Audit Checklist For Food Industry Part 1
Disclaimer
This checklist is intended to aid in the systematic GMP audit of a facility that
manufactures or processes food.
The adequacy of any procedures is subject to the interpretation of the
auditor. Therefore, the GMP Institute accepts no liability for any subsequent
regulatory observations or actions stemming from the use of this audit
checklist.
Instructions for Using GMP Institute Audit Checklist
Before starting an on-site audit, plan the audit. Review past audits,
note indications of possible problem areas, and items, if any, that were
identified for corrective action in a previous audit. If you are not already familiar
with this facility, learn the type of product produced here and how it is organized by
personnel and function. What does your "customer", i.e., your superior
or senior facility management, expect to learn from this audit?
- The checklist is to be used with a notebook into which detailed entries
can be made during the audit.
- While the checklist is to guide the auditor, is not intended to be a
substitute for knowledge of the GMP regulations.
- Although a single question may be included about any requirement, the
answer will usually be a multi-part one since the auditor should determine
the audit trail for several products that may use many different components.
Enter details in your notebook and cross reference your comments with the
questions.
- At least three production batches should be selected for thorough analysis
to include: (a) traceability of all components or materials used in the
subject batches, (b) documentation of raw material or component, in-process,
and finished goods testing for the subject product batches, (c) warehousing
and distribution records as they would relate to a possible recall.
- Responses entered on the checklist should be consistent. "X" is
recommended for "NO"; a checkmark for "YES";
"n/a" for not applicable to questions that do not apply. An
asterisk and notebook page number should be entered on the checklist to
identify where relevant comments or questions are recorded in your notebook.
- The notebook used should be a laboratory-type notebook with bound pages. The notebook should be clearly labeled as to the audit type, date, and
auditor(s). Many auditors prefer to use a notebook for a single audit so it
may be filed with the checklist and the final report.
- The references to sections in the GMP regulation are for your convenience
should a question arise. In some instances, two or more sections within the
GMP regulation may have bearing on a specific subject. The headings in the
GMP regulation will usually offer some guidance on the areas covered in each
section.
- A general suggestion for a successful audit is to spend most of your time
on major issues and a smaller portion of your time on small issues. There
may be observations that you may wish to point out to supervisory personnel
that deserve attention, but do not belong in an audit report because they
are relatively insignificant. By the same token, too many small items
suggests a trend of non-compliance and deserve attention as such. When
citing these, be specific.
Sections 1 and 2
| Section |
Question |
Yes, No, or NA |
1.0
|
General Controls
|
|
| 1.001 |
Does the facility and its many departments or
organizational
units operate in a state of control? |
|
| 1.1 |
Organization and Management Responsibilities |
|
| 1.101 |
§110.80 Is there an appropriate quality control operation
employed to ensure that food is suitable for human consumption and that
food packaging material is safe and suitable? |
|
| 1.102 |
§110.3(i) Is there a planned and systematic procedure
for taking all actions necessary to prevent food from being adulterated
within the meaning of the FD&C Act? |
|
| 1.103 |
§110.80 Is there one or more competent individual(s)
assigned responsibility for the supervision of the plant sanitation
program? |
|
| 1.104 |
§110.10(d) Is the responsibility for assuring
compliance by all personnel with the requirements of the GMP regulation
clearly assigned to competent supervisory personnel? |
|
| 1.105 |
Is there a formal, multidisciplinary plant food safety
committee performing complete inspections of the entire facility at least
monthly? |
|
| 1.106 |
Is a functional organizational chart maintained? |
|
| 1.107 |
Do all departments involved in implementing food product
safety have adequate budgets established for the timely acquisition and
maintenance of tools, materials, and equipment? |
|
| 1.2 |
Document Control |
|
| 1.201 |
Is there an adequate procedure for writing, approving, and
distributing written procedures to the appropriate personnel? |
|
| 1.202 |
Is there a system for insuring the timely review of
procedures and for the prompt removal of obsolete procedures from the
system? |
|
| 1.203 |
Are there written procedures to delineate responsibilities
of departments for implementing quality control/quality assurance? |
|
| 1.204 |
Are there written procedures to delineate
responsibilities of departments for implementing the plant sanitation
program? |
|
| 1.205 |
Are there specific procedures for the inspection
of incoming raw materials? |
|
| 1.206 |
Are there written procedures for laboratory
analysis and sampling, whether conducted in-house or by an outside
laboratory? |
|
| 1.207 |
Are there written procedures or a written
