Disclaimer
This GMP audit checklist is intended to aid in the systematic audit of a facility that manufactures drug components or finished products. The adequacy of any procedures is subject to the interpretation of the auditor. Therefore, ISPE and the GMP Institute accept no liability for any subsequent regulatory observations or actions stemming from the use of this audit checklist.
Instructions for Using 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.
GMP
Audit Checklist
Question |
Instructions/Questions |
1.0 |
General Controls |
|
Does the facility and its many
departments (organizational units) operate in a state of control as defined
by the GMP regulations? |
1.1 |
Organizational & Management
Responsibilities |
1.101 |
Does this
facility/business unit operate under a facility or corporate quality policy? |
1.102 |
§211.22(a) Does a
Quality Assurance unit (department) exist as a separate organizational
entity? |
1.103 |
§211.22(a) Does the
Quality Assurance unit alone have both the authority and
responsibility to approve or reject all components, drug product containers
and closures, in-process materials, packaging materials, labeling and drug
products? |
1.104 |
§211.22 Does the QA
department or unit routinely review production records to ensure that
procedures were followed and properly documented? |
1.105 |
§211.22(b) Are adequate
laboratory space, equipment, and qualified personnel available for required
testing? |
1.106 |
If any portion of
testing is performed by a contractor, has the Quality Assurance unit
inspected the contractor's site and verified that the laboratory space,
equipment, qualified personnel and procedures are adequate? |
1.107 |
Date of last inspection:____________________ |
1.108 |
§211.22(c) Are all QA
procedures in writing? |
1.109 |
§211.22(c) Are all QA
responsibilities in writing? |
1.110 |
Are all written QA
procedures current and approved? (Review log of procedures) |
1.111 |
Are the procedures
followed? (Examine records to ensure consistent record-keeping that
adequately documents testing.) |
1.112 |
§211.25 Are QA
supervisory personnel qualified by way of training and experience? |
1.113 |
§211.25 Are other QA
personnel, e.g., chemists, analysts, laboratory technicians) qualified by way
of training and experience? |
1.201 |
§211.22(a) Does the QA unit
have a person or department specifically charged with the responsibility of
designing, revising, and obtaining approval for production and testing
procedures, forms, and records? |
1.202 |
§211.22(d) Does a written SOP,
which identifies how the form is to be completed and who signs and
countersigns, exist for each record or form? |
1.203 |
§211.165(a)(b)(c) Is the
production batch record and release test results reviewed for accuracy and
completeness before a batch/lot of finished product is
released? |
1.3 |
Employee Orientation, Quality Awareness, and Job
Training |
1.301 |
Circle the types of orientation
provided to each new employee: (1) Company brochure (2) Literature describing
GMP regulations and stressing importance of following instructions. (3)
On-the-job training for each function to be performed (before the
employee is allowed to perform such tasks). (4) Other: enter in notebook. |
1.302 |
§211.25(a) Does each employee
receive retraining on an SOP (procedures) if critical changes have been made
in the procedure? |
1.303 |
Indicate how on-going,
periodic GMP training is accomplished. |
1.304 |
§211.25 is all training
documented in writing that indicates the date of the training, the type of
training, and the signature of both the employee and the trainer? |
1.305 |
§211.25 Are training records
readily retrievable in a manner that enables one to determine what training
an employee has received, which employees have been trained on a particular
procedure, or have attended a particular training program? |
1.306 |
Are GMP trainers qualified
through experience and training? |
1.307 |
§211.25(a) Are supervisory
personnel instructed to prohibit any employee who, because of any physical
condition (as determined by medical examination or supervisory observation)
