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Quality and Process Management > Clause 8 : "Operation" > Flashcards

Clause 8 : "Operation" Flashcards

1
Q

Operational planning and control (1)

A

The organization shall plan, implement and control
the processes needed to meet the requirements for the provision of products and services by determining the requirements for the products and services;
- establishing criteria for the processes;
- establishing criteria for the acceptance of products and
services;
- implementing control of the processes in accordance with the criteria;
- determining, maintaining and retaining documented information
- to have confidence that the processes have been carried out as planned;
- to demonstrate the conformity of products and services to their requirements

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2
Q

Operational planning and control (2)

A

The output of this planning shall be suitable for the
organization‘s operations.
The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
The organization shall ensure that outsourced processes are controlled!

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3
Q

Requirements for products and services – Customer communication

A

Communication with customers shall include:
- providing information relating to products and
services;
- handling enquiries, contracts or orders, including
changes;
- obtaining customer feedback relating to products and
services, including customer complaints;
- handling or controlling customer property;
- establishing specific requirements for contingency actions, when relevant.

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4
Q

Requirements for products and services – Determining the requirements for products and services

A

When determining the requirements for the products and services to be offered to customers, the organization shall ensure that

  • the requirements for the products and services are defined, including any applicable statutory and regulatory requirements and those considered necessary by the organization;
  • the organization can meet the claims for the products and services it offers.
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5
Q

Requirements for products and services – Review of the requirements for products and services (1)

A

The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, to include:

  • requirements specified by the customer;
  • requirements for delivery and post-delivery activities;
  • requirements not stated by the customer, but necessary for the specified or intended use, when known;
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6
Q

Requirements for products and services – Review of the requirements for products and services (2)

A
  • requirements specified by the organization;
  • statutory and regulatory requirements;
  • contract or order requirements differing from those previously expressed.
    The organization shall ensure that contract or order requirements differing from those previously defined are resolved. The organization shall retain documented information, as applicable, on the results of the review and on any new requirements.
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7
Q

Requirements for products and services – Changes to requirements for products and services

A

The organization shall ensure that
n relevant documented information is amended, and
n that relevant persons are made aware of the changed requirements,
when the requirements for products and services are changed

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8
Q

Design and development of products and services – General

A

The organization shall establish, implement and maintain,

a design and development process that is appropriate to ensure the subsequent provision of products and services.

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9
Q

Design and development of products and services – Design and development planning (1)

A

The organization shall determine the stages and controls for design and development.
In this respect, it shall be considered:
- the nature, duration and complexity of the design and
development activities;
- the required process stages including applicable design
and development reviews;
- the required verification and validation activities;
- the responsibilities and authorities involved in the design and development process;

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10
Q

Design and development of products and services – Design and development planning

A
  • the internal and external resource needs for the design and development of products and services;
  • the need to control interfaces between persons involved in the design and development process;
  • the need for involvement of customers and users in the design and development process;
  • the requirements for subsequent provision of products and services;
  • the level of control expected for the design and development process by customers and other relevant interested parties;
  • the documented information needed to demonstrate that design and development requirements have been met.
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11
Q

Design and development of products and services – Design and development inputs

A

The organization shall determine the requirements essential for the specific types of products and services to be designed and developed.
The organization shall consider:
- functional and performance requirements;
- information derived from previous similar design and development activities;
- statutory and regulatory requirements;
- standards or codes of practice that the organization has
committed to implement;
- potential consequences of failure due to the nature of the products and services.

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12
Q

What are the Development inputs?

A

Inputs shall be adequate for the design and development purposes, complete and unambiguous.
Conflicting design and development inputs shall be resolved.
The organization shall retain documented information on design and development inputs.

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13
Q

Why shall organization apply controls on the design?

A

The organization shall apply controls to the design and development process to ensure that:
- the results to be achieved are defined;
- reviews are conducted to evaluate the ability of the
results of design and development to meet requirements;
- verification activities are conducted to ensure that the design and development outputs meet the input requirements;
- validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use;
- any necessary actions are taken on problems determined during the reviews, or verification and validation activities;
- documented information of these activities is retained.

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14
Q

What shall the organization ensure that design output?

A

The organization shall ensure that design and development outputs:
- meet the inputs requirements;
- are adequate for the subsequent processes for the
provision of products and services;
- include or reference monitoring and measuring
requirements, as appropriate, and acceptance criteria;
- specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.
The organization shall retain documented information on design and development outputs.

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15
Q

What shall the organization do when design changes?

A

The organization shall identify, review and control
changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

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16
Q

Why shall the organization retail documented information?

