Pre-audit questionnaires for Raw Material Suppliers

Pre-audit questionnaires play a crucial role in this process by providing an in-depth initial assessment of potential suppliers. In this article, we’ll explore what pre-audit questionnaires are, why they are important, and how to design an effective questionnaire for raw material suppliers.

What are Pre-Audit Questionnaires?

Pre-audit questionnaires are structured documents designed to gather detailed information from potential suppliers before an on-site audit. These questionnaires are typically sent to suppliers during the supplier evaluation process to assess their capabilities, quality standards, and adherence to industry regulations and best practices.

The goal of pre-audit questionnaires is to streamline the supplier selection process, identify potential risks, and ensure alignment with a company’s quality, safety, and sustainability standards. 

Why Are Pre-Audit Questionnaires Important?

1. Risk Mitigation: Pre-audit questionnaires help identify potential risks associated with a supplier's operations, such as non-compliance with safety regulations or quality control issues.
2. Quality Assurance: By assessing a supplier's quality control processes, companies can ensure that the raw materials meet their specific requirements and standards.
3. Compliance: Suppliers are asked about their adherence to relevant laws, regulations, and industry standards, helping companies avoid legal and reputational risks.
4. Sustainability: Companies increasingly seek suppliers that prioritize sustainability and ethical practices. Pre-audit questionnaires can evaluate a supplier's commitment to environmentally friendly and ethical practices.
5. Streamlined Audit Process: By gathering information in advance, pre-audit questionnaires streamline the on-site audit process, allowing auditors to focus on key areas of concern.