that may adversely affect the safety or quality of drug products, from coming
into direct contact with any drug component or immediate containers for
finished product? |
1.308 |
§211.28(d) Are employees
required to report to supervisory personnel any health or physical condition
that may have an adverse effect on drug product safety and purity? |
1.309 |
§211.25(a) Are temporary
employees given the same orientation as permanent employees? |
1.310 |
§211.34 Are consultants, who
are hired to advise on any aspect of manufacture, processing, packing or
holding, of approval for release of drug products, asked to provide evidence
of their education, training, and experience? |
1.311 |
§211.34 Are written records
maintained stating the name, address, qualifications, and date of service for
any consultants and the type of service they provide? |
1.4 |
Plant Safety and Security |
1.401 |
Does this facility have a
facility or corporate safety program? |
1.402 |
Are safety procedures written? |
1.403 |
Are safety procedures current? |
1.404 |
Do employees receive safety
orientation before working in the plant area? |
1.405 |
Is safety training documented
in a readily retrievable manner that states the name of the employee, the
type of training, the date of the training, and the name of the trainer and
the signature of the trainer and the participant? |
1.406 |
Does this facility have a
formal, written security policy? |
1.407 |
Is access to the facility
restricted? |
1.408 |
Describe how entry is
monitored/restricted: |
1.409 |
Is a security person available
24 hours per day? |
1.5 |
Internal Quality/GMP Audit Program |
1.501 |
Does this business
unit/facility have a written quality policy? |
1.502 |
Is a copy of this quality
policy furnished to all employees? |
1.503 |
If "yes" to above,
when provided? __________________ |
1.504 |
Is training provided in
quality improvement? |
1.505 |
Does a formal auditing
function exist in the Quality Assurance department? |
1.506 |
Does a written SOP specify who
shall conduct audits and qualifications (education, training, and experience)
for those who conduct audits? |
1.507 |
Does a written SOP specify the
scope and frequency of audits and how such audits are to be documented? |
1.508 |
Does a written SOP specify the
distribution of the audit report? |
1.6 |
Quality Cost Program |
1.601 |
Does this facility have a
periodic and formal review of the cost of quality? |
1.602 |
Does this facility have the
ability, through personnel, software, and accounting records, to identify and
capture quality costs? |
1.603 |
Does this facility make a
conscious effort to reduce quality costs? |
Question |
Instructions/Questions |
2.0 |
Design Control |
|
Not directly related to 21 CFR
Parts 210 and 211 |
Question |
Instructions/Questions |
3.0 |
Facility Control |
3.1 |
Facility Design and Layout |
3.101 |
§211.42(a) Are all parts of
the facility constructed in a way that makes them suitable for the
manufacture, testing, and holding of drug products? |
3.102 |
§211.42(b) Is there sufficient
space in the facility for the type of work and typical volume of production? |
3.103 |
Does the layout and
organization of the facility prevent contamination? |
3.2 |
Environmental Control Program |
3.201 |
The facility is NOT situated
in a location that potentially subjects workers or product to particulate
matter, fumes, or infestations? |
3.202 |
Are grounds free of standing
water? |
3.203 |
§211.44 Is lighting adequate
in all areas? |
3.204 |
§211.46 Is adequate
ventilation provided? |
3.205 |
§211.46 Is control of air
pressure, dust, humidity and temperature adequate for the manufacture,
processing, storage or testing of drug products? |
3.206 |
§211.46 If air filters are
used, is there a written procedure specifying the frequency of inspection and
replacement? |
3.207 |
Are drains and routine
cleaning procedures sufficient to prevent standing water inside the facility? |
3.208 |
§211.42(d) Does the facility
have separate air handling systems, if required, to prevent contamination?
