COMMENTS/EVIDENCE:

Identify critical service-related product?

Additional comments/audit evidence regarding Design and Development Output activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Design and Development Verification (5.4.4)


Is the verification of the design of the service performed in
accordance with planned arrangements (see 5.4.1) to ensure
that the design and development outputs have met the
design and development input requirements.
Are records of the results of the design and development
verification maintained? (see 4.5)
Additional comments/audit evidence regarding Design and Development Verification activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Design and Development Final Review and Approval


(5.4.5)
Is a final design and development review conducted and
documented?
Have individual(s) other that the person or persons who
developed the design reviewed and approved the final design
and development outputs?
Are records of the results of the final review and approval
maintained?
Additional comments/audit evidence regarding Design and Development Final Review and Approval activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Control of Design and Development Changes (5.4.6)


Are changes in the approved design reviewed and verified by
the management of change process? (see 5.11)
Additional comments/audit evidence regarding Control of Design and Development Changes activities:

Q2 Audit Checklist

Page 20 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

5.5

CONTINGENCY PLANNING
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

General (5.5.1)
Identify the documented procedure for Contingency Planning
activities include revision level and approval status.
Does the procedure include incident and disruption
prevention and mitigation measures?
Is contingency planning integrated into services and
supporting processes between the organization, its suppliers
and the customer?
Additional comments/audit evidence regarding Contingency Planning General activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Planning Output (5.5.2)


Is contingency planning output documented and
communicated to the relevant operational personnel, and
updated as required to minimize the likelihood or duration or
disruption of execution of service.
Is the contingency plan being based on assessed risks (see
5.3)?
Does the Contingency Plan include, at a minimum:
a)
b)
c)
d)

Actions required in response to significant risk


scenarios;
Actions required to mitigate the effects of disruptive
incidents: and;
Identification and assignment of responsibilities
and authorities: and
Internal and external communications controls?

Additional comments/audit evidence regarding Contingency Planning activities:

Q2 Audit Checklist

Page 21 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

5.6

PURCHASING
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Purchasing Control (5.6.1)


Identify the documented procedure for purchasing activities
that ensure that purchased or outsourced services and
service-related products conform to specified requirements
include revision level and approval status.
Does the purchasing procedure address:
a)

The determination of the criticality of the services


and/or service-related products obtained;
b)
The evaluation and selection of suppliers based on
their ability to supply services and service-related
products in accordance with the organizations
requirements;
c)
The type and extent of control applied to the supplier
and service and/or service-related product based on the
criticality of the service and service-related product;
d)
Criteria, scope, frequency, and methods used when
performing an assessment on a supplier; and
e)
Maintaining a list of approved suppliers and scope
of approval.?
For critical services or service-related product, is the criteria
for the initial evaluation and selection of suppliers by the
organization include the following prior to initiation of the
purchase agreement:
1)
Assessment of the supplier at the suppliers facility
to meet the organizations purchasing requirements;
and
2)
Verification that the suppliers QMS conforms to the
quality system requirements specified for suppliers by
the organization?
For re-evaluation of suppliers and the initial evaluation of
suppliers for non-critical services or service-related product by
the organization, one or more of the following shall apply
(indicate which is applicable):
i.
Assessment of the supplier to meet the organizations
purchasing requirements;
ii.
Verification that the suppliers QMS conforms to the
QMS requirements specified for suppliers by the
organization;
iii.
Assessment of the supplier upon delivery of the
product or service.
Are records of the results of assessments and any necessary
actions arising from the evaluation maintained (see 4.5)?
Where supplier assessment results in the need for corrective
actions, is evidence of effective implementation of such
actions maintained in accordance with 6.4.2?
Additional comments/audit evidence regarding Purchasing Control activities:

Q2 Audit Checklist

Page 22 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

DOCUMENT / PURCHASE ORDER

SUPPLIER

DATE

1.
2.
3.
4.
5.
6.
Complete table for the suppliers selected and identified above. Identify product name and Yes (Y) / No (N) / Not Applicable (NA) for each column.
All No identifiers shall require a CAR to be raised and details provided therein. Use additional pages if required.
REQUIREMENT

SAMPLE SELECTED (REFERENCED ABOVE)


3
4
5
6

CAR

Have criteria for selection/evaluation been defined?


