Vendor Company Name:
|
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Supplier Site Address:
|
Supplier Business Address
(if different):
|
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Phone No:
|
Phone No:
|
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Fax No:
|
Fax No:
|
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E Mail:
|
E Mail:
|
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Material supplied to Sydco, covered by this questionnaire:
|
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|
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|
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Is the Company a division/subsidiary
of another corporation?
|
Yes
|
No
|
N/A
|
|
If Yes, Please
Specify
|
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|
||||
|
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|
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|
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This questionnaire was completed by:
|
Name:
|
Job Title:
|
Date:
|
Signature:
|
All information contained
within this document
will be treated as confidential between the Supplier
and Buyer.
For ³Yes´ / ³No´ answers;
Please tick the box for the one which
applies, or select
³N/A´ (Not Applicable)
|
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Management Responsibility
|
|||
Is an organization chart available? If yes, please enclose
a copy.
|
Yes
|
No
|
N/A
|
Are there any written job descriptions defining
each individuals responsibilities
|
Yes
|
No
|
N/A
|
How many shifts
of operation are there in the Production Area? How many shifts of operation are there in QC Laboratory?
|
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Approximately how many
employees do you have?
- Site total
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- QA/QC
|
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- Production
|
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To whom does the QA/QC
Manager report?
|
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Does the company
have a policy
on EHS (Environmental, Health &
Safety)?
|
Yes
|
No
|
N/A
|
Does the company have a policy
on Quality?
|
Yes
|
No
|
N/A
|
Who is responsible for contacts
with Sydco with
regards to the
following areas: Quality:
Technical: Commercial:
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Are subcontractors (if used), used for significant steps or components in
Preparation of Sydco¶s products?
The term subcontractors includes both contracted operations within Production
and
the Laboratory
|
Yes
|
No
|
N/A
|
If ³Yes´, please list
and explain:
|
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|
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|
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|
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|
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|
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|
Can you please provide full Supply chain(s) for the referenced material(s) (i.e. Manufacturer, Testers, Providers of C of A / C of C,
Packers / Repackers and Storage &
Distribution)
|
Yes
|
No
|
N/A
|
If ³Yes´, please list
& explain:
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|
|||
|
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|
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|
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|
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|
Quality Management System
|
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What is the basis of your quality
system, i.e. ISO?
|
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Please state your
Certificate/Registration reference and appropriate dates:
|
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|
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|
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Have any regulatory agencies inspected your
facility in the last five years?
|
Yes
|
No
|
N/A
|
If µYes¶, by whom, when and what were
the results?
|
|||
|
|||
|
|||
|
|||
Are all procedures documented and approved?
|
Yes
|
No
|
N/A
|
Are there change
control procedures in place?
|
Yes
|
No
|
N/A
|
Is there a procedure to notify customers of change?
|
Yes
|
No
|
N/A
|
Are QA/QC responsibilities well
defined and independent?
|
Yes
|
No
|
N/A
|
Does QA/QC approve
all analytical specifications and methods?
|
Yes
|
No
|
N/A
|
How is a batch (standard quantity) defined?
|
|||
What is the batch numbering system? (Please explain
in detail)
|
|||
|
Do you assign shelf/expiry/retest-lives
for all materials (incoming &
produced)?
|
Yes
|
No
|
N/A
|
If ³Yes´, please provide details.
|
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Which department reviews and approves production procedures?
|
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Are reference samples retained?
|
Yes
|
No
|
N/A
|
If ³Yes´, for how long?
|
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For how long are records retained?
|
|||
Is there a self-audit program?
|
Yes
|
No
|
N/A
|
Incoming Goods
|
|||
Is a list of approved suppliers used?
|
Yes
|
No
|
N/A
|
Is there a documented procedure for approval of suppliers?
|
Yes
|
No
|
N/A
|
Does this include audit
of suppliers?
|
Yes
|
No
|
N/A
|
If bulk tankers are used, are they dedicated?
|
Yes
|
No
|
N/A
|
If not, is a cleaning certificate required?
|
Yes
|
No
|
N/A
|
Is there a system
for monitoring or reviewing suppliers¶ performance?
|
Yes
|
No
|
N/A
|
Are there documented procedures for:
- Inspecting material
|
Yes
|
No
|
N/A
|
- Testing material
|
Yes
|
No
|
N/A
|
Are established Purchase Specifications used?
|
Yes
|
No
|
N/A
|
What is the basis
for acceptance of raw materials, i.e. testing, receipt
of suppliers C of A or both?
|
|||
Is a sampling plan in place?
|
Yes
|
No
|
N/A
|
Is a testing plan in place?
|
Yes
|
No
|
N/A
|
Warehouse
|
|||
Are storage facilities/equipment/ rented
or personnel contracted?
|
Yes
|
No
|
N/A
|
If ³Yes´, please provide
details.
|
|||
Are receipt and release
procedures documented?
|
Yes
|
No
|
N/A
|
Is the supply chain documented?
|
Yes
|
No
|
N/A
|
How is material
status controlled? (i.e.
