Training Module
Training Module

Production Control

Understand ISO 9001 requirements for controlled production conditions, identification and traceability, preservation, and control of production changes

Understand

Implement

Manage

Audit

Training module overview

Many ISO 9001 implementations document production procedures and work instructions, but control breaks down in practice: criteria are unclear at the point of use, process changes happen informally, traceability is partial, and “release” becomes a paperwork step instead of an operational decision. The result is variation, rework, customer escapes, and fragile audit evidence.

This standard-specific specialisation module translates ISO 9001 production control requirements into a practical control set for manufacturing and similar production environments. It focuses on controlled conditions, special processes, identification and traceability, preservation and handling, and disciplined control of production changes and status. Boundaries: it does not cover customer requirements translation, service provision controls, or product/service design and development (handled in the respective ISO 9001 specialisation modules), and it does not re-teach generic methods (risk methodology, documented information architecture, monitoring system design, corrective action mechanics, or audit craft).

Many ISO 9001 implementations document production procedures and work instructions, but control breaks down in practice: criteria are unclear at the point of use, process changes happen informally, traceability is partial, and “release” becomes a paperwork step instead of an operational decision. The result is variation, rework, customer escapes, and fragile audit evidence.

This standard-specific specialisation module translates ISO 9001 production control requirements into a practical control set for manufacturing and similar production environments. It focuses on controlled conditions, special processes, identification and traceability, preservation and handling, and disciplined control of production changes and status. Boundaries: it does not cover customer requirements translation, service provision controls, or product/service design and development (handled in the respective ISO 9001 specialisation modules), and it does not re-teach generic methods (risk methodology, documented information architecture, monitoring system design, corrective action mechanics, or audit craft).

Target audience

  • Quality managers and ISO 9001 management system implementers working with production teams

  • Production / operations managers accountable for stable execution and output conformity

  • Process owners and supervisors responsible for work instructions, setups, and shift handovers

  • Engineering, industrialisation, and manufacturing support roles involved in process changes and validations

  • Internal stakeholders preparing production areas for readiness or effectiveness reviews (manager-side)

  • Quality managers and ISO 9001 management system implementers working with production teams

  • Production / operations managers accountable for stable execution and output conformity

  • Process owners and supervisors responsible for work instructions, setups, and shift handovers

  • Engineering, industrialisation, and manufacturing support roles involved in process changes and validations

  • Internal stakeholders preparing production areas for readiness or effectiveness reviews (manager-side)

Agenda

ISO 9001 production control—what it actually requires in production

  • Controlled conditions and “status control” at the point of work

  • Scope boundaries vs. requirements, service provision, and design & development

Controlled conditions in practice

  • Work instructions, acceptance criteria, and “right-first-time” information at the workplace

  • Equipment, environment, tooling, and verification activities as part of control (not add-ons)

People-side control without re-teaching HR systems

  • Competence and role clarity as production controls (who can set up, approve, release, rework)

  • Shift handovers, communication routines, and escalation triggers (manager-side expectations)

Special processes and validation logic (ISO 9001 application)

  • Recognising special processes (where outputs can’t be fully verified later)

  • What validation evidence typically looks like (parameters, qualifications, re-validation triggers)

Identification, traceability, and preservation

  • Identification and traceability decisions: what must be traceable, to what depth, and why

  • Preservation in real terms: handling, packaging, storage, and protection of customer property (where applicable)

Control of production changes

  • What counts as a “production change” and why informal change is a system failure mode

  • Change controls that work on the shop floor: authorisation, verification, communication, and traceable status

Release and nonconforming outputs at production level

  • Practical release controls: criteria, authority, and evidence at the time of release

  • Containment, segregation, concession logic, and disposition records (without re-teaching corrective action systems)

Workshop (case-based)

  • Build a production control pack for a Halderstone case (controls, roles, records, and change triggers)

  • Optional: map one participant’s own production area as an individual exercise (for in-house deliveries)

ISO 9001 production control—what it actually requires in production

  • Controlled conditions and “status control” at the point of work

  • Scope boundaries vs. requirements, service provision, and design & development

Controlled conditions in practice

  • Work instructions, acceptance criteria, and “right-first-time” information at the workplace

  • Equipment, environment, tooling, and verification activities as part of control (not add-ons)

People-side control without re-teaching HR systems

  • Competence and role clarity as production controls (who can set up, approve, release, rework)

  • Shift handovers, communication routines, and escalation triggers (manager-side expectations)

Special processes and validation logic (ISO 9001 application)

  • Recognising special processes (where outputs can’t be fully verified later)

  • What validation evidence typically looks like (parameters, qualifications, re-validation triggers)

Identification, traceability, and preservation

  • Identification and traceability decisions: what must be traceable, to what depth, and why

  • Preservation in real terms: handling, packaging, storage, and protection of customer property (where applicable)

Control of production changes

  • What counts as a “production change” and why informal change is a system failure mode

  • Change controls that work on the shop floor: authorisation, verification, communication, and traceable status

Release and nonconforming outputs at production level

  • Practical release controls: criteria, authority, and evidence at the time of release

  • Containment, segregation, concession logic, and disposition records (without re-teaching corrective action systems)

Workshop (case-based)

  • Build a production control pack for a Halderstone case (controls, roles, records, and change triggers)

  • Optional: map one participant’s own production area as an individual exercise (for in-house deliveries)

Course ID:

HAM-PC-1

Audience:

Manager

Domain:

Quality

Available in:

English

Duration:

7 h

List price:

CHF 550

Excl. VAT. VAT may apply depending on customer location and status.