ALSO READ: Vendor Audit Checklist in Pharmaceutical Industry

Pre-audit Questionnaires for Raw Material Suppliers

Name of the Company:
Name of Parent Company:
Does your company issue an annual report with financial details? (If yes, please attach a copy with sales literature and product information)			YES / NO
Address of Manufacturing Plant:
Contacts:
Telephone No:		Fax No:
Materials Manufactured:
Major customers – Local:
Major customers – Export:
1.	ORGANIZATION:
1.1	No. of employees	Production: Quality Assurance: Total on site:
1.2	Work Pattern	Shift includes: First / second / third / and general. (strike out whichever is not applicable)
1.3	Contracts for employees	Permanent / Temporary / Casual
1.4	Size of site: Age of site:
1.5	Location Urban, Rural, Industrial Please attach organization chart showing key reporting relationships. (You may enclose separate attachment)
1.6	Have you implemented a Quality Assurance system in your firm?		YES / NO
1.7	Are you ISO 9000 accredited? Other accreditations – please list		YES / NO
1.8	Is the Quality Assurance function independent of the Production Management?		YES / NO
1.9	To whom does the Quality Assurance Management Report?
	(please attach Quality Policy)
2.	PERSONNEL:
2.1	Are your personnel aware that the PRODUCTS SUPPLIED are used for Pharmaceuticals?		YES / NO
2.2	Do you have written training programmes for Production and Quality Assurance personnel?		YES / NO
2.3	Do you assess the effectiveness of training?		YES / NO
	If yes, please indicate how below:
3.	BUILDING AND PREMISES:
3.1	Do you manufacture the product at more than one site?		YES / NO
	If yes, please add addresses of different locations.
3.2	Does the present design prevent?
	* Chemical contamination (smoke, fumes) of other materials in the atmosphere		YES / NO
	* Physical contamination (dust, substitution, intermixtures)		YES / NO
	* Microbial contamination		YES / NO
3.3	Do you have a written general housekeeping procedure?		YES / NO
3.4	Do you have a written sanitation procedure?		YES / NO
3.5	Do you have changing/toilet refreshment facilities physically separated from production/storage areas? Please attach Site plan		YES / NO
4.	EQUIPMENT:
4.1	Are written procedures available for?
	* Set-up, maintenance, cleaning, calibration of equipment		YES / NO
4.2	Are records kept for?
	* The sequence of products manufactured on particular equipment		YES / NO
5.	MANUFACTURE:
5.1	What is your definition of a lot (or batch)?
	* One manufacturing order		YES / NO
	* One blend of raw material		YES / NO
	* A series of lots blended		YES / NO
	* What is your normal batch size?
	* In case of sterile bulk raw material give detailed explanation about one lot
5.2	Does each lot have an identifying number?		YES / NO
5.3	Are your materials used on a first-in-first-out basis?		YES / NO
5.4	Do you combine the production from more than one piece of equipment into one lot?		YES / NO
5.5	Is your production derived totally from virgin material?		YES / NO
	If not, what proportion of the feed material is from recycled material? Is the stability of such material available?
5.6	Are the finished goods are handled in a classified area?		YES / NO
	If No, where?
5.7	Do you reconcile all identity labels?		YES / NO
5.8	Do you manufacture according to a written procedure and/or custom specification for each PRODUCT SUPPLIED?		YES / NO
5.9	Are these procedures agreed by Quality Assurance?		YES / NO
5.10	Do you keep following records of each lot manufactured with respect to?
	* Equipment used		YES / NO
	* Manufacturing order		YES / NO
	* Identification, quantity and lot number of materials used		YES / NO
	* Date of manufacture		YES / NO
	* The results of in-process control		YES / NO
	* An account for any deviation from the written procedure		YES / NO
5.11	Are these records formally checked by Quality Assurance?		YES / NO
5.12	Do you have a system of equipment cleaning and clearance?		YES / NO
5.13	Is line clearance given before packing?		YES / NO
5.14	Is there a record of examination of retained samples for the products reviewed?		YES / NO
5.15	Are rejected lots or parts of lots identified?		YES / NO
5.16	Do you retain samples of each lot? If so, for how long?
	Please attach flow chart of the manufacturing stages identifying key equipment
6.	PACKAGING / DISPATCH:
6.1	Are written procedures and specifications available for?
	* Packaging components		YES / NO
	* The packing operation		YES / NO
	* Labels and labeling		YES / NO
6.2	Does the labeling procedure emphasize the special precautions needed to avoid		YES / NO
	intermixtures / substitution?
6.3	Do you maintain lot integrity during packaging?		YES / NO
6.4	What is your normal packaging for material of our interest?
6.5	Are you prepared to meet packaging and labeling requirements of your customers?		YES / NO
6.6	Does your labeling indicate the site of manufacture?		YES / NO
6.7	What details do you place on your dispatch labels?
6.8	At what temperature the product is stored in finished goods stores?
6.9	Are your storage/distribution facilities designed to prevent contamination of the products?		YES / NO
7.0	QUALITY ASSURANCE PROCEDURES:
7.1	Does the Quality Assurance function include?
	* Evaluation and approve the product specifications and the manufacturing procedures as well as any modification thereof		YES / NO
	* Ensuring the approved raw material / packing material is used in the manufacturing		YES / NO
7.2	Are product quality aspects considered at the design stage with respect to?
	* New equipment		YES / NO
	* New area		YES / NO
	* New process		YES / NO
7.3	Do you operate a status labeling systems?		YES / NO
7.4	Do you operate a status label reconciliation system?		YES / NO
7.5	Are samples taken by Quality Assurance personnel?		YES / NO
7.6	Is in-process control the responsibility of Quality Assurance? If not, whose responsibility is it?		YES / NO
7.8	Is there any SOP for batch record review prior to release?		YES / NO
8.	LIAISON:
8.1	Are you prepared to provide your product specifications and/or drawings to your customers?		YES / NO
8.2	Are you prepared to communicate your test methods for PRODUCTS SUPPLIED?		YES / NO
8.3	Would you welcome the discussion of quality problems with your customers and potential customers?		YES / NO
8.4	Who should be contacted in the case of any questions concerning quality? Give details:
8.5	Would you issue Certificate of Analysis / Conformance?		YES / NO
8.6	Would you notify customers of?
	* Changes in site of manufacture		YES / NO
	* Changes in manufacturing processes that affect the product quality or chemical properties		YES / NO
8.7	Is there a written procedure for holding, testing and reprocessing returned drug products?		YES / NO
8.8	Is there any written procedure for the recall drug products that ensures that responsible officials of the firm are notified in writing of the recall?		YES / NO
9.	FOLLOWING DOCUMENTS ARE ATTACHED:
9.1	Annual Report / and Sales Literature		YES / NO
9.2	Organization chart		YES / NO
9.3	Quality Policy		YES / NO
9.4	Site Plan		YES / NO
9.5	Manufacturing Flowchart		YES / NO
	Completed by:		Date:
	Signature/s:
	Designation: Department: QA

ALSO READ: SOP for Vendor Qualification and Management