A

The organization shall retain documented information on:

  • design and development changes,
  • the results of reviews,
  • the authorization of the changes,
  • the actions are taken to prevent adverse impact.
17
Q

When shall the organization determine the controls to be applied?

A
  • products and services from external providers are intended for incorporation into the organization owns products and services;
  • products and services are provided directly to the customer(s) by external providers on behalf of the organization;
  • a process, or part of a process is provided by an external provider as a result of a decision by the organization.
18
Q

What for shall the do organization apply criteria’s?

A

The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers.
The organization shall retain documented information of
these activities.

19
Q

What shall the organization ensure?

A

The organization shall ensure that externally provided processes, products and services do not adversely affect the organization‘s ability to consistently deliver conforming products and services to customers.
The organization shall ensure that externally provided processes remain within the control of its quality management system and define the controls that it intends to apply to an external
provider;
- define the controls that it intends to apply to the resulting output;
- take into consideration:
- the potential impact of the externally provided processes, products and services on the organization‘s ability to consistently meet customer and applicable statutory and regulatory requirements;
- the effectiveness of the controls applied by the external provider;
- determine the verification, or other activities, necessary to ensure that the externally provided processes, products, and services meet requirements.

20
Q

Why shall the organization communicate to external providers?

A

The organization shall communicate to external providers its requirements for:

  • the processes, products and services to be provided and the approval of
  • products and services;
  • methods, processes and equipment;
  • the release of products and services;
21
Q

What shall controlled conditions include?

A

the availability of documented information that defines

  • the characteristics of the products to be produced;
  • the characteristics of the services to be provided;
  • the characteristics of the activities to be performed;
  • the results to be achieved.
22
Q

What else shall controlled conditions include?

A
  • the availability and use of suitable monitoring and measuring resources;
  • the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services have been met;
  • the use of suitable infrastructure and environment for the operation of processes;
  • the appointment of competent persons, including any required qualification;
  • the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.
23
Q

How to identify and trace process outputs?

A
  • The organization shall use suitable means to identify process outputs (order number, ID number,…).
  • For this purpose, the status of outputs with respect to monitoring and measurement requirements shall be identified (unchecked, checked and released,…).
  • When traceability is a requirement, the organization shall retain the documented information necessary to enable traceability.
24
Q

How shall the organization protect external property?

A

The organization shall exercise care with property
belonging to customers or external providers.
The organization shall
- identify,
- verify,
- protect and - safeguard
customers’ or external providers’ property.
When their property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.

25
Q

How shall the organization preserve the outputs?

A 
The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.
Preservation can include:
- identification
- handling
- contamination control n packaging
- storage
- transportation
-...
26
Q

What shall the organization consider when meeting requirements for post delivery?

A
  • statutory and regulatory requirements;
  • the potential undesired consequences associated with its products and services;
  • the nature, use and intended lifetime of its products and services;
  • customer requirements; n customer feedback.
27
Q

When controlling what shall be in the documented information?

A
  • the results of the review of changes,
  • the person(s) authorizing the change, and
  • any necessary actions arising from the review.
28
Q

What shall the organization do when releasing products?

A

The organization shall
- implement planned arrangements,
- at appropriate stages,
- to verify
- that the product and service requirements have been met.
The release to the customer shall not proceed until
- the planned arrangements have been satisfactorily
completed;
- unless otherwise approved by a relevant authority and,
- as applicable, approved by the customer.

29
Q

What shall be in the documented information on the release of products?

A

The documented information shall include:

  • evidence of conformity with the acceptance criteria;
  • traceability to the person(s) authorizing the release.
30
Q

What shall be controlled concerning nonconforming outputs?

A

The organization shall ensure that outputs that do not
conform to their requirements are n identified and
- controlled
to prevent their
- unintended use or n delivery or
- provision .

31
Q

What are appropriate actions for nonconformity?

A

The organization shall take appropriate action based on
- the nature of the nonconformity and
- its effect on the conformity of products and services.
This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.

32
Q

How shall the organization deal with nonconforming outputs?

A

The organization shall deal with nonconforming outputs in one or more of the following ways:

  • correction (rework) and re-verification;
  • segregation, containment, return or suspension of provision of products and services;
  • informing the customer;
  • obtaining authorization for acceptance under concession.
33
Q

What shall be in the documented information regarding nonconformity?

A

The organization shall retain documented information that:

  • describes the nonconformity;
  • describes the actions taken;
  • describes any concessions obtained;
  • identifies the authority deciding the action in respect of the nonconformity.

Quality and Process Management (9 decks)

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