What you get

Learning outcomes

  • Interpret ISO 9001 production control requirements into specific, runnable shop-floor controls (criteria, roles, records)

  • Define “controlled conditions” for a production process and identify typical gaps that cause variation and weak evidence

  • Determine when a process is a special process and specify fit-for-purpose validation evidence and re-validation triggers

  • Design a traceability approach (scope and depth) that matches product, risk, and operational reality—without overbuilding

  • Implement practical preservation controls across handling, packaging, storage, and customer-supplied items (where relevant)

  • Set up a disciplined production change control routine that prevents informal changes and supports stable output

  • Establish production-level release and nonconforming output controls that support fast containment and clear decisions

  • Interpret ISO 9001 production control requirements into specific, runnable shop-floor controls (criteria, roles, records)

  • Define “controlled conditions” for a production process and identify typical gaps that cause variation and weak evidence

  • Determine when a process is a special process and specify fit-for-purpose validation evidence and re-validation triggers

  • Design a traceability approach (scope and depth) that matches product, risk, and operational reality—without overbuilding

  • Implement practical preservation controls across handling, packaging, storage, and customer-supplied items (where relevant)

  • Set up a disciplined production change control routine that prevents informal changes and supports stable output

  • Establish production-level release and nonconforming output controls that support fast containment and clear decisions

Learning materials

  • Slide deck

  • Participant workbook

  • Certificate of completion

  • Slide deck

  • Participant workbook

  • Certificate of completion

Templates & tools

  • Production control pack outline (controlled conditions, roles, criteria, records)

  • Shop-floor “controlled conditions” checklist (point-of-use readiness)

  • Special process identification and validation record template (incl. re-validation triggers)

  • Identification & traceability design sheet (levels, links, retention, practical constraints)

  • Preservation & customer property checklist (handling, packaging, storage, protection)

  • Production change control log and communication checklist (authorisation, verification, status)

  • Optional AI prompt set for deviation clustering and handover summarisation (supporting judgement, not replacing it)

  • Production control pack outline (controlled conditions, roles, criteria, records)

  • Shop-floor “controlled conditions” checklist (point-of-use readiness)

  • Special process identification and validation record template (incl. re-validation triggers)

  • Identification & traceability design sheet (levels, links, retention, practical constraints)

  • Preservation & customer property checklist (handling, packaging, storage, protection)

  • Production change control log and communication checklist (authorisation, verification, status)

  • Optional AI prompt set for deviation clustering and handover summarisation (supporting judgement, not replacing it)

Prerequisites

This module assumes general familiarity with ISO 9001 management system concepts and basic process thinking. Participants should be comfortable discussing:

  • How processes are defined, owned, and controlled in daily operations

  • The difference between criteria, verification, and evidence in production contexts

  • Basic documented information handling (using and maintaining controlled instructions and records)

This module assumes general familiarity with ISO 9001 management system concepts and basic process thinking. Participants should be comfortable discussing:

  • How processes are defined, owned, and controlled in daily operations

  • The difference between criteria, verification, and evidence in production contexts

  • Basic documented information handling (using and maintaining controlled instructions and records)

Strongly recommended preparatory modules

Risk Management Foundations: Consistent Risk and Opportunity Logic Across Management Systems

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Risk Management Foundations: Consistent Risk and Opportunity Logic Across Management Systems

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Documentation & Knowledge Foundations: Documented Information, Records, and Organisational Knowledge

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Documentation & Knowledge Foundations: Documented Information, Records, and Organisational Knowledge

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Helpful preparatory modules

The modules below prepare for an optimal learning experience – but are not strictly necessary for participants to follow.

System Foundations: Context, Stakeholders, and System Boundaries

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System Foundations: Context, Stakeholders, and System Boundaries

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Fundamentals of documented information control, records, and knowledge capture for management systems

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Office scene with people standing, walking and sitting

Ready to achieve mastery?

Bring ISO requirements into everyday practice to reduce avoidable issues and strengthen the trust of your customers and stakeholders.

Office scene with people standing, walking and sitting

Ready to achieve mastery?

Bring ISO requirements into everyday practice to reduce avoidable issues and strengthen the trust of your customers and stakeholders.

Office scene with people standing, walking and sitting

Ready to achieve mastery?

Bring ISO requirements into everyday practice to reduce avoidable issues and strengthen the trust of your customers and stakeholders.