Professional Documents
Culture Documents
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
Reported by:
Q2 Audit Checklist
Date:
Page 2 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
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:
AUDIT DATE(s):
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
Q2 Audit Checklist
Page 4 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
VI.
CAR
COMMENTS/EVIDENCE:
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:
Date:
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:
AUDIT DATE(s):
Complete
(Y / N / NA)
Q2 Audit Checklist
Page 6 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
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:
AUDIT DATE(s):
CAR
COMMENTS/EVIDENCE:
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
4.1
GENERAL
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Q2 Audit Checklist
Page 8 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
CAR
COMMENTS/EVIDENCE:
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)
OBJECTIVE
FUNCTIONAL AREA
MEASUREMENT METHOD
IDENTIFY COMPONENT OF
THE QUALITY POLICY TO
WHICH OBJECTIVE IS
TIED
Q2 Audit Checklist
Page 9 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
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
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CITY, STATE, ZIP
PH:
AUDIT DATE(s):
4.2
MANAGEMENT RESPONSIBILITY
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Defined,
Documented,
b)
c)
Q2 Audit Checklist
Page 11 of 43
CLIENT
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AUDIT DATE(s):
4.3
ORGANIZATION CAPABILITY
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
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:
Q2 Audit Checklist
Page 12 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
c)
d)
e)
f)
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
Q2 Audit Checklist
Page 13 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
CAR
COMMENTS/EVIDENCE:
b)
c)
d)
or
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)
Q2 Audit Checklist
Page 14 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
4.5
CONTROL OF RECORDS
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Initiation,
Identification,
Collection,
Storage,
Protection,
Retrieval,
Disposition of records?
Legible?
Q2 Audit Checklist
Page 15 of 43
CLIENT
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AUDIT DATE(s):
CAR
Identifiable?
Readily retrievable?
COMMENTS/EVIDENCE:
5
5.1
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:
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Q2 Audit Checklist
Page 16 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
CAR
COMMENTS/EVIDENCE:
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
5.2
PLANNING
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
b)
c)
d)
e)
Required
resources
management (see 4.3);
f)
g)
h)
Q2 Audit Checklist
and
work
environment
Page 17 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
i)
CAR
COMMENTS/EVIDENCE:
5.3
CAR
COMMENTS/EVIDENCE:
b)
c)
d)
5.4
API SPECIFICATION
1
2
3
4
5
6
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Q2 Audit Checklist
Page 18 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
CAR
COMMENTS/EVIDENCE:
c)
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
b)
c)
Requirements
source;
provided
from
any
external
2)
3)
4)
5)
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
b)
c)
d)
Q2 Audit Checklist
requirements
for
design
and
Page 19 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
e)
CAR
COMMENTS/EVIDENCE:
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Q2 Audit Checklist
Page 20 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
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:
Q2 Audit Checklist
Page 21 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
5.6
PURCHASING
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Q2 Audit Checklist
Page 22 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
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
CAR
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Requirements
for
approval
of
procedures, processes, and equipment;
c)
d)
Requirements
personnel, and
e)
for
qualification
of
suppliers
suppliers
QMS requirements.
Q2 Audit Checklist
Page 23 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
CAR
COMMENTS/EVIDENCE:
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
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CITY, STATE, ZIP
PH:
AUDIT DATE(s):
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)
c)
d)
e)
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
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:
AUDIT DATE(s):
CAR
COMMENTS/EVIDENCE
d)
e)
f)
g)
h)
i)
j)
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
Q2 Audit Checklist
Page 26 of 43
CLIENT
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AUDIT DATE(s):
5.7.3
CAR
COMMENTS/EVIDENCE
Delivery;
Installation;
Repair; and
Redress?
5.7.4
CAR
COMMENTS/EVIDENCE
5.7.5
CUSTOMER PROPERTY
REQUIREMENT
CAR
COMMENTS/EVIDENCE
Identification,
Verification,
Storage,
Preservation,
Maintenance, and
Q2 Audit Checklist
Page 27 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
CAR
COMMENTS/EVIDENCE
5.7.6
CAR
COMMENTS/EVIDENCE
Identification
Traceability
Transportation
Handling
Packaging
Storage
Protection
Q2 Audit Checklist
Page 28 of 43
CLIENT
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CITY, STATE, ZIP
PH:
AUDIT DATE(s):
5.7.7
CAR
COMMENTS/EVIDENCE
5.7.8
CAR
COMMENTS/EVIDENCE:
Inspection;
Maintenance;
Redress;
Repair;
Make-up;
Testing; and
b)
Additional comments/audit evidence regarding Preventive Maintenance, Inspection, and Test Program activities:
Q2 Audit Checklist
Page 29 of 43
CLIENT
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AUDIT DATE(s):
5.8
CAR
COMMENTS/EVIDENCE
Equipment traceability;
Frequency of calibration;
Calibration method;
d)
Q2 Audit Checklist
Page 30 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
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
CAR
COMMENTS/EVIDENCE
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:
AUDIT DATE(s):
REQUIREMENT
CAR
COMMENTS/EVIDENCE
REQUIREMENT
CAR
COMMENTS/EVIDENCE
REQUIREMENT
CAR
COMMENTS/EVIDENCE
Q2 Audit Checklist
Page 32 of 43
CLIENT
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AUDIT DATE(s):
NONCONFORMANCE
DISPOSITION
ACTION
RE-VERIFIED
REPORT DATE
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:
Q2 Audit Checklist
Page 33 of 43
CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
CAR
COMMENTS/EVIDENCE:
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
CAR
COMMENTS/EVIDENCE:
customer feedback,
Q2 Audit Checklist
Page 34 of 43
CLIENT
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AUDIT DATE(s):
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:
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Q2 Audit Checklist
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CLIENT
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AUDIT DATE(s):
Comment on the effective implementation of audits performed on the QMS based on the following:
CAR (Y/N)
CAR (Y/N)
CAR (Y/N)
CAR (Y/N)
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Q2 Audit Checklist
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AUDIT DATE(s):
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;
Management review?
6.4.2
CORRECTIVE ACTION
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Reviewing nonconformities
complaints;
(including
customer
b)
c)
d)
e)
f)
Q2 Audit Checklist
Page 37 of 43
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AUDIT DATE(s):
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
6.4.3
PREVENTIVE ACTION
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
DATE VERIFIED
Q2 Audit Checklist
Page 38 of 43
CLIENT
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CITY, STATE, ZIP
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AUDIT DATE(s):
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
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
c)
d)
e)
f)
g)
applicable
REQUIREMENT:
CAR
COMMENTS/EVIDENCE:
Q2 Audit Checklist
Page 39 of 43
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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?
Q2 Audit Checklist
Page 40 of 43
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CITY, STATE, ZIP
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AUDIT DATE(s):
Complete (Y / N / NA)
Q2 Audit Checklist
Page 41 of 43
CLIENT
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AUDIT DATE(s):
Q2 Audit Checklist
PG #
N/C
CLASSIFICATION
Concern
QMS Ref
SUMMARY (AREA)
Spec Ref
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CLIENT
STREET ADDRESS
CITY, STATE, ZIP
PH:
AUDIT DATE(s):
AUDIT SUMMARY
FINAL AUDITOR/AUDIT TEAM REMARKS:
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
Date
Date
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.
Date
END OF REPORT
Q2 Audit Checklist
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