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API Q2 - Audit Checklist
API Q2 - Audit Checklist
API Q2 - Audit Checklist
08/01/2016
CLIENT
STREET ADDRESS
20550 Townsen Blvd, Suite 2105
CITY, STATE, ZIP
Humble TX 77338 PH:
SCOPE OF AUDIT:
SPECIFICATION /
SERVICE / SERVICE-
RELATED PRODUCT
LOCATION OF AUDIT:
AUTHORITY:
PURPOSE:
AUDIT TEAM:
PRIMARY CONTACTS:
SUMMARY:
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
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 Organization’s 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 organization’s Corrective Action Process. The organization is to
identify all applicable requirements therein, including the API Spec, organization’s 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 organization’s 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:
VI. Confirmation of scope, QMS standards, auditor man-days and other instructions:
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:
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
Start Time:
End Time:
10. Confirm communication channels and language of the audit and reporting
NOTE: Identify all service processes applicable to the scope of registration (use additional pages as required).
IDENTIFY COMPONENT OF
THE QUALITY POLICY TO
OBJECTIVE FUNCTIONAL AREA MEASUREMENT METHOD
WHICH OBJECTIVE IS
TIED
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:
COMPLETE THE FOLLOWING USING PERSONNEL INTERVIEWED THROUGHOUT THE AUDIT (YES/NO RESPONSE ACCEPTABLE):
SELECT REPRESENTATIVE SAMPLING OF PERSONNEL PERFORMING WORK AFFECTING QUALITY.
COMPETENCE REQUIREMENTS INDIVIDUALS
CURRENT
PERSON / POSITION DETERMINED / VERIFIED AS AWARE OF THEIR
RECORDS EXIST
IDENTIFIED COMPETENT ROLES IN THE QMS
Identification,
Collection,
Storage,
Protection,
Retrieval,
Disposition of records?
Readily retrievable?
5
Additional comments/audit evidence regarding Document / Contract Review 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;
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 organization’s
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 supplier’s facility
to meet the organization’s purchasing requirements;
and
2) Verification that the supplier’s 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 organization’s
purchasing requirements;
ii. Verification that the supplier’s 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:
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.
SAMPLE SELECTED (REFERENCED ABOVE)
REQUIREMENT
1 2 3 4 5 6 CAR
Have criteria for selection/evaluation been defined?
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.
SAMPLE SELECTED (REFERENCED ABOVE)
REQUIREMENT 1 2 3 4 5 6 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:
Is the service quality plan updated when any of the plan content
changes?
Additional comments/audit evidence regarding Service Quality Plan Information activities:
Verification,
Storage,
Preservation,
Maintenance, and
Traceability
Transportation
Handling
Packaging
Storage
Protection
Inspection;
Maintenance;
Redress;
Repair;
Make-up;
Testing; and
Additional comments/audit evidence regarding Control of Testing, Measuring, Monitoring, and Detection Equipment activities:
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 CALIBRATION ANSWER YES / NO
EQUIPMENT TYPE SERIAL NO. CAL. DATE ACCURACY
FREQUENCY STATUS NIST* 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:
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 CAR (Y/N)
including API Spec requirements as applicable:
Audit Planning (Scope, Frequency, Importance, Results of Previous Audits): Roles and Responsibilities to Perform Audits (Auditors do not audit their
CAR (Y/N) own work): CAR (Y/N)
Nonconformities Identified (Number, Type, Detail): CAR (Y/N) Effective Follow-up to Nonconformities: CAR (Y/N)
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 service-
related 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?
Additional comments/audit evidence regarding Improvement activities:
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
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.
Additional comments / audit evidence regarding positive / negative aspects of the QMS (including opportunities for improvement, etc.):
Start Time:
End Time:
8. Inform client of the right to appeal any audit findings, nonconformities, and the recommendation
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
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.
END OF REPORT