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Production Process Audit Checklist

Production Process Audit Checklist

The audit scope of the Production Process is observing and evaluating following elements of the Quality Management System, such as: planning of product realization, infrastructure and work environment, identification and traceability, customer property management, availability of necessary work instructions, existence of specific methods and procedures, monitoring and measurement of product and process, control of non-conforming product and control of records.

You have to observe following standards:

1. ISO Standard 4.2.1 Documentation Requirements

The Quality Management System documentation shall include:

  1. documented statements of a Quality Policy and quality objectives,
  2. a Quality Manual,
  3. documented procedures like internal procedures which are established, documented, implemented and maintained and related records required, and
  4. documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

2. ISO Standard 4.2.2 Quality Manual

The organization shall establish and maintain a Quality Manual that includes:

  1. the scope of the Quality Management System, including details of and justification for any exclusions;
  2. the documented procedures established for the Quality Management System, or reference to them, and
  3. a description of the interaction between the processes of the Quality Management System.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

3. ISO Standard 4.2.3 Control of Documents

Documents required by the Quality Management System shall be controlled by following procedure which address:

  1. approval of documents for adequacy prior to issue,
  2. reviewing and updating as necessary and re-approval of documents,
  3. ensuring that changes and the current revision status of documents are identified,
  4. ensuring that relevant versions of applicable documents are available at points of use,
  5. ensuring that documents remain legible and readily identifiable,
  6. ensuring that documents of external origin determined by the organization to be necessary for the planning and operation of the Quality Management System are identified and their distribution controlled, and
  7. prevention of the unintended use of obsolete documents, or to apply suitable identification to them if they are retained for any purpose.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

4. ISO Standard 4.2.4 Control of Records

Records established to provide evidence of conformity to requirements and of the effective operation of the Quality Management System shall be controlled by following procedure which defines the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.

Records shall remain legible, readily identifiable and retrievable.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

5. ISO Standard 6.4 Work Environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements which relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).

Reference / Remarks:

Conformity YES / NO / Not applicable: 

6. ISO Standard 7.1 Planning of Product Realization

The organization’s planning process shall be consistent with the requirements of the other processes of the Quality Management System the organization shall determine the following:

  1. quality objectives and requirements for the product;
  2. the need to establish processes and documents, and to provide resources specific to the product;
  3. required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
  4. records needed to provide evidence that the realization processes and resulting product meet requirements.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

7. ISO Standard 7.4.1 Purchasing Process

The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established.

Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

8. ISO Standard 7.4.2 Purchasing Information

The requirement is that the purchasing information shall describe the product to be purchased, including, where appropriate:

  1. requirements for approval of product, procedures, processes and equipment,
  2. requirements for qualification of personnel, and
  3. Quality Management System requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

9. ISO Standard 7.4.3 Verification of Purchased Product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

10. ISO Standard 7.5.1 Control of Production and Service Provision

The organization shall plan and carry out production and service provision under controlled conditions.

Controlled conditions shall include, as applicable:

  1. the availability of information that describes the characteristics of the product,
  2. the availability of work instructions, as necessary,
  3. the use of suitable equipment,
  4. the availability and use of monitoring and measuring equipment,
  5. the implementation of monitoring and measurement, and
  6. the implementation of product release, delivery and post-delivery activities.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

11. ISO Standard 7.5.2 Validation of Processes for Production and Service Provision

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to achieve planned results.

The organization shall establish arrangements for these processes including, as applicable,

  1. defined criteria for review and approval of the processes,
  2. approval of equipment and qualification of personnel,
  3. use of specific methods and procedures,
  4. requirements for records, and
  5. re-validation

Reference / Remarks:

Conformity YES / NO / Not applicable:

12. ISO Standard 7.5.3 Identification and Traceability

The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.

Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

13. ISO Standard 7.5.4 Customer Property

The organization shall exercise care with customer property (including intellectual property and personal data) while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

14. ISO Standard 7.5.5 Preservation of Product

The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

15. ISO Standard 7.6 Control of Monitoring and Measuring Equipment

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment shall

  1. be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
  2. be adjusted or re-adjusted as necessary;
  3. have identification in order to determine its calibration status;
  4. be safeguarded from adjustments that would invalidate the measurement result;
  5. be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

16. ISO Standard 8.3 Control of Non-Conforming Product

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.

A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with non-conforming product.

Where applicable, the organization shall deal with non-conforming product by one or more of the following ways:

  1. by taking action to eliminate the detected non-conformity;
  2. by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
  3. by taking action to preclude its original intended use or application;
  4. by taking action appropriate to the effects, or potential effects, of the non-conformity when non-conforming product is detected after delivery or use has started.

When non-conforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

Records of the nature of non-conformity and any subsequent actions taken, including concessions obtained, shall be maintained.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

17. ISO Standard 8.4 Analysis of Data

The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the Quality Management System and to evaluate where continual improvement of the effectiveness of the Quality Management System can be made.

This shall include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data shall provide information relating to:

  • customer satisfaction,
  • conformity to product requirements,
  • characteristics and trends of processes and products, including opportunities for preventive action,
  • and suppliers.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

18. ISO Standard 8.5.1 Continual Improvement

The organization shall continually improve the effectiveness of the Quality Management System through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

19. ISO Standard 8.5.2 Corrective Action

The organization shall take action to eliminate the causes of nonconformity in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformity encountered.

A documented procedure shall be established to define requirements for:

  1. reviewing nonconformity (including customer complaints),
  2. determining the causes of nonconformity,
  3. evaluating the need for action to ensure that nonconformity do not recur,
  4. determining and implementing action needed,
  5. records of the results of action taken,
  6. and reviewing the effectiveness of the corrective action taken.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

20. ISO Standard 8.5.3 Preventive Action

The organization shall determine action to eliminate the causes of potential nonconformity in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements for:

  1. determining potential nonconformity and their causes,
  2. evaluating the need for action to prevent occurrence of nonconformity,
  3. determining and implementing action needed,
  4. records of results of action taken,
  5. and reviewing the effectiveness of the preventive action taken.

Reference / Remarks:

Conformity YES / NO / Not applicable: 

Do not forget, you must have a system which is proved in practice and shall be continuously updated according the company’s needs and customer’s requirements.

4 Your-Quality is not a website where you can simply download all your documents for implementation. You will find here effective techniques which enable you to setup your local procedures based on industry standards and best practice.

Want to know more? Please check following subjects:

Management Policy Statement

Safety and Security Policy

Unscheduled Audits and Inspections

Customer Relationship Management

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