program for evaluating complaints of adulteration or misbranding? |
|
| 1.208 |
Are there written procedures to prevent
adulteration of food or raw materials from pests or from the application
of pesticides, rodenticides, insecticides, etc.? |
|
| 1.209 |
Are there written procedures, including
schedules, for cleaning? |
|
| 1.210 |
Are there written procedures for handling
regulatory inspections? |
|
| 12.11 |
§113.100(a) Is processing and production
information for low acid can foods (LACF) entered when it is observed by
the processing system operator? |
|
| 1.212 |
Are adequate records maintained for LACF's per
§113.100(a) for: |
|
|
(a) Still retorts? |
|
|
(b) Agitating retorts? |
|
|
(c) Hydrostatic
retorts? |
|
|
(d) Aseptic processing
& packaging systems? |
|
|
(e) Flame sterilizers? |
|
|
(f) Food preservation
methods? |
|
|
(g) Critical factors
specified in the formulation of the product or scheduled process? |
|
| 1.213 |
Are recording thermometer charts for LACF's
identified by date, retort number, and other data per §113.100(b) |
|
| 1.214 |
§113.100(b) Are all processing and
production records for LACF's reviewed and signed or initialed by a
qualified representative of plant management no later than 1 day after the
actual process and before shipment or release for distribution? |
|
| 1.215 |
Do written records for LACF container/closure
examinations specify: product code, date & time of inspection,
measurement obtained, and corrective action taken per §113.100(c) |
|
| 1.216 |
§§113.100(d) and 114.100(d) Are records
maintained for LACF and acidified foods to identify distribution of
finished product? |
|
| 1.217 |
§114.100(a) Are records maintained of
examinations of raw materials, packaging materials, finished product and
supplier's guarantees for acidified foods? |
|
| 1.218 |
§114.100(b) Are production and processing
records showing adherence to scheduled processes maintained for acidified
foods? |
|
| 1.3 |
Employee Orientation, Quality Assurance, and Job
Training Program |
|
| 1.301 |
§110.10(c) Do personnel responsible for
identifying plant sanitation failures or food contamination have the
combination of education and experience to produce clean, safe food? |
|
| 1.302 |
§110.10(c) Do food handlers and
supervisors have appropriate training in proper food handling techniques
and food protection principles? |
|
| 1.303 |
§§113.10 and 114.10 respectively. Have
those who supervise operators of retorts, processing systems, aseptic
processing and packaging systems and product formulation systems for
LACF's and acidified food attended a school approved by the
Commissioner? |
|
| 1.304 |
Is there an orientation for new employees on
food safety, employee safety and quality? |
|
| 1.305 |
Do temporary employees, contractors, and outside
service personnel receive basic food safety training? |
|
| 1.306 |
Is there initial and periodic training for all
who apply pesticides? |
|
| 1.307 |
§110.10(a) Are employees instructed to
report health conditions that might contaminate food, food product
surfaces or food packaging materials to their supervisor? |
|
| 1.308 |
§110.10(b) Are employees trained to
protect against contamination of food by properly wearing suitable outer
garments, hair nets, beard coverings, etc.? |
|
| 1.309 |
§110.10(b) Are employees trained to
wash hands thoroughly before work and after each absence from their work
station? |
|
| 1.310 |
§110.10(b) Are employees trained to
remove unsecured jewelry and other objects that might fall into food? |
|
| 1.311 |
§110.10(b) Are employees trained to confine
eating, drinking, gum chewing, and use of tobacco to areas where food is
not exposed or equipment and utensils are not washed? |
|
| 1.4 |
Plant Safety and Security |
|
| 1.401 |
Does the facility have a plant safety program? |
|
| 1.402 |
Are Material Safety Data Sheets readily
available for all chemicals used in the facility? |
|
| 1.403 |
Are there written safety procedures? |
|
| 1.404 |
Is there adequate safety equipment in each area
of the facility? |
|
| 1.405 |
Have employees and contractors received adequate
safety training? |
|
| 1.406 |
Is access to the facility restricted? |
|
| 1.407 |
Is proprietary information identified and
adequately secured? |
|
| 1.408 |
Are all computer systems regularly backed up and
is the backup data stored in separate facility? |
|
| 1.5 |
Internal Quality System and Audit Program |
|
| 1.501 |
Does the facility have a Quality Policy? |
|
| 1.502 |
Is the Quality Policy distributed to all
employees? |
|
| 1.503 |
Does the facility have a formal internal audit
program? |
|
| 1.504 |
Is there a written procedure for internal audits
that describes: who shall conduct the audits, the frequency of audits, how
audits are documented, and the distribution of audit reports? |
|
| 1.505 |
Is there a written procedure that describes how
to handle an FDA audit? |
|
| 1.6 |
Quality Cost Program |
|
| 1.601 |
Does the facility have a formal, periodic review
of the cost of quality? |
|
| 1.602 |
Does the facility have the capability through
trained personnel, adequate accounting records and computer software to
identify and capture quality costs? |
|
| 1.603 |
Is there a conscious effort to communicate
quality cost savings to the workforce? |
|
2.0
|
Design Control
|
|
| |
Does not apply to the Food Industry |
|
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|
