QM: 7.2 Customer Related Processes (7.2.1, 7.2.2 & 7.2.3)

Customer-related processes

Introduction

ISO 9000 defines customer as an organization or person that receives a product or service and includes purchaser, consumer, client, end user, retailer, beneficiary and purchaser.

A customer can be internal or external to the organization.

Customers are stakeholders: they have entered into a commitment in return for some benefits that possession of a product or experience of a service may bring. Customers demand, request or otherwise place an organization under a commitment, implying that there is no such thing as an internal customer.

The customer is often thought of as the person who buys a product or service but, in the above definition, this is a customer who is a purchaser. The end user may not buy the product but is the person for whom the product or service is produced.

To understand the requirements of the clause it is important to identify the customers to the product.

The customer of the pharma/biopharma product are end user (consumer), regulatory agencies (for end user and for benefit of end user), stockiest, distributor, retailer, pharmacist, health care staff etc.

7.2	CUSTOMER RELATED PROCESSES
7.2.1	Determination of Requirements Related to Product
7.2.2	Review of Requirements Related to Product
7.2.3	Customer Communication

7.2 Customer-related processes

7.2.1  Determination of requirements related to product

The company’s prime focus is to reach out for the customers, understanding their environment and identifying solutions suitable to their needs and applications, which will both meet and exceed their expectations. The company focuses on innovations to provide quality product at competitive price thus providing health to all.

Requirements related to the product have been determined by the organization during the developmental stage and reviewed at regular interval for compliance with customer and regulatory requirements. Other requirements related to product which are determined, include:

• Requirements specified by customers (distribution companies, retailers, health care staff), including the requirements for products type and quantity and delivery time, transportation and storage control. All inquiries / tenders are carefully studied, before quoting, to identify that all requirements are adequately defined and there is no requirement which is beyond organization’s capability in terms of capability, specifications, delivery schedule etc. The orders are accepted only if the organization can meet the commitments and customer’s requirement. Any post delivery activity not identified during product realization are clarified and addressed before commitment to supply.

• Requirements not stated by the customer but necessary for intended use of the products such as requirements for unit pack configuration/packaging and instructions for safe use/administration, instruction for disposal. Such requirements once identified are clarified and agreed with before delivery.

• Statutory and regulatory requirements related to the product including the requirement stated in pharmacopeias or determined by National Regulatory Authority. These requirements are stated in manufacturing and testing plans.

• Organizational requirements and requirements stated by commercial partners. These requirements are clarified and incorporated prior to execution of the order and delivery of the products.

7.2.2 Review of Requirements Related to the Product

After the requirements related to product are determined and defined a formal review of all the requirements related to product is performed together with additional requirements that are not specified but are necessary for fitness for use and governed by laws and regulations, and requirements for availability, delivery, and support. The review is conducted to establish and maintain customer satisfaction before commitment to supply a product to the customer. The review ensures that: 

• Product requirements (including requirements related to delivery and post-delivery activities) are defined
• Special requirements of the product are determined
• Contract or order requirements differing from those previously expressed are resolved
• The organization has the resources, ability, capability and capacity to meet the requirements of the order / contract.
• Risks (e.g., short delivery time) have been identified

Records of the results of review and actions arising from this review are maintained.

When product requirements are changed, relevant documents are amended and the relevant personnel are made aware of the changed requirements. Documents for such changes are updated.

7.2.3 Customer Communication

Communications may address information related to product, inquiries, contracts, contract amendments, order handling, complaints, and advisory notices / recalls. Required arrangements for communication with customers relating to the followings are determined and implemented: 

·      Product information according to the customer communication procedure

·      Customers can contact the organization via phone, e-mail, fax and mail.

·      Enquiries, contracts or order handling, according to the sales procedure

·      Customer feedback, according to the customer communication procedure.

·      Enquiries, contracts and order handling, including amendments etc. are handled effectively.

      

Customer complaints are handled by Quality Department through the Sales Department. Customer feedback and complaints are classified into categories to allow for better tracking of trends and evaluating improvement in specific aspects (complaints follow-up procedure). Every complaint is communicated to relevant functions within and outside the organization. When appropriate, Quality Assurance may be requested to initiate corrective or preventive actions. When product recall is necessary, this process will be handled according to the product recall procedure.