IA Catchwords– Series 10

Outsourced processes control

Process outsourcing has been considered to be an extended arm of any organization, in view of specializations that have set in the various industries. Those processes are well knit in any company’s product/service profile.

Hence, auditing an outsourcing process, is as good and important as any the running processes

The following requirements are to be ensured while auditing outsourced processes

·         Identification of those processes/activities in the Quality Manual

·         Identification of the outsourced process stages, as an integral part of the overall product/service realization – either as a process realization flow or as a quality /process plan

·         Identification of scope of each of those processes, with respect to the products/services rendered by the company

·         Scope shall include list of activities to be carried out by the outsourced agency, and records to be maintained

·         Establishment of control mechanisms to each one of those processes, shall be defined and documented

·         Control mechanism shall to include the 5W and 1H and the applicable QMS clause numbers- activity wise

·         Controls shall include pre-qualification, periodic monitoring & controlling, and re-evaluation

·         Records of the controls shall focus on the process outputs- stage wise, and in line with the requirements of the QMS

·         Controls shall be comprehensive and to include the QMS processes which are common to all the processes, such as control of documents, control of records, defining responsibilities & authorities, control of NC products, etc.,

·         Controls shall include maintenance of records, including the monitoring & control of the processes

·         Control shall include Internal Auditing of the processes, including planning, scheduling, conducting, recording, and follow up of the processes

·         Management review shall include the results of the outsourced processes , with decisions and actions