(MANDATORY IF PENICILLIN IS PRESENT!) |
3.3 |
Facility Maintenance and Good Housekeeping
Program |
3.301 |
§211.56(a) Is this facility
free from infestation by rodents, birds, insects and vermin? |
3.302 |
§211.56(c) Does this facility
have written procedures for the safe use of suitable, (e.g. those that are
properly registered) rodenticides, insecticides, fungicides, and fumigating
agents? |
3.303 |
Is this facility maintained in
a clean and sanitary condition? |
3.304 |
Does this facility have
written procedures that describe in sufficient detail the cleaning schedule,
methods, equipment and material? |
3.305 |
Does this facility have
written procedures for the safe and correct use of cleaning and sanitizing
agents? |
3.306 |
§211.58 Are all parts of the
facility maintained in a good state of repair? |
3.307 |
§211.52 Is sewage, trash and
other refuse disposed of in a safe and sanitary manner (and with sufficient
frequency?) |
3.4 |
Outside Contractor Control Program |
3.401 |
§211.56(d) Are contractors and
temporary employees required to perform their work under sanitary conditions? |
3.402 |
§163 Are contractors qualified
by experience or training to perform tasks that may influence the production,
packaging, or holding of drug products? |
4.0 |
Equipment Control |
4.1 |
Equipment Design and Placement |
4.101 |
§211.63 Is all equipment
used to manufacture, process or hold a drug product of appropriate design and
size for its intended use? |
4.102 |
Are the following pieces
of equipment suitable for their purpose? Blender(s), Conveyor(s), Tablet,
Presses, Capsule Fillers, Bottle Fillers, Other (specify). |
4.103 |
Are the following pieces
of equipment suitable in their size/capacity? Blender(s), Conveyor(s),
Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). |
4.104 |
Are the following pieces
of equipment suitable in their design? Blender(s), Conveyor(s), Tablet,
Presses, Capsule Fillers, Bottle Fillers, Other (specify). |
4.105 |
Are the locations in the
facility of the following pieces of equipment acceptable? Blender(s),
Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other
(specify). |
4.106 |
Are the following pieces
of equipment properly installed? Blender(s), Conveyor(s), Tablet, Presses,
Capsule Fillers, Bottle Fillers, Other (specify). |
4.107 |
Is there adequate space
for the following pieces of equipment? Blender(s), Conveyor(s), Tablet,
Presses, Capsule Fillers, Bottle Fillers, Other (specify). |
4.108 |
§211.65(a) Are machine
surfaces that contact materials or finished goods non-reactive,
non-absorptive, and non-additive so as not to affect the product? |
4.109 |
§211.65(b) Are design
and operating precautions taken to ensure that lubricants or coolants or
other operating substances do NOT come into contact with drug components or
finished product? |
4.110 |
§211.72 Fiber-releasing
filters are NOT used in the production of injectable products? |
4.111 |
§ 211.72 Asbestos
filters are NOT used in the production of products? |
4.112 |
Is each idle piece of
equipment clearly marked "needs cleaning" or "cleaned; ready
for service"? |
4.113 |
Is equipment cleaned
promptly after use? |
4.114 |
Is idle equipment stored
in a designated area? |
4.115 |
§211.67(a)(b) Are
written procedures available for each piece of equipment used in the
manufacturing, processing or holding of components, in-process material or
finished product? |
4.116 |
Do cleaning instructions
include disassembly and drainage procedure, if required, to ensure that no
cleaning solution or rinse remains in the equipment? |
4.117 |
Does the cleaning
procedure or startup procedure ensure that the equipment is systematically
and thoroughly cleaned? |
4.2 |
Equipment Identification |
4.201 |
§211.105 Are all pieces
of equipment clearly identified with easily visible markings? |
4.202 |
§211.105(b) Are all
pieces of equipment also marked with an identification number that
corresponds with an entry in an equipment log? |
4.203 |
Does each piece of equipment
have written instructions for maintenance that includes a schedule for
maintenance? |
4.204 |
Is the maintenance log
for each piece of equipment kept on or near the equipment? |
4.3 |
Equipment Maintenance & Cleaning |
4.301 |
§211.67(b) Are written
procedures established for the cleaning and maintenance of equipment and
utensils? |
4.302 |
Are these procedures
followed? |
4.303 |
§211.67(b)(1) Does a
written procedure assign responsibility for the cleaning and maintenance of
equipment? |
4.304 |
§211.67(b)(2) Has a
written schedule been established and is it followed for the maintenance and