Have criteria for re-evaluation of suppliers been defined?
Have evaluations been performed and results maintained?
Supplier records maintained?
Additional comments/audit evidence regarding Purchasing Control activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Purchasing Information (5.6.2)


Is the purchasing information provided to the supplier
documented and does it describe the services or servicerelated product to be purchased, including where appropriate:
a)
Requirements for acceptance criteria of service
and service-related products;
b)

Requirements
for
approval
of
procedures, processes, and equipment;

c)

The applicable version of specifications, drawings,


process requirements, inspection instructions, and
other relevant technical data;

d)

Requirements
personnel, and

e)

for

qualification

of

suppliers

suppliers

QMS requirements.

Additional comments/audit evidence regarding Purchasing Information activities:

Q2 Audit Checklist

Page 23 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Verification of Purchased Services and Service-Related


Product (5.6.3)
Identify the documented procedure for the verification or
other activities necessary for ensuring that purchased service
and service-related product meets specified purchased
requirements include revision level and approval status.
Have records for verification activities been maintained? (see
4.5)
Does the organization ensure and provide evidence that
outsourced services and service-related products conform to
specified requirements?
Additional comments/audit evidence regarding Verification of Purchased Services and Service-Related Product activities:

DOCUMENT / PURCHASE ORDER


1.
2.
3.
4.
5.
6.
Complete table for the suppliers selected and identified above. Identify Yes (Y) / No (N) / Not Applicable (N/A) for each column.
All No identifiers shall require a CAR to be raised and details provide therein. Use additional pages if required.
REQUIREMENT

SAMPLE SELECTED (REFERENCED ABOVE)

CAR

Have criteria for verification of service and/or service related product been defined?
Have criteria for verification of service and/or service related product been met
Have verification of service and/or service related product records been maintained?
Additional comments/audit evidence regarding Verification of Purchasing Information activities:

Q2 Audit Checklist

Page 24 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

5.7

Execution of Service
5.7.1 Control of Service Provision
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

General (5.7.1.1)
Identify the documented procedure that describes the
integration of the following as a minimum, into the
development of a service quality plan. Include revision level
and approved status.
a) Personnel training and competence (see 4.3.2);
b)

Defined contract requirements (see 5.1);

c)

Risk assessment and management (see 5.3);

d)

Information that describes the characteristics of the


service and service-related products and ensuring
design requirements are satisfied (see 5.4); and

e)

Identification of equipment, including required testing,


measuring, monitoring, and detection devices (see
5.8).

Additional comments/audit evidence regarding Control of Service Provision Information activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

CAR

COMMENTS/EVIDENCE

Documentation (5.7.1.2)
Are controls for execution of the service documented in
routings, travelers, checklists, process sheets, or other types
of documents? Explain.
Does the documentation include requirements for verifying
conformity to quality plans, procedures, and applicable
standards/codes?
Do the documents include or reference instructions,
workmanship, and acceptance criteria for processes, tests,
inspections, and customer inspection hold or witness points?
Additional comments/audit evidence regarding Documentation activities:

5.7.2

Service Quality Plan


REQUIREMENT

General (5.7.2.1)
Has the organization developed a service plan that controls the
execution of services or use of service-related products?
Additional comments/audit evidence regarding Service Quality Plan activities:

Q2 Audit Checklist

Page 25 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT

CAR

COMMENTS/EVIDENCE

Plan Content (5.7.2.2)


Does the service quality plan address each of the following:
a) Required activities and documentation for compliance
with customer and legal requirements;
b) Identification of responsible functions for each activity,
including external parties;
c)

Identification and reference to control of subcontractors;

d)

e)

Identification of the relevant revision for each procedure,


specification, or other document referenced or used in
each activity;
Identification of the requirements to perform acceptance
inspection of each activity, including hold, witness,
monitor and document review points for representatives
of the organization and the customer;

f)

Service equipment and monitoring devices; (see 5.8)

g)

Identification and controls of risk;(see 5.3)

h)

