ISO 9001:2015 QMS Awareness – Performance evaluation – Monitoring, measurement, analysis and evaluation

ISO 9001:2015 QMS Awareness – Performance evaluation – Monitoring, measurement, analysis and evaluation

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Performance = Act of doing something

 

Performance = Measuring result

 

Performance can relate to – (i) Quantitative or qualitative findings, (ii) Management of activities, Management of processes, Products, Services, Systems, or Organizations.

 

Performance evaluation is a formal procedure to measure an activity, process, product, service, system or organization.

 

The organization needs to determine – (i) Monitoring and measurement needs (ii) Monitoring, measurement, analysis and evaluation methods, (Purpose – To ensure valid results), (iii) When to perform monitoring and measurement, (iv) When to perform analysis and evaluate the monitoring / measurement results, (v) Methods for obtaining, monitoring, and reviewing customers’ perception information.

 

Methods may include – Customer survey, Customer feedback, Customer meeting, Market-share analysis, Compliments, Warranty claims, Dealer report etc.

 

The organization needs to monitor / review / analyze / evaluate – (i) Quality management system performance and effectiveness, (ii) Customers’ perception information.

 

The organization needs to analyze and evaluate – Monitoring / measurement data / information.

 

It should be noted that statistical technique can be a method to analyze data. For guidance on statistical techniques for ISO 9001:2015 s, there is a standard document ISO 10017:2021 published by International Organization for Standardization (ISO) that provides guidelines for the selection of appropriate statistical techniques that can be useful to the organization, implementing ISO 9001:2015 QMS standard, irrespective of the organization’s size or complexity. Here is important for the organization to refer to ISO 10017:2021 as well as to provide awareness training on the use of statistical tools to its staff.

 

The organization needs to use analysis results and evaluate – (i) Product / service conformity, (ii) Customer satisfaction, (iii) Quality management system (QMS) performance and effectiveness, (iv) Planning implementation effectiveness, (v) Action’s effectiveness to address risks and opportunities, (vi) External providers’ performance, and (vii) quality management system improvement needs.

 

The organization needs to retain documented information (records) – Evidence of monitoring / measurement / analysis / evaluation results.

 

There is a need to understand the term ‘Quality management system (QMS) performance and effectiveness’ that refers to the assessment and measurement of the performance and effectiveness of the quality management system of the organization, which is a set of policies, processes and procedures implemented by the organization to ensure the its products or services consistently meet customer requirements and comply with applicable legal (statutory and regulatory) requirements.

 

The performance of a quality management system is evaluated by monitoring key performance indicators, such as customer satisfaction, product defects, process efficiency, compliance with standard’s requirements.

 

Quality management system effectiveness refers to the extent to which the system achieves its intended outcomes. It is a measure of how well the system is able to fulfil its purpose and deliver the desired results.

 

An effective quality management system (QMS) should demonstrate improvements in various areas, such as quality, customer satisfaction, overall performance etc. Assessing the performance and effectiveness of a quality management system (QMS) involves analyzing data, conducting audit, reviewing processes to identify areas of improvement. In short, we can say that the term ‘quality management system performance and effectiveness’ refer to the evaluation and measurement of how well the organization’s quality management system is performing in meeting quality objectives and delivering the desired outcomes for the organization.

 

Think of the following Questions

 

(1)   What is performance evaluation?

 

(2)   Why performance evaluation needed?

 

(3)   What are the requirements for performance evaluation of the quality management system?

 

(4)   What is the importance of statistical techniques?

 

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

 

ISO 9001:2015 QMS Awareness – Operation – Release of product / service, Control of nonconforming outputs

ISO 9001:2015 QMS Awareness – Operation – Release of product / service, Control of nonconforming outputs

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Release of product / service

 

Release = Permission to continue / go to the next stage of a process

 

Release = Permission to go to the next process

 

Release of product = Process of delivering of the product

 

Release of service = Process of delivering of the service

 

A product / service release is the process of delivering a product / service to the customer. But a release is much more than just the act of delivery. It involves ensuring that the product / service meets predetermined quality criteria and has undergone appropriate monitoring and measurement activities. For the customer (internal / external), it is a promise of added value. A product / service release signifies the completion of necessary activities and verification of conformity to specified requirements.

 

The organization needs to implement – Planned arrangements at appropriate stages. Purpose – To ascertain that the product / service requirements are met.

 

The organization needs to release product / service – Only when satisfying planned arrangement implementation or approval by a relevant authority / customer.