Physical, system or labelling)
|
|||
How is rejected
material controlled? (i.e. Physical, system or labelling)
|
|||
Is there an identified sampling area?
|
Yes
|
No
|
N/A
|
Are all containers identified?
|
Yes
|
No
|
N/A
|
Is a First-In-First-Out or First-Expiry-First-Out system in use? (Identify)
|
Yes
|
No
|
N/A
|
Are shelf life/expiration dates
used?
|
Yes
|
No
|
N/A
|
Is Temperature (T ), controlled and documented?
|
Yes
|
No
|
N/A
|
Comments:
|
|||
Is Relative humidity (RH%),
controlled and documented?
|
Yes
|
No
|
N/A
|
Comments:
|
Production
|
|||
Is there more than one site or plant
used for the manufacture
of the specified material(s)?
|
Yes
|
No
|
N/A
|
If ³Yes´, please provide details.
|
|||
Is plant equipment labelled
as to its status and contents?
|
Yes
|
No
|
N/A
|
Is Pipe work labelled?
|
Yes
|
No
|
N/A
|
Are critical processes validated?
|
Yes
|
No
|
N/A
|
Does process documentation include:
Process instructions
|
Yes
|
No
|
N/A
|
Cleaning instructions
|
Yes
|
No
|
N/A
|
Cleaning records
|
Yes
|
No
|
N/A
|
Area clearance
|
Yes
|
No
|
N/A
|
Are cleaning processes validated?
|
Yes
|
No
|
N/A
|
Is there traceability throughout the process?
|
Yes
|
No
|
N/A
|
Is there an in-process monitoring system?
|
Yes
|
No
|
N/A
|
Is there an equipment use log?
|
Yes
|
No
|
N/A
|
Are all critical instruments calibrated?
|
Yes
|
No
|
N/A
|
Is there a preventative maintenance program?
|
Yes
|
No
|
N/A
|
Is reprocessing allowed?
|
Yes
|
No
|
N/A
|
Is there a non-conformance procedure?
|
Yes
|
No
|
N/A
|
Is the yield checked
against defined limits?
|
Yes
|
No
|
N/A
|
Are different grades of material produced?
|
Yes
|
No
|
N/A
|
If µYes¶, how and at what stage are these differentiated/selected?
|
|||
Is the plant dedicated or multi purpose?
|
|||
If the plant is multi purpose,
what other types of materials are produced in the unit(s)?
|
|||
Please list any hazardous materials that are manufactured on your site (whether in dedicated or multi
purpose facilities). E.g. herbicides.
|
|||
If available, please enclose
a brief process
flow, and
if possible include where in-process controls
are performed.
|
Packing
|
|||
Are packing operations segregated from production?
|
Yes
|
No
|
N/A
|
Are barcode readers in use?
|
Yes
|
No
|
N/A
|
Are areas labelled with
the product being packed?
|
Yes
|
No
|
N/A
|
Are re-usable containers used?
|
Yes
|
No
|
N/A
|
Are cleaning procedures in place?
|
Yes
|
No
|
N/A
|
Are controlled procedures used for
issuing labels and labelling?
|
Yes
|
No
|
N/A
|
Are label details checked?
|
Yes
|
No
|
N/A
|
Are there label reconciliation procedures?
|
Yes
|
No
|
N/A
|
Are there label disposal procedures?
|
Yes
|
No
|
N/A
|
How are containers security sealed?
|
|||
Is material clearly labelled, including waste and reject
material?
|
Yes
|
No
|
N/A
|
Computerized Systems
|
|||
Do you have a list of the Computerized systems used by this facility?
|
Yes
|
No
|
N/A
|
If ³Yes´, do you identify the Computerized systems that are considered to have an impact on Quality
of Product, or Service offered?
|
Yes
|
No
|
N/A
|
If ³Yes´, how is this documented?
|
|||
Does your Quality
system cover the
quality of Computerized systems?
|
Yes
|
No
|
N/A
|
Do you have procedures in place for disaster recovery and restoring of data archives?
|
Yes
|
No
|
N/A
|
Do you have access
security levels for the Computerized systems?
|
Yes
|
No
|
N/A
|
Do your procedures for validation cover the Computerized systems?
|
Yes
|
No
|
N/A
|
Do you have anti-virus protection?
|
Yes
|
No
|
N/A
|
Does the Change Control
procedure include Computerized systems?