cleaning of equipment? |
4.305 |
Has the cleaning
procedure been properly validated? |
4.306 |
§211.67(b)(2) If
appropriate, is the equipment sanitized using a procedure written for this
task? |
4.307 |
§211.67(b)(3) Has a
sufficiently detailed cleaning and maintenance procedure been written for
each different piece of equipment to identify any necessary disassembly and
reassembly required to provide cleaning and maintenance? |
4.308 |
§211.67(b)(3) Does the
procedure specify the removal or obliteration of production batch information
from each piece of equipment during its cleaning? |
4.309 |
Is equipment cleaned promptly
after use? |
4.310 |
Is clean equipment clearly
identified as "clean" with a cleaning date shown on the equipment? |
4.311 |
§211.67(b)(5) Is clean
equipment adequately protected against contamination prior to use? |
4.312 |
§211.67(b) Is equipment
inspected immediately prior to use? |
4.313 |
§211.67(c) Are written
records maintained on equipment cleaning, sanitizing and maintenance on or
near each piece of equipment? |
4.4 |
Measurement Equipment Calibration Program |
4.401 |
§211.68(a) Does the
facility have approved written procedures for checking and calibration of
each piece of measurement equipment? (Verify procedure and log for each
piece of equipment and note exceptions in notebook with cross reference.) |
4.402 |
§211.68(a) Are
records of calibration checks and inspections maintained in a readily
retrievable manner? |
4.5 |
Equipment Qualification Program |
4.501 |
§211.63 Verify that all pieces
of equipment used in production, packaging, and quality assurance are capable
of producing valid results. |
4.502 |
§211.68(a) When
computers are used to automate production or quality testing, have the
computer and software been validated? |
4.503 |
Have on-site tests of
successive production runs or tests been used to qualify equipment? |
4.504 |
Were tests repeated a
sufficient number of times to ensure reliable results? |
4.505 |
§211.63 Is each piece of
equipment identified to its minimum and maximum capacities and minimum and
maximum operating speeds for valid results? |
4.506 |
Have performance
characteristics been identified for each piece of equipment? (May be
provided by the manufacturer, but must be verified under typical operations
conditions.) |
4.507 |
Have operating limits and
tolerances for performance been established from performance characteristics? |
5.0 |
Material/Component Control |
5.1 |
Material/Component Specification and Purchasing
Control |
|
Although purchasing is not
specifically addressed in the current GMP regulation, incumbent upon user of
components and materials to ensure quality of product, material or component. |
5.101 |
Has each supplier/vendor of
material or component been inspected/audited for proper manufacturing
controls? (Review suppliers and audits and enter names, material supplied,
and date last audited in notebook.) |
5.2 |
Material/Component Receipt, Inspection, Sampling,
and Laboratory Testing |
5.201 |
§211.80(a) Does the
facility have current written procedures for acceptance/rejections of drug
products, containers, closures, labeling and packaging materials? (List
selected materials and components in notebook and verify procedures.) |
5.202 |
§211.80(d) Is each lot
within each shipment of material or components assigned a distinctive code so
material or component can be traced through manufacturing and distribution? |
5.203 |
§211.82(a) Does
inspection start with visual examination of each shipping container for
appropriate labeling, signs of damage, or contamination? |
5.204 |
§211.82(b) Is the number of
representative samples taken from a container or lot based on statistical
criteria and experience with each type of material or component? |
5.205 |
§211.160(b) Is the
sampling technique written and followed for each type of sample collected? |
5.206 |
Is the quantity of sample
collected sufficient for analysis and reserve in case retesting or
verification is required? |
|
Verify that the following
steps are included in written procedures unless more specific procedures are
followed: |
5.207 |
§211.84(c)(2) Containers
are cleaned before samples are removed. |
5.208 |
§211.84(c)(4) Stratified
samples are not composited for analysis. |
5.209 |
§211.84(c)(5) Containers
from which samples have been taken are so marked indicating date and
approximate amount taken. |
5.210 |
Each sample container is
clearly identified by material or component name, lot number, date sample
taken, name of person taking sample, and original container identification. |