 

The organization needs to retain documented information (records) – Release of product / service and also (i) Conformity evidence with accepted criteria, (ii) Person traceability authorizing the release of the product / service.

 

Control of nonconforming output

 

Output = Result of a process

 

Nonconforming = Having nonconformity

 

Nonconformity = Non-fulfilment of a requirement

 

Nonconforming output = Result of a process that has nonconformity

 

The organization needs to ensure, identify and control – Nonconforming output (such result of a process that has nonconformity). Purpose – Prevent unintended use / delivery of nonconforming output.

 

The organization needs to take appropriate actions – Based on the nature of nonconformity and its effect on the product / service. This is also applicable to nonconforming product / service detected after delivery of product, during / after the provision of service.

 

The organization needs to deal with nonconforming outputs in suitable ways – Ways to deal (one or more) –

 

(i)              Correction of nonconforming output,

 

(ii)             Segregation of the nonconforming output,

 

(iii)            Containment of nonconformity,

 

(iv)           Return of nonconforming product / service,

 

(v)             Suspension of providing product / service,

 

(vi)           Informing the customer,

 

(vii)          Obtaining authorization for acceptance of the product / service under concession.

 

The organization needs to verify after correction – Product / service conformity to requirements.

 

The organization needs to retain documented information (records) – (i) Describing nonconformity of the output, (ii) Describing actions taken, (iii) Describing any concessions obtained, (iv) Identifying the authority deciding the action on nonconforming output.

 

A few examples of action to be taken may be as under –

 

(i)              If in a manufacturing process a resulting output is produced or manufactured with a defect, the correction involves reworking the output to rectify the defect and bring the nonconforming output into conformance with the required needs and expectations of the output,

 

(ii)             When some of the resulting outputs (goods / materials) are found to be damaged or nonconforming, such nonconforming goods / materials are separated from the conforming goods / materials and clearly marked or segregated to prevent unintended use or distribution of nonconforming goods / materials.

 

(iii)            If a nonconforming issue is identified in a particular manufacturing process, containment measures may involve stopping the manufacturing process in that line, quarantining the affected products, and preventing further distribution until the cause of nonconformity is determined and appropriate corrective actions are implemented.

 

(iv)           If a customer receives a defective or nonconforming product, the organization may arrange for its return and provide a replacement (conforming product) or refund.

 

(v)             If an organization finds or discovers a critical flaw in its system or process, the organization may temporarily suspend providing the product / service until the issue is resolved.

 

(vi)           If a nonconformity is identified in a product / service delivered to a customer, the organization promptly communicates the nonconforming issue to the customer including the nature of nonconformity and any necessary action being taken to resolve it.

 

(vii)          There may be situations where a nonconforming product / service cannot be turned into full compliance with the specified requirements, but the product / service may be acceptable for a specific purpose or with certain limitations. In such situations, the organization seeks customer approval or a concession to continue using or delivering the product / service while informing the nonconformity.  

 

Think of the following Questions

 

(1)   What is product / service release?

 

(2)   What is nonconformity?

 

(3)   What is nonconforming output?

 

(4)   How should an organization deal with nonconforming output?

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

 

ISO 9001:2015 QMS Awareness – Operation – Production and service provision

ISO 9001:2015 QMS Awareness – Operation – Production and service provision

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Production and service provision

 

Let us first understand, what is the meaning of production and service provision.

 

Production refers to the activities involved in manufacturing, assembling, and delivering a product. Production encompasses the transformation of inputs into tangible goods. Welding, painting, storing, handling, packaging etc are part of production activities.

 

Service provision refers to the activities involved in providing intangible services to a customer. It includes any process that contributes to the delivery of service, for example, providing analysis, coding, testing etc to the customer.

 

Production and service provision are critical elements of an organization’s operations and require effective execution, such as controlling resources, equipment, methods, processes, persons involved in operation activities.

 

Production and service provision also include identification, traceability, use of customer / external provider property, preservation, and post-delivery activities.

 

Controlled conditions are necessary to ensure that production and service provision consistently meet the organization and customer requirements.

 

Identification = The act of finding out who someone is or what something is = The act of identifying (recognizing) someone or something

 

Identification of product / component / equipment can be in the form of labels, tags, or markings.

 

Traceability = Ability to trace something as it moves through a process

 

Traceability = Ability to trace the history, application or location of an object.

 

Traceability can relate to – (i) the origin of materials and parts, (ii) the processing history, (iii) the distribution and location of the product / service after delivery.

 

Traceability is the ability to trace something as it moves through a process.

 

Control of production and service provision

 

The organization needs to implement – Production / service provision under controlled conditions.