|
Yes
|
No
|
N/A
|
Laboratories, QA & QC
|
|||
Is an equipment use log in place?
|
Yes
|
No
|
N/A
|
Are all instruments qualified (IQ, OQ, PQ)?
|
Yes
|
No
|
N/A
|
Are all instruments calibrated?
|
Yes
|
No
|
N/A
|
Is there a preventative maintenance program?
|
Yes
|
No
|
N/A
|
Are there documented procedures for:
Sampling
|
Yes
|
No
|
N/A
|
Sample handling
|
Yes
|
No
|
N/A
|
Sample labelling
|
Yes
|
No
|
N/A
|
Re-testing / Re-sampling
|
Yes
|
No
|
N/A
|
Specification generation
|
Yes
|
No
|
N/A
|
Analytical method
generation
|
Yes
|
No
|
N/A
|
Control and review of analytical methods
|
Yes
|
No
|
N/A
|
Investigation of rejected material
|
Yes
|
No
|
N/A
|
Product complaints
|
Yes
|
No
|
N/A
|
Handling out of specification results
|
Yes
|
No
|
N/A
|
Are manual calculations checked by a second
person?
|
Yes
|
No
|
N/A
|
Are data transcriptions checked
by a second person?
|
Yes
|
No
|
N/A
|
Is all raw-data retained?
|
Yes
|
No
|
N/A
|
Are all standards traceable to their preparation and the reagents used?
|
Yes
|
No
|
N/A
|
Are analytical methods validated?
|
Yes
|
No
|
N/A
|
Do you perform stability testing on materials and/or products?
|
Yes
|
No
|
N/A
|
If so, what
shelf life / retest dates
are available for the
referenced product(s)?
|
|||
Do you perform annual product reviews
or campaign
reviews
on
products?
|
Yes
|
No
|
N/A
|
Material Release
|
|||
Is the decision to release/reject product made by a person or function
independent from production?
|
Yes
|
No
|
N/A
|
Is the final status recorded?
|
Yes
|
No
|
N/A
|
Are certificates issued for each batch?
|
Yes
|
No
|
N/A
|
Are certificates signed by QA/QC?
|
Yes
|
No
|
N/A
|
If not, who signs certificates?
|
|||
Is shelf life
or retest dates
or expiry date provided
on the ³C of A ³ OR
³C of C¶s´
|
Yes
|
No
|
N/A
|
Is there a documented recall procedure?
|
Yes
|
No
|
N/A
|
Transport
|
|||
Is a list of approved hauliers in use?
|
Yes
|
No
|
N/A
|
Is temperature controlled transports used?
|
Yes
|
No
|
N/A
|
If ³Yes´, are temperature records reviewed and retained?
|
Yes
|
No
|
N/A
|
If bulk tankers are used, is a cleaning certificate required?
|
Yes
|
No
|
N/A
|
If bulk tankers are used, are they dedicated?
|
Yes
|
No
|
N/A
|
If not, what other substances could be transported in the tankers?
|
If Agent/Distributor involved, is the pipe work used on delivery
to the
agent/distributor dedicated?
|
Yes
|
No
|
N/A
|
Are the Agent/Distributor storage
facilities dedicated?
|
Yes
|
No
|
N/A
|
If ³No´, what other
substances are stored
in the facilities?
|
|||
Does the Agent/Distributor use dedicated filling lines?
|
Yes
|
No
|
N/A
|
What instructions are given to the haulier
for delivery to a Sydco
site e.g. dedicated hoses, dedicated tanks, dedicated pumps, temperature control, and paperwork to accompany delivery?
|
Facilities &
Housekeeping
|
|||
Are there procedures for health and hygiene?
|
Yes
|
No
|
N/A
|
Are rest/change/wash facilities separated from production areas?
|
Yes
|
No
|
N/A
|
Are access restrictions implemented as needed?
|
Yes
|
No
|
N/A
|
Do any production areas
have special containment needs?
|
Yes
|
No
|
N/A
|
Are waste disposal systems in place?
|
Yes
|
No
|
N/A
|
Are there procedures documenting a pest control
program?
|
Yes
|
No
|
N/A
|
Are material Safety Data Sheets maintained?
|
Yes
|
No
|
N/A
|
Training
|
|||
Is there a written
training program?
|
Yes
|
No
|
N/A
|
Are job-training needs evaluated?
|
Yes
|
No
|
N/A
|
Is completed training evaluated and approved?
|
Yes
|
No
|
N/A
|
Are there completed written
training records for all
employees?
|
Yes
|
No
|
N/A
|
Questionnaire reviewed for Buyer lead audit site
by:
|
Name:
|
Title:
|
Date:
|
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