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Operational Planning and Control

Procedure

Document Control
Document Number: QMS-PRO-011
Version Number: 1
Review Date: Insert Date
Next Review: Insert Date
Prepared by: Insert name / position

Version History
Version Date Author Approved By Brief Description of Changes
1 Insert Date Insert name / Insert name / Describe changes that were
position position made to document in order to
qualify changing the version.
 QMS-PRO-011 Operational Planning and Control Procedure (D&D)

1. Purpose
The purpose of this procedure is to establish the method for the operational planning and control of
the processes within the Quality Management System based on the requirements of the ISO
9001:2015 Standards.

Insert Company Name will plan, implement and control processes within the Quality Management
System, and the Organization needed to meet the requirements for the provision of product and
services, and to implement the actions determined within the Risk Assessment.

2. Scope
This procedure is applicable to the Quality Management System and all relevant policies, procedures
and/or processes within the Company.

3. Reference
• ISO 9001:2015 Standard, Clause 8.1

4. Associated Documents
• QMS-PRO-018 Non-conformance and Corrective Action Procedure
• QMS-PRO-012 Management of Change Procedure

5. Responsibility
The Management Quality Representative, along with the Operations Team are responsible for
ensuring this procedure is effectively implemented and carried out in accordance to all relevant
product and Client requirements.

6. Definitions
QMS
Quality Management System

Product
“Product” includes:
• Deliverable reports, client drawings or relevant documents

7. Client Communication
Communication with Clients shall be conducted to ensure the smoothness of the following process:
• Providing information relating to products and services; during tendering / bidding process
• Handling enquiries, contracts or orders, including changes;
• Obtaining Client feedback relating to products and services, whenever Client complaints are
received, the solution process shall follow in accordance to the Non-conformance and
Corrective Action Procedure

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 QMS-PRO-011 Operational Planning and Control Procedure (D&D)

• Handling or controlling Client property, if applicable

• Establishing specific requirements for contingency actions, when relevant.
Client communication generally occurs to establish their order requirements, including drawings,
specifications and, when applicable, installation instructions.

This process takes into consideration subsequent changes to their requirements by Clients, as well as
any which are initiated by Insert Company Name.

When problems arise during the order, the relevant Managers must inform the Insert Responsible
Person that any anticipated delays in delivering the required services is communicated to the Client
as soon as possible.

All the relevant resources are in place to communicate effectively with the Client in relation to:
• Service and product information
• Enquiries, contracts, amendments of contracts
• Client feedback including Client complaints.

8. Determining the Requirements of Products and Services

When determining the requirements for the products and services to be offered to the Clients, the
designated person shall ensure that:
• the requirements for the products and services as defined in the Contract Document /
Purchase Order, including:
➢ any applicable statutory and regulatory requirements
➢ those considered necessary by the Company
• The Company can meet the claims for the products and services it offers as defined in the
Contract Document / Purchase Order.

Enquiries and Orders are recorded and evaluated, generally in discussion with the Clients, to ascertain
their complete requirements and ensuring the Company’s capability to meet these requirements,
before planning and commencing service.

This process includes identification and attention to any statutory and regulatory requirements
relating to the products.

Changes to ordering instructions are documented and confirmed with the Clients, before
implementation.

Insert Company Name ensures that it can meet the requirements for products and services to be
offered to Clients. Insert Company Name shall conduct a review before committing to supply products
and services to a Client, to include:
• Requirements specified by the Client, including the requirements for delivery and post-
delivery activities
• Requirements not stated by the Client, but necessary for the specified or intended use, when
known
• Requirements specified by the Company
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 QMS-PRO-011 Operational Planning and Control Procedure (D&D)

• Statutory and regulatory requirements applicable to the products and services and
• Contracts or Order requirements differing from those previously expressed

Insert Company Name reviews the following documents:

• Technical scope of work and terms of reference specified
• Cost estimate; and
• Client specifications.

9. Design and Development of Products and Services

Planning
All inputs required for the design and development are collected from relevant Clients.