5.211 |
§211.84(d)(1)(2) At
least one test is conducted to confirm the identity of a raw material (bulk
chemical or pharmaceutical) when a Certificate of Analysis is provided by
supplier and accepted by QA. |
5.212 |
If a Certificate of Analysis
is not accepted for a lot of material, then additional testing is conducted
by a written protocol to determine suitability for purpose. |
5.213 |
§211.84(d)(6)
Microbiological testing is conducted where appropriate. |
5.3 |
Material Component Storage and Handling |
|
(Verify that materials and
components are stored and handled in a way that prevents contamination,
mixups, and errors.) |
5.301 |
§211.42(b) Are incoming
material and components quarantined until approved for use? |
5.302 |
Are all materials handled in
such a way to prevent contamination? |
5.303 |
Are all materials stored off
the floor? |
5.304 |
Are materials spaced to allow
for cleaning and inspection? |
5.305 |
§211.122(d) Are labels
for different products, strengths, dosage forms, etc., stored separately with
suitable identification? |
5.306 |
Is label storage area limited
to authorized personnel? |
5.307 |
§211.89 Are rejected
components, material, and containers quarantined and clearly marked to
prevent their use? |
5.4 |
Inventory Control Program |
5.401 |
§211.142 Are inventory control
procedures written? |
5.402 |
Does the program identify
destruction dates for obsolete or out-dated materials, components, and
packaging materials? |
5.403 |
§211.150(a) Is stock rotated
to ensure that the oldest approved product or material is
used first? |
5.404 |
§211.184(e) Is destruction of
materials documented in a way that clearly identifies the material destroyed
and the date on which destruction took place? |
5.5 |
Vendor (Supplier) Control Program |
5.501 |
Are vendors periodically
inspected according to a written procedure? |
5.502 |
Is the procedure for
confirming vendor test results written and followed? |
Question |
Instructions/Questions |
6.0 |
Operational Control |
6.1 |
Material/Component/Label Verification, Storage,
and Handling |
6.101 |
§211.87 Do written procedures
identify storage time beyond which components, containers, and closures must
be reexamined before use? |
6.102 |
§211.87 Is release of
retested material clearly identified for use? |
6.103 |
Are retesting information
supplements originally obtained? |
6.104 |
Do written procedures identify
steps in the dispensing of material for production? |
6.105 |
Do these procedures include
(1) release by QC, (2)Documentation of correct weight or measure, and (3)
Proper identification of containers? |
6.106 |
Does a second person observe
weighing/measuring/dispensing and verify accuracy with a second signature? |
6.107 |
§211.101(c) Is the addition of
each component documented by the person adding the material during
manufacturing? |
6.108 |
§211.101(d) Does a second
person observe each addition of material and document verification with a
second signature? |
6.109 |
§211.125(a) Does a written
procedure specify who is authorized to issue labels? |
6.110 |
§211.125(a) Does a written
procedure specify how labels are issued, used, reconciled with production,
returned when unused, and the specific steps for evaluation of any discrepancies? |
6.111 |
§211.125(d) Do written
procedures call for destruction of excess labeling on which lot or control
numbers have been stamped or imprinted? |
6.2 |
Equipment/Line/Area Cleaning, Preparation, and
Clearance |
6.201 |
§211.67(b)(5) Do written
procedures detail how equipment is to be checked immediately prior to use for
cleanliness, removal of any labels and labeling from prior print operations? |
6.202 |
§211.67(b)(3) Do written
procedures detail any disconnection and reassembly required to verify
readiness for use? |
6.3 |
Operational Process Validation and Production
Change Order Control |
6.301 |
Have production procedures
been validated? (Review selected procedures for validation
documentation. Adequate?) |
6.302 |
§211.100(a) Does the process
control address all issues to ensure identity, strength, quality and purity
of product? |
6.303 |
§§211.101(a) Does the
procedure include formulation that is written to yield not less than 100% of
established amount of active ingredients? |
6.304 |
§211.101(c) Are all weighing
and measuring preformed by one qualified person and observed by a second
person? |
6.305 |
§211.101(d) Have records
indicated preceding policy been followed by presence of two signatures? |
6.306 |
§211.103 Are actual
yields calculated at the conclusion of appropriate phases of the operation