Identification of critical services and service-related


products;

i)

Identification of the required deliverables; and

j)

Identification of the required records. (see 4.5)

Is the service quality plan updated when any of the plan content
changes?
Additional comments/audit evidence regarding Service Quality Plan Information activities:

REQUIREMENT

CAR

COMMENTS/EVIDENCE

Plan Approval (5.7.2.3)


Are service quality plans and any revisions to them documented
and approved by the organization?
When required by contract, is/are the service quality plan(s) and
any revisions communicated to the customer?
Additional comments/audit evidence regarding Service Quality Plan Information activities:

Q2 Audit Checklist

Page 26 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

5.7.3

IDENTIFICATION AND TRACEABILITY


REQUIREMENT

CAR

COMMENTS/EVIDENCE

Identify the documented procedure for identification and


traceability service-related product include revision level
and approval status.
Does the procedure include identification controls at all
stages of as required by the organization and the customer
for:

Delivery;

Installation;

Repair; and

Redress?

Does the procedure include requirements for maintenance or


replacement of identification and traceability marks, and
records?
How is service-related product identified?
Is critical service-related product identified and traceable to
preventive maintenance, inspection, and test program
(PMITP) records (see 4.5 and 5.7.8) and the original
manufacture?
Additional comments/audit evidence regarding Identification and Traceability Information activities:

5.7.4

SERVICE-RELATED PRODUCT STATUS


REQUIREMENT

CAR

COMMENTS/EVIDENCE

Identify the documented procedure for the identification of


service-related product status include revision level and
approval status.
Additional comments/audit evidence regarding Service-Related Product Status Information activities:

5.7.5

CUSTOMER PROPERTY
REQUIREMENT

CAR

COMMENTS/EVIDENCE

Identify the documented procedure for customer property


activities include revision level and approval status.
Does the documented procedure specify the protection of
customer property while under control of the organization,
including:

Identification,

Verification,

Storage,

Preservation,

Maintenance, and

Q2 Audit Checklist

Page 27 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT

CAR

COMMENTS/EVIDENCE

Protection of customer property

Does customer property include customer-derived intellectual


property and customer-specific data?
Does control of customer property include reporting to the
customer any loss, damage or unsuitable use of customersupplied property?
Does the organization identify, verify, protect, and safeguard
customer property provided for use in the service and/or
service-related product?
Are records maintained for the control and disposition of
customer supplied property (See 4.5)?
Additional comments/audit evidence regarding Customer Property Information activities:

5.7.6

PRESERVATION OF SERVICE-RELATED PRODUCT


REQUIREMENT

CAR

COMMENTS/EVIDENCE

Identify the documented procedure for preservation of


service-related product include revision level and approval
status.
Does the documented procedure describe the methods used to
preserve the service-related product during internal processing
through execution of service?
Describe the controls and processes established and
implemented for preservation (as applicable) to:

Identification

Traceability

Transportation

Handling

Packaging

Storage

Protection

Does preservation also apply to the constituent parts of the


service-related product?
In order to detect deterioration, is the condition of the servicerelated product or constituent parts in stock assessed at
intervals specified in the procedure?
Additional comments/audit evidence regarding Preservation of Service-Related Product Information activities:

Q2 Audit Checklist

Page 28 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

5.7.7

VALIDATION OF SERVICE-RELATED PRODUCT


REQUIREMENT

CAR

COMMENTS/EVIDENCE

Is validation of the service-related product completed prior the


execution of the service?
Are records of the results of validation, when performed,
maintained (see 4.5).
Additional comments/audit evidence regarding Validation of Service-related Product Information activities:

5.7.8

PREVENTIVE MAINTENANCE, INSPECTION, & TEST PROGRAM


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Identify the procedure for Preventive Maintenance, Inspection,


and Test Program include revision level and approval status.
Does the procedure address:

Record keeping requirements (see 4.5);

Inspection;

Maintenance;

Redress;

Repair;

Make-up;

Testing; and

Acceptance criteria for the service-related product?

