Formulation Assessment Form

advertisement
BuildCert Ltd - CIAS Formulation Assessment Form
FORM: BC29
Page 1 of
Audit Reference:
Issue No.2
Date of Issue: June 2015
Company Name:
Address:
Company representatives:
Bottler Name:
Current BuildCert Approval No:
BuildCert Auditor:
Date of Audit:
Commentary if required upon the licence holder and the working relationship between the manufacture/bottler/supplier :
BuildCert Ltd - CIAS Formulation Assessment Form
FORM: BC29
Page 2 of
Audit Reference:
Audit Summary
Issue No.2
Date of Issue: June 2015
BuildCert Ltd - CIAS Formulation Assessment Form
FORM: BC29
Page 3 of
Audit Reference:
Issue No.2
1. Verification of formulation information
With reference to the formulation details held on record with BuildCert

Confirm with the certificate holder whether this information is
still current?
If not :

Are there ingredient variations?

Supplier variations

Variations in amounts of ingredients?

Variations in tolerances on amounts?
2. Specific ingredient information
Note any variations of ingredient suppliers between BuildCert
records, purchasing database, shipping receipts, and / or ingredient
inventory
Ingredient storage

Do adequate environmental and contamination control
procedures exist for the storage of ingredients?

Are the dates of receipt of ingredients and dates of expiry
recorded?
Identify specific ingredients to be audited
Date of Issue: June 2015
BuildCert Ltd - CIAS Formulation Assessment Form
FORM: BC29
Page 4 of
Audit Reference:
Issue No.2
Date of Issue: June 2015
Amounts of ingredients utilised in production over a specific time period

Amounts of ingredients utilised in production over a specific
time period
Amount: ………………………………………………….
Time Period: …………………………………………….
Product and ingredient identification

Are all ingredients and finished products labelled in storage?
Product and ingredient traceability

Are the dates of purchase and supplier sources for all
ingredients and production aids for manufacturing of the
listed products documented?

Is documentation available which gives the production dates,
shipment dates, and the customer identifications for the
listed products?

Indicate an example of a lot number code.

Detail how the raw material lot numbers relate to the lot
numbers of finished products

Is there full traceability of the product through the production
process via batch / lot code, etc.?
Product and ingredient specifications (as applicable)

Is documentation available which establishes the
manufacturer’s ingredient specifications and requirements?

Is documentation available which establishes the
manufacturer’s quality control specifications for finished
products?
BuildCert Ltd - CIAS Formulation Assessment Form
FORM: BC29
Page 5 of
Audit Reference:

Issue No.2
Itemise QC test performed on the listed products
Procedures for production (as applicable)

Is documentation available which describes the production
methods and processes for the listed product?
Equipment calibration (as applicable)

Is documentation available which establishes calibration
frequencies for equipment that is used at critical control
points in the production process, and calibration procedures?

Can the established calibration frequencies and procedures
be verified as followed within the site?
Handling, storage, packaging, preservation and delivery specifications

Is documentation available which identifies the product shelf
life requirements and inventory control conditions?

Is documentation available which identifies the product
container specifications for finished product shipments and
delivery specifications to prevent contamination?

Is bulk product dispatched to a 3rd party for bottling?

Is documentation available for bottling the product by a 3rd
party?

Has the 3rd party bottler been audited by BuildCert?
3. Review of quality system

Is the company ISO 9001 certified, or quality audit assessed
by BuildCert?
If ISO 9001 certified :
Date of Issue: June 2015
BuildCert Ltd - CIAS Formulation Assessment Form
FORM: BC29
Page 6 of
Audit Reference:
Issue No.2

Is the certificate current?

Does the certificate apply to this site?

Is the scope of certification applicable to the production of
this product?

When was the company last assessed by their certification
body?

Were there any findings raised that could impact on this
BuildCert approval?
Date of Issue: June 2015
If so, have these been addressed satisfactorily?
If a quality audit is undertaken by BuildCert :

When was the last audit undertaken?

If any corrective actions were raised, have these been
instigated and are they operating effectively?
4. Specific ingredient information

Can the manufacturer provide a copy of the ‘Instructions for
Use’ document for the product?
___________________________________________________________________________________________________________________
** NOTE: This section only applies if expressly requested by BuildCert **
5. Collection of samples for performance audit testing: Yes/No delete as appropriate

Were samples collected from production or stock?

Record the lot / batch number of products
BuildCert Ltd - CIAS Formulation Assessment Form
FORM: BC29
Page 7 of
Audit Reference:

Issue No.2
Date of Issue: June 2015
Samples were bonded and forwarded to BuildCert on :
Additional comments from the assessor:
Signed: ……………………………………… (Company management representative) Position: ………………………………………………………..
Signed: ……………………………………… (BuildCert Auditor)
Date: …………………………………………………………….
Download