An audit is a systematic, independent examination to determine if quality activities and results comply with planned arrangements and if those arrangements are effectively implemented and suitable to achieve objectives. Audits are performed to collect objective evidence that allows for an informed judgment about the system or product being audited. There are internal audits performed by a company's own employees and external audits performed by outside parties like customers or independent organizations. The goal of audits is to determine compliance and ensure quality.
2. A systematic and independent examination to
determine whether quality activities and related
results comply with planned arrangements, and
whether these arrangements are implemented
effectively and are suitable to achieve objectives
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3. To collect objective evidence to permit an informed
judgment about the status of the systems or product
being audited
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4. Internal (First Party, Self)
This type includes audits by company employees,
consultants and contractors
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5. External
i. Supplier Audit
○ Second Party
Customer employee(s) audit your company
or
Your employee(s) audit a company which
supplies your company with a product or
service
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6. ii. Independent Organization
Third Party Audit
○ A customer wants an audit of your company
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7. 1. Compliance (do we comply with the standard)
Example: Desk audit of high level systems
2. System (the theory)
Example: Audit of Document Control
3. Process (the practice)
Example: Audit of any process (manufacturing)
4. Product (the result)
Example: Audit of finished products to fulfil
technical specifications
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8. 1. Auditor: A person who has appropriate qualifications
and performs audits.
2. Client: A person or organization requesting the audit.
For internal audits, this is the Management
Representative.
3. Auditee: An organization, facility or person being
audited.
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9. 4. Quality System: The organizational structure,
responsibilities, procedures, processes and
resources for implementing quality management.
5. Observation: A statement of fact made during an
audit and substantiated by objective evidence.
6. Nonconformity: The non-fulfillment of specified
requirements.
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10. 7. Objective Evidence: Qualitative or quantitative
information, records or statements of fact pertaining
to the quality of an item or service or to the
existence and implementation of a quality system
element, which is based on observation,
measurement or test and which can be verified.
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11. (A) Imposed upon
manufacturer or
supplier
Third party (on
Customer, or
Regulatory behalf of
potential customer
customer)
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12. (B) Performed by
manufacturer
(i) Internal (self-
(ii) External
inspection)
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14. • Determine the level of compliance
• Build confidence (hopefully) in GMP and the QA system
• Build interdepartmental trust, understanding, and communication
(if the audit is done properly and tactfully)
• Determine measures necessary to improve, e.g.,:
• Premises, equipment, environment
• Operations, actions, procedures
• Personnel/training
• Provide a stimulus for improvement
• Recommend corrective action
• Monitor improvement
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15. • Establish and monitor capability of supplier or
contractor to deliver
• goods and services that are fit for purpose (and on
time, and in the quantity required)
• Build mutual confidence
• Promote understanding and communication
between the parties involved (both sides can learn!)
• And in general, as listed for “internal”
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16. Plan and
prepare
Arrange and
Follow-up
announce
Arrive at site of
Formal report, with
audit, meet, explain
recommendations
purpose
Informal oral
Perform
report of
audit
finding
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18. examination of
1. established methods
2. instructions
3. work flow for processes
4. maintenance programs for production equipment
5. material handling
6. housekeeping around the work area
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19. Here company’s procedures are validated
Processes are sub-parts of a system.
Process audits are generally a part of larger system(s)
audit.
However , they can be performed independently
○ An internal audit may indicate need to perform a specific
process audit
Almost always, one or more other process(es) will interact
with any given process.
One very important issue to consider is the effectiveness of
communications between systems and/or processes.
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21. 1. Documents
a. Quality and GMP regulations, standards, and guidelines
(local, national, and international)
b. Previous audit and follow-up reports
c. Auditee’s own documents and records
d. Audit checklists
requires that auditor evaluates a certain number of
procedures, plans and documents
2. The auditors own eyes, ears, brain, words, character, etc.
3. The auditing plan
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22. 1. Is there a documented sanitation program?
2. Are the specifics of the program followed?
3. Are there standard operating procedures (SSOPs)?
4. Is a pre-operational audit conducted prior to production?
5. Are corrective actions taken in response to pre-op
findings?
6. What are the general conditions in the plant?
7. Are the floors, walls and ceilings in good condition?
8. Are the exterior structure and grounds maintained in a
condition to prevent contamination?
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