Insert Company Name plans and schedules the design and development stages as part of the control
purposes.

Upon confirmation of scope of work by the Client, the following design criteria are followed:
• Client brief
• Client requirements
• Cost estimates
• Application from Client
• Purchase order and
• Any regulatory and legal requirements.

The above inputs are reviewed for adequacy. Any clarifications from the inputs are discussed with the
Clients to avoid ambiguity.

Design and development outputs include:

• Design Drawing
• Invoicing
• Plan
• Budget.

The design and development outputs are verified in accordance with design and development inputs
prior to release.

10. Design and Development Review

The Design and development reviews form part of the review stage defined by either Insert
Company Name or Clients based on the requirements of the initial brief. In case of outsourcing,
Insert Company Name does the follow up with the Supplier to ensure that services are executed in
time, these requirements are stipulated within the Supplier Agreement.

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 QMS-PRO-011 Operational Planning and Control Procedure (D&D)

11. Design and Development Verification and Validation

The verification is performed in accordance with planned arrangement to ensure that the design
and development output have met the design and development input requirements.

The design and development validation activities include the inspection and quality assurance of
activities such as:
• Obtained approvals, where appropriate
• Process Control
• The quality assurance is carried out per process.

12. Design and Development Changes

The design and development changes are established during the design reviews, and actions are
taken accordingly. Client approvals are obtained based on the specified requirements. The
modifications are not executed without the approval of Management. Changes will be actioned in
accordance to the Management of Change Procedure dependent on the nature of change.

13. Control of Externally Provided Processes, Products and Services

Insert Company Name ensures that externally provided processes, products and services conform to
all relevant requirements.

Control of externally provided processes include:

• Determination of purchasing control including selection, evaluation, re-evaluation and
monitoring of External Provider (Supplier)
• Type and extent of control of purchasing process and
• Effective communication to the External Provider (Supplier).

Purchase Orders specify the requirements completely and are the criteria for receiving inspection.

All incoming materials are checked for conformance, and records are kept of Supplier Performance to
provide feedback information. Regular communications are maintained with Suppliers to ensure good
service and to motivate quality improvement.

14. Control of Products and Services provided by Insert Company Name

The processes employed in the fulfilment of Clients’ orders are essentially standard for the types of
product manufactured by Insert Company Name Consequently, the Company is unlikely to develop
and introduce new processes for each order.

However, if the requirements for an Order are beyond the Company’s capability, such work may be
sub-contracted to specialist organisations.

The necessary equipment and work instructions have been evaluated and approved by Top
Management as being suitable for technical and quality requirements. These include inspection
instruments with the relevant instructions and criteria.

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 QMS-PRO-011 Operational Planning and Control Procedure (D&D)

Administrative processes which have been established and approved by Management, may be
upgraded as and when it is found necessary.

15. Identification and Traceability

Insert Company Name identifies the service status with respect to monitoring and measurement
requirements throughout project realisation. Where traceability is a requirement Insert Company
Name’ controls the unique identification of the project and maintain records thereof.

For the methods of identifying nonconforming product, refer to Control of Non-conformance and
Corrective Action Procedure.

Service Deliverables
Service deliverables, such as reports and schedules, shall be identified with a title and, if applicable,
reference to the Order under which they are developed.

Client contracts may indicate additional methods for identification of service deliverables. In all cases,
the deliverable will be identified in a way that makes it clearly understood for which Order the
deliverable is subject to.

As required, service deliverables may be subject to date and revision control, to distinguish earlier
versions or submittals.

16. Release of Products and Services

Insert Company Name implements planned arrangements, at appropriate stages, to verify that the
product and/or service requirements have been met. The release of products and/or services to the
Client will not proceed until the planned arrangements have been satisfactorily completed in
accordance.

If a product and/or service has not been delivered in accordance to the Client’s requirements, the
Non-conformance and Corrective Action Procedure should be followed. The record of a released
product and/or service shall be retained to ensure:
• Evidence of conformity with the acceptance criteria
• Traceability to the person(s) authorising the release

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