and at the end of the process? |
6.307 |
§211.103 Are calculations
performed by one person? Is there independent verification by a second
person? |
6.4 |
In-Process Inspection, Sampling, and Laboratory
Control |
6.401 |
§211.110(a) Are written
procedures established to monitor output and validate the performance of
manufacturing procedures that may cause variability in characteristics of
in-process materials and finished drug products? |
6.402 |
§211.110(c) Are in-process
materials tested at appropriate phases for identity, strength, quality,
purity and are they approved or rejected by Quality Control? |
6.403 |
§211.160(b) Are there
laboratory controls including sampling and testing procedures to assure
conformance of components, containers, closures, in-process materials, and
finished product specifications? |
6.5 |
Reprocessing/Disposition of Materials |
6.501 |
§211.115(a) Do written
procedures identify steps for reprocessing batches? |
6.502 |
§211.115(b) Are quality
control review and approval required for any and all reprocessing of
material? |
6.503 |
Does testing confirm that
reprocessed batches conform to established specification? |
6.504 |
Does a written procedure
outline steps required to reprocess returned drug products (if it can be
determined that such products have not been subjected to improper storage
conditions?) |
6.505 |
Does Quality Control review
such reprocessed returned goods and test such material for conformance to
specifications before releasing such material for resale? |
7.0 |
Finished Product Control |
7.1 |
Finished Product Verification, Storage, and
Handling |
7.101 |
§211.30 Do written procedures
indicate how and who verifies that correct containers and packages are used
for finished product during the finishing operation? |
7.102 |
§211.134(a) In addition, do
written procedures require that representative sample of units be visually
examined upon completion of packaging to verify correct labelling? |
7.103 |
§211.137(a) Are expiration
dates stamped or imprinted on labels? |
7.104 |
§211.137(b) Are expiration
dates related to any storage conditions stated on the label? |
7.105 |
§211.142(a) Are all
finished products held in quarantine until QC has completed its testing and
releases product on a batch to batch basis for sale? |
7.106 |
§211.142(o) Is finished
product stored under appropriate conditions of temperature, humidity, light,
etc. |
7.2 |
Finished Product Inspection, Sampling, Testing,
and Release for Distribution |
7.201 |
§211.166 Has the formulation
for each product been tested for stability based on a written protocol?
(Containers must duplicate those used in final product packaging.) |
7.202 |
§211.166 Are written
sampling and testing procedures and acceptance criteria available for each
product to ensure conformance to finished product specifications? |
7.203 |
§211.170(a) Is a quantity of
samples equal to at least twice the quantity needed for finished product
release testing maintained as a reserve sample? |
7.204 |
§211.167(a) Are
sterility and pyrogen testing performed as required? |
7.205 |
§211.167(b) Are specific
tests for foreign particles or abrasives included for any ophthalmic
ointments? |
7.206 |
§211.167(c) Do
controlled release or sustained release products include tests to determine
conformance to release time specification? |
7.3 |
Distribution Controls |
7.301 |
§211.150(a) Does a written
procedure manage stocks to ensure that oldest approved product is sold first? |
7.302 |
§211.150(a) Are
deviations to the policy above documented? |
7.303 |
§211.150(a) Does a
written procedure identify the steps required if a product recall is
necessary? |
7.304 |
Is the recall policy current
and adequate? |
7.4 |
Marketing Controls |
7.401 |
The current regulation does
not address marketing controls per se except that all finished products must
meet their specifications. |
7.5 |
Complaint Handling and Customer Satisfaction
Program |
7.501 |
§211.198(a) Are complaints,
whether received in oral or written form, documented in writing and retained
in a designated file? |
7.502 |
§211.198(a) Are
complaints reviewed on a timely basis by the Quality Control Unit? |
7.503 |
§211.198(b)(1) Is the action
taken in response to each complaint documented? |
7.504 |
§211.198(b)(3) Are
decisions not to investigate a complaint also documented and
the name of the responsible person documented? |
7.505 |
§211.198(b)(2) Are complaint
investigations documented and do they include investigation steps, findings,
and follow-up steps, if required? Are dates included for each entry? |
0 Comments