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New Work Item Proposal 65A-1207 ED1: Batch control - Part 0: Life cycle model for Batch Control

Source:
IEC
Committee:
GEL/65/1 - Systems aspects
Categories:
Information management | Standardization. General rules
Comment period start date:
Comment period end date:

Comment by:

Scope

The proposed NP for Part 0 of IEC 61512 applies to systems, specifications, and their use for implementing batch control and related procedure-oriented manufacturing controls. This document will define a common terminology for and define work processes for a sustainable and agile life cycle model for batch control. Key proposed work processes include a batch control philosophy, batch control design strategies, batch control implementation, batch control exception handling methodology, batch control monitoring and assessment, and a batch control audit processes.

This Part 0 will reference the Models and Terminology Part 1, Data structures and guidelines for languages of Part 2, General and site recipe models and representation of Part 3 and the Batch production records of Part 4.

This document will provide:

- a batch control philosophy, the adopt good engineering principles for localized batch control strategies

- batch control design principles

- batch control testing and training requirements as part of the implementation of the defined batch control philosophy

- principles for batch control operation, maintenance and management of change

- principles for batch control performance monitoring and assessment

- requirements for batch control audits and updates to the batch control philosophy Requirements for risk assessment and process safety are excluded from the scope of this document. Relations to alarm and HMI management standards will be defined.

Purpose

The other parts of the IEC 61512 series of standards were developed without reference to a life cycle model. The life cycle model brings coherent structure for batch manufacturing automation and control. The targeted batch control philosophy will provide end-users an agile way to structure the work processes to the needs and constraints of the plant. Batch manufacturing differs from highly automated (lights out or unsupervised operations) to very manually intensive. The Batch Control Philosophy will reflect such wide variations in a structured way.

Defining work processes is of essence to establish workflows in the organisation and the requirements of information exchange between these work processes. This will increase interoperability and further digitalization.

This part of the standard acts as the foundational reference for implementers, auditors, and stakeholders, guiding the application of the standard in a structured and lifecycle-aware manner.

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