As a minimum, does the PMITP include:


a)

Actions which address preventive maintenance;

b)

Reports that document usage history, repairs or redress,


modifications, remanufacturing, inspection, and test
activities that allow direct verification for reuse of
product;
c) List of critical spare parts requirements by the customer
and/or technical requirements including those
recommended by the original equipment manufacturer;
and
d) Controls that ensure equipment integrity to original
performance requirements and design acceptance
criteria are maintained?
If original performance requirements cannot me met, is the
MOC process used continued use?
NOTE 2: The PMITP can be based on risk, system reliability, usage history,
experience, industrial recommended practices, relevant codes and standards,
original equipment manufacturing guidelines, or other applicable requirements.

Additional comments/audit evidence regarding Preventive Maintenance, Inspection, and Test Program activities:

Q2 Audit Checklist

Page 29 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

5.8

CONTROL OF TESTING, MEASURING, MONITORING, & DETECTION


EQUIPMENT
REQUIREMENT

CAR

COMMENTS/EVIDENCE

Identify the documented procedure(s) for the control of testing,


measuring, monitoring, and detection equipment include revision
level and approval status.
How has the organization determined the required testing,
measuring, monitoring, and detection equipment to be controlled and
necessary to provide evidence that service or service-related product
meets specified requirements?
Verify that the procedure addresses:

Equipment traceability;

Frequency of calibration;

Calibration method;

Acceptance criteria; and

Suitable environmental conditions

Verify that testing, measuring, monitoring, and detection equipment:


a) Is calibrated or verified, or both, at specified intervals, or prior
to use, against measurement standards traceable to
international or national measurement standards; or where no
such standards exist, the basis used for calibration or
verification is recorded,
b) Have identification in order to determine its calibration status,
c)

Is safeguarded from adjustments that would invalidate the


measurement result, and

d)

Is protected from damage and deterioration during handling,


maintenance and storage?

When used in the testing, measurement, monitoring and detection of


specified requirements, is the ability of computer software to satisfy
the intended application confirmed?
Is this confirmation undertaken prior to initial use and reconfirmed as
necessary?
When the equipment is externally provided, does the organization
verify that the equipment is suitable to provide evidence of conformity
of service or service-related product to specified requirements?
Does the organization maintain a registry of the required testing,
measurement, monitoring and detection equipment that includes an
unambiguous form of identification, specific to each piece of
equipment?
Are records of the results of calibration and verification maintained?
Additional comments/audit evidence regarding Control of Testing, Measuring, Monitoring, and Detection Equipment activities:

Q2 Audit Checklist

Page 30 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

NOTES ON RECORDS:
1. All records must be legible, retrievable, identifiable and protected from damage / deterioration (API Spec Q2).

2. Records retention must be verified by sampling records that have been retained for the minimum retention times required by API Spec Q2 (5 yrs.) or by the applicable industry / customer
requirements.
Complete the following using Testing, Measuring, Monitoring, and Detection Equipment reviewed during the audit:
CAL
EQUIPMENT TYPE
SERIAL NO.
CAL. DATE
ACCURACY
FREQUENCY

CALIBRATION
STATUS

NIST*

ANSWER YES / NO
STORED
SAFEGUARD

If no national / international reference is available, ensure that the basis for traceability for calibration has been established
Additional comments/audit evidence regarding Control of Testing, Measuring, Monitoring, and Detection Equipment activities:

5.9

SERVICE PERFORMANCE VALIDATION


REQUIREMENT

CAR

COMMENTS/EVIDENCE

Identify the documented procedure(s) for service


performance validation include revision level and approval
status.
Does the organization validate processes at appropriate
stages during the execution of the service in accordance with
design requirements (see 5.4) and the service quality plan
(see 5.7.2)?
Is evidence of conformity with established acceptance
criteria, including KPIs and critical success factors
maintained?
Comment on how service performance validation records are
maintained, including identification of the person(s) accepting
the results (see 4.5).
Additional comments/audit evidence regarding Service Performance Validation activities:

5.10

CONTROL OF NONCONFORMITIES
REQUIREMENT

CAR

COMMENTS/EVIDENCE

General (5.10.1)
Identify the documented procedure(s) for control of
nonconformities- include revision level and approval status.
Does the procedure define the controls and related
responsibilities and authorities for addressing nonconforming
service execution and service-related product?
Is the level of response proportionate to the severity of the
nonconformity and its effect on the execution of service?
Additional comments/audit evidence regarding Control of Nonconformities activities:

Q2 Audit Checklist

Page 31 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

REQUIREMENT

CAR

COMMENTS/EVIDENCE

Nonconforming Service Execution and Service-Related


Product (5.10.2)
Does the organization address nonconforming service
execution or service-related product by the following
sequence of activities:
a) Taking action to correct the nonconformity; or
b) When 5.10.2 a) is not possible or appropriate, by
taking action to preclude the use of service-related
product from its intended use or application; or
c) When 5.10.2 a) and 5.10.2.b) are not appropriate, by
authorizing release or acceptance under concession
by a relevant authority and/or the customer?
For nonconforming service execution, does the organization
take corrective action in accordance with 6.4.2 that is
appropriate to the effects, or potential effects, of the
nonconformity?
Additional comments/audit evidence regarding Nonconforming Service Execution and Service-Related Product activities:

REQUIREMENT

CAR

COMMENTS/EVIDENCE

Verification and Documentation (5.10.3)


What controls are used to ensure that corrected nonconforming
services or service-related product is re-verified to demonstrate
conformity to the requirements?
Are records of the nature of nonconformities and any
subsequent actions taken, including concessions obtained,
and maintained?
Additional comments/audit evidence regarding Verification and Documentation activities:

REQUIREMENT

CAR

COMMENTS/EVIDENCE

Customer Notification (5.10.4)


What is the process for notifying customers in the event that
the service execution does not conform to service design
requirements or when nonconforming service-related product
has been delivered or used in the execution of the service?
Verify process controls and that customer notification records
exist.
Additional comments/audit evidence regarding Customer Notification activities:

Q2 Audit Checklist

Page 32 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


Complete the following using nonconformity report records:
NCR #

NONCONFORMANCE

DISPOSITION
ACTION

ACTION TO ELIMINATE NONCONFORMITY

RE-VERIFIED

REPORT DATE

Additional comments/audit evidence regarding Nonconformity Report Records activities:

5.11

MANAGEMENT OF CHANGE
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

General (5.11.1)
Identify the procedure (s) for Management of Change (MOC)
include revision level and approval status.
Has the organization identified the potential risks associated
with the change and any required approvals prior to the
introduction of such changes?
Additional comments/audit evidence regarding Management of Change activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

MOC Implementation (5.11.2)


Has the organization used the MOC process for any of the
following that may impact the execution of service:
a) Changes or proposed changes in the organizational
structure;
b) Changes in key personnel, whose absence or
departure could negatively impact the service;
c) Changes in critical supplier whose absence or
departure could negatively impact the service;
d) Changes in the management system procedures,
including temporary changes and improvements
resulting from corrective and preventive actions;
e) Changes to original equipment manufacturers
specifications, applications, and/or software for
service-related product;
f)
Changes in approved design (see 5.4) including those
that were originally agreed upon by the customer and
those required by changes in legal and other
applicable requirements?
Additional comments/audit evidence regarding Management of Change activities:

Q2 Audit Checklist

Page 33 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

MOC Evaluation, Notification and Controls (5.11.3)


Does or has the organization conduct a risk assessment (see
5.3) when evaluating a potential change?
Does the organization notify relevant personnel, including the
customer, of the change and residual or new risk due to
changes that have either been initiated by the organization or
requested by the customer?
How does the organization ensure that relevant documents
are amended?
Is the organization maintaining records (see 4.5) of MOC
activities?
Additional comments/audit evidence regarding Management of Change activities:

6 QMS MEASUREMENT, ANALYSIS, AND IMPROVEMENT


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

General (6.1)
Has the organization planned and implemented the monitoring,
measurement, analysis, and improvement processes needed to
ensure conformity to, and continually improve the effectiveness
of the QMS?
Does the quality management system measurement,
analysis, and improvement include determination of
applicable methods, including techniques for the analysis of
data, and the extent of their use?
Additional comments/audit evidence regarding Management of Change activities:

6.2

MONITORING, MEASURING AND IMPROVING


REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Customer Satisfaction (6.2.1)


Identify the procedure(s) for monitoring customer
satisfaction include revision level and approval status.
Verify that the procedure addresses

customer feedback,

key performance indicators (KPIs), and

other information that the organization monitors to


determine whether the organization has met customer
requirements
Have records of results of customer satisfaction information
been maintained (see 4.5)?
Additional comments/audit evidence regarding Customer Satisfaction activities:

Q2 Audit Checklist

Page 34 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

6.2.2

INTERNAL AUDIT
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

CAR

COMMENTS/EVIDENCE:

General (6.2.2.1)
Identify the procedure(s) for planning and conducting internal
audits include revision level and approval status.
Does the planning of internal audits take into consideration
the results of previous audits and criticality of the process?
Describe how the organization defines the audit criteria,
scope, frequency, and methods used to ensure that all
elements of the QMS claiming conformity are audited at least
annually.
Identify the date of the last internal audit of the management
system was completed.
Verify that outsourced suppliers that impact the quality of
services or service-related product, located at the
organizations facility, are included as part of the internal audit
of the organization.
Additional comments/audit evidence regarding Internal Audit activities:

REQUIREMENT:

Performance of Internal Audits (6.2.2.2)


Does the organization conduct internal audits to determine
whether the QMS conforms to the requirements of API Q2
and is effectively implemented and maintained?
Are internal audits performed by competent personnel?
Are they independent of those who performed or directly
supervised the activity being audited?
Has an audit of all elements of the management system been
audited prior to claiming conformance to the requirements of
Q2?
Additional comments/audit evidence regarding Performance of Internal Audit activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Audit Review and Closure (6.2.2.3)


How does the organization identify response times for
addressing detected nonconformities?
Does the management responsible for the area being audited
ensure that any necessary corrections and corrective actions
are taken to eliminate detected nonconformities and their
causes?
Are there follow-up activities that include the verification of
the actions taken (see 6.4.2)?
Are records of the audits and their results maintained (see
4.5)?
Additional comments/audit evidence regarding Internal Audit Review and Closure activities:

Q2 Audit Checklist

Page 35 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

Comment on the effective implementation of audits performed on the QMS based on the following:

Auditor Qualification and Competence:

CAR (Y/N)

Methodologies and Normative References used


including API Spec requirements as applicable:

CAR (Y/N)

Audit Planning (Scope, Frequency, Importance, Results of Previous Audits):


CAR (Y/N)

Roles and Responsibilities to Perform Audits (Auditors do not audit their


own work):
CAR (Y/N)

Nonconformities Identified (Number, Type, Detail):

Effective Follow-up to Nonconformities:

CAR (Y/N)

CAR (Y/N)

Additional comments/audit evidence regarding Internal Audit activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Analysis of Data (6.3)


Identify the procedure(s) for analysis of data include
revision level and approval status.
Does the procedure identify and describe the use of the
techniques for the analysis of data?
To what extent has the organization determined, collected
and analyzed appropriate data to demonstrate the suitability
and effectiveness of the QMS, and evaluated where continual
improvement of the effectiveness of the QMS can be made?
Does the Analysis of Data include data generated as a result
of monitoring and measurement and from other sources?
Has the analysis of data provided information relating to:

Customer satisfaction (see 6.2.1);

Conformity to service design requirements ( see


5.4);
Characteristics and trends of processes and
service-related products including opportunities for
preventive actions ( see 6.4.1 and 6.4.3);
Supplier performance (see 5.6); and

Quality objectives (see 4.1.3)

Additional comments/audit evidence regarding Analysis of Data activities:

Q2 Audit Checklist

Page 36 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

6.4

IMPROVEMENT
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

General (6.4.1)
Identify the procedure(s) for methods used to monitor, evaluate
and improve the effectiveness and implementation of the QMS
processes for the execution of the service and use of servicerelated product include revision level and approval status.
Does the procedure identify how the organization uses the
following for the continual improvement of the effectiveness of the
QMS:

Quality policy;

Quality objectives;

Customer feedback;

Audit results;

Analysis of data;

Corrective and Preventative actions; and

Management review?

