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: …………………………………………………………….