Additional comments/audit evidence regarding Improvement activities:

6.4.2

CORRECTIVE ACTION
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

[Action taken on nonconforming activity, i.e., the nonconformity has already


occurred]

Identify the procedure(s) for corrective action include


revision level and approval status.
What actions are taken by the organization to correct
nonconformities and to take corrective actions, both internally
and within the supply chain, to eliminate the cause of
nonconformities in order to minimize the likelihood of their
recurrence?
Does the procedure define the requirements for:
a)

Reviewing nonconformities
complaints;

(including

customer

b)

Identifying the root cause of the nonconformity and


implementing corrections;

c)

Evaluating the need for corrective actions to reduce


the likelihood that nonconformities reoccur;

d)

Identifying the timeframe and responsible person(s)


for making corrections and taking corrective action;

e)

Reviewing and ensuring the effectiveness of the


corrections and corrective action taken; and

f)

Maintaining records of the corrections and corrective


actions taken (see 4.5)

When the corrective action identifies the need for new or


changed controls, does the procedure require that the MOC
process (see 5.11) be applied to the proposed action?

Q2 Audit Checklist

Page 37 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

Review Records Complete the following for Corrective Actions raised internally during the previous 12-month period (Identify CAR for those activities that fail to meet
the requirements of the applicable standard, either from table below or as indicated in the previous two sections):
CAR#

DATE:

NONCONFORMITY:

ACTION TAKEN:

DATE VERIFIED

Additional comments/audit evidence regarding Corrective Action activities:

6.4.3

PREVENTIVE ACTION
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

[Action taken to minimize the likelihood of occurrence of a nonconforming


activity, i.e., the nonconformity has not yet occurred]

Identify the procedure(s) for preventive action include revision


level and approval status.
What actions are taken by the organization to determine and
implement preventive actions, both internally and within the supply
chain, to eliminate the causes of potential nonconformities in order
to minimize the likelihood of their occurrence?
Does the procedure define requirements for:
a)
Identifying potential nonconformities and their potential
causes;
b)
Evaluating the need for preventive action, including any
immediate or short term action required, to prevent
occurrence of nonconformities;
c)
Identifying the timeframe and responsible person(s) for
implementing preventive action;
d)
Reviewing the effectiveness of the preventive action
taken; and
e)
Maintaining records of results of preventive action taken
(see 4.5)
When the preventive action identifies the need for new or changed
controls, does the procedure require that the MOC process (see
5.11) be applied to the proposed action?
Review Records Complete the following for Preventive Actions raised during the previous 12-month period:
PAR#
DATE:
POTENTIAL NONCONFORMITY:
ACTION TAKEN:

DATE VERIFIED

Additional comments/audit evidence regarding Preventive Action activities:

Q2 Audit Checklist

Page 38 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

6.5

MANAGEMENT REVIEW
REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

General (6.5.1)
Identify date(s) of the management reviews that have
occurred within the last 12-month period:
NOTE: Ensure review of QMS by Top Management

Has the management review been documented with sufficient


evidence to evaluate the QMSs continuing suitability,
adequacy and effectiveness?
Does this review include assessing opportunities for
improvement and the need for changes to the QMS, including
the quality policy and quality objectives?
If no, note deficiencies.

Additional comments/audit evidence regarding Management Review activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Input Requirements (6.5.2)


Does the input to management review include, but not
limited to:
a)
Effectiveness of actions resulting from previous
management reviews;
b)

Results of internal audits ( see 6.2.2);

c)

Changes, including legal and other


requirements, that could affect the QMS;

d)

Customer feedback (see 6.2.1);

e)

Process effectiveness, including the results of risk


assessment (see 5.3);

f)

Status of corrective and preventive actions (see 6.4.2


and 6.4.3); and

g)

Review and analysis of failures in service and/or


service-related products (see 6.3).

applicable

Additional comments/audit evidence regarding Input Requirements activities:

REQUIREMENT:

CAR

COMMENTS/EVIDENCE:

Output Requirements (6.5.3)


Does the output from the management review include a
summary assessment of the status of the QMS?
Does the assessment include any required changes to the
processes and any decisions and actions, required
resources, and improvement of service and service-related
products in meeting customer requirements?
Has top management reviewed and approved the output of
management reviews?
Have records of management reviews been documented and
maintained?
Additional comments/audit evidence regarding Output Requirements activities:

Q2 Audit Checklist

Page 39 of 43

20550 Townsen Blvd, Suite 2105


Humble TX 77338
PH: 832-644-1743 / FX: 832-777-6098

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):

GENERAL SUMMARY
EFFECTIVENESS OF THE QUALITY MANAGEMENT SYSTEM
The following sections must be completed at the end of the audit process. The auditor is required to provide comments on
the overall implementation of the QMS, as well as provide additional insight into the operation of the QMS as elicited
through the following questions. All responses should be justified with audit evidence gathered during the audit. It is
acceptable to reference previously documented audit evidence (either as positive or negative findings). However,
reference to this evidence should not be considered an adequate substitute alone for the additional comments required.
Please be comprehensive in your responses and use additional pages if required.
General Requirements
Provide a summary of the extent to which the organization has
established and maintained a quality management system,
according to the requirements of which are described in API
Spec Q2.
Comment on how the processes needed for the QMS have
been identified and implemented and applied throughout the
organization.
In particular, identify apparent deficiencies.
How effectively has the organization determined the sequence
of the processes?

How effectively has the organization determined the criteria and


methods needed to ensure that both the operation and control
of the organizations processes are effective?
How effectively has the organization ensured the availability of
resources and information necessary to support the operation
and monitoring of its processes?
How effectively does the organization monitor, measure where
applicable, and analyze its processes?

How effectively has the organization implemented actions


necessary to achieve planned results and continually improve
its processes?
Additional comments / audit evidence regarding positive / negative aspects of the QMS (including opportunities for improvement, etc.):

Q2 Audit Checklist

Page 40 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

CLOSING MEETING DETAILS / CHECKLIST


Closing Meeting Date:
Start Time:
End Time:

CLOSING MEETING CHECKLIST:


ITEM

Complete (Y / N / NA)

1. Complete Attendance Sheet


2. Summarize audit activities
a. Discuss any areas not audited and why these areas were not audited
3. Review audit nonconformities and concerns
4. Review audit report comments
5. Discuss QMS effectiveness, positives, and areas for improvement
a. Internal audit and management review effectiveness
b. Positive observations
c.

Areas / opportunities for improvements

6. Final confirmation of scope of assessments, audits and/or registration


7. Discuss audit team recommendation
8. Inform client of the right to appeal any audit findings, nonconformities, and the recommendation
9. Confirm required changes (as applicable) to facility contact information
10. Review confidentiality and conflict of interest policy
11. Leave copies of CARs with the facility
Additional comments as necessary:

Q2 Audit Checklist

Page 41 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

AUDIT NONCONFORMITY/CONCERN SUMMARY SHEET


CAR #

Q2 Audit Checklist

PG #

N/C

CLASSIFICATION
Concern
QMS Ref

SUMMARY (AREA)
Spec Ref

Page 42 of 43

CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:

20550 Townsen Blvd, Suite 2105


Humble TX 77338

AUDIT DATE(s):

PH: 832-644-1743 / FX: 832-777-6098

AUDIT SUMMARY
FINAL AUDITOR/AUDIT TEAM REMARKS:

COMMENTS BY ORGANIZATIONS REPRESENTATIVE:

I (we) attest that the foregoing information is accurate and has been collected by the audit team during the
performance of an audit that was assigned to me (us) by IQAS LLC

Audit Team Leader

Date

Audit Team Member

Date

Audit Team Member

Date

By signing this document, it is not an admission of the acceptance of any nonconformities/concerns identified by the audit team. The
signature only confirms that the audit was performed and that a copy of the audit report was left with the facility. IQAS LLC reserves
the right to have final determination of the level of nonconformity identified in this audit report.

Management Representative of Audited Organization

Date

END OF REPORT

Q2 Audit Checklist

Page 43 of 43