 

Controlled conditions to include (as applicable):

 

(1)   Define in a documented information (and make its availability) – (i) Characteristics of product / service, (ii) Characteristics of activities to be performed, and (iii) Results to be achieved,

 

(2)   Availability and use of suitable monitoring / measuring resources,

 

(3)   Implementing monitoring / measurement activities at appropriate stages to verify meeting criteria of control (of process / output) and acceptance criteria for product / service,

 

(4)   Use of suitable infrastructure and environment for process operation,

 

(5)   Appointment of competent (and qualified) persons,

 

(6)   Validation and periodic re-validation of process ability to achieve planned result (where resulting output cannot be verified by subsequent monitoring / measurement,

 

(7)   Implementing actions (to prevent human error),

 

(8)   Implementing release / delivery / post-delivery activities.

 

Identification and Traceability

 

The organization needs to use suitable means to identify (recognize) outputs when required to ensure the product / service conformity.

 

The organization needs to identify (recognize) the output status (position) with respect to monitoring and measurement requirements.

 

The organization needs to control the unique identification of output, when traceability is a requirement.

 

Customers’ / External providers’ property

 

The organization needs to – (i) Exercise care while under the organization’s control or being used, (ii) Identify, verify, protect and safeguard, (iii) Report to the customer / external provider when such property is lost, damaged or otherwise noticed unsuitable for use.

 

Preservation

 

The organization needs to – Preserve outputs (to the extent necessary (to include identification, handling, contamination control, packaging, storage, transmission or protection) during production / service provision. Purpose – Ensure conformity to requirements.

 

Post-delivery activities

 

The organization needs to consider – (i) Legal requirements, (ii) Potential undesired consequences associated with the product / service, (iii) Customer requirements, (iv) Customer feedback, (v) Nature, use, and intended life of product / service.

 

The organization needs to determine – Post-delivery activities including warranty provisions, contractual obligations, such as maintenance, recycling / final disposal supplementary services.

 

The organization needs to meet requirements for post-delivery activities.

 

Control changes

 

The organization needs to review and control – Changes for product / service provision. Purpose – Continuing conformity with requirements.

 

Documented Information

 

The organization needs to retain documented information (records) – (i) Necessary to make sure traceability, (ii) What happened to customer / external provider property? (iii) Describing results of the review of changes, (iv) Describing personnel authorizing change, and (v) Describing any necessary actions arising from the review.

 

Think of the following Questions

 

(1)   What do you understand by production and service provision?

 

(2)   Is meeting traceability requirement always necessary?

 

(1)   What documented information you may need to retain for production and service provision?

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.

 

ISO 9001:2015 QMS Awareness – Operation – Control of externally provided processes, products and services

ISO 9001:2015 QMS Awareness – Operation – Control of externally provided processes, products and services

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Control of externally provided processes, products and services

 

Let us understand the terms ‘external provider’, ‘externally provided process’, ‘externally provided product’ and ‘externally provided service’.

 

Provider = Supplier = Contractor = A party, person or organization that provides a product or a service to the organization

 

A provider may be internal or external.

 

External provider = External supplier = A provider or supplier that is not part of the organization

 

Externally provided process = A process that is carried out by an external party, person or organization on behalf of the organization.

 

Externally provided product = A product that is provided by an external party, person or organization and used or incorporated into the organization’s own product/s or service/s. Raw material purchased from market is an externally provided product.  

 

Externally provided service = A service that is provided by an external party, person or organization to support the organization’s activities.

 

Examples of external provider – (i) Supplier of raw material, (ii) Supplier of components, (iii) Consulting organizations, (iv) Distributor, (v) Producer, (vi) Retailer, (vii) Vendor

 

Examples of externally provided process – (i) Calibration of testing equipment conducted by an external calibration laboratory, (ii) Information technology support provided by an external party, person or organization, (iii) Painting services outsourced to a professional painter, (iv) Employees’ trainings conducted by an external trainer or institute. 

 

Examples of externally provided product – (i) Raw material purchased from a supplier and used in the production of the organization’s product, (ii) Component purchased from a supplier and used in the production of the organization’s product, (iii) Software purchased from a software vendor and used in the organization’s systems, (iv) Safety equipment purchased from a supplier for use in the organization’s operation.

 

 

Examples of external provided service – (i) Consultation service provided by an external party, person or organization, (ii) Information technology services provided by an external party, person or organization.

 

Externally provided process / product / service may be through:

 

-        Purchasing from a supplier / vendor,

 

-        An arrangement with an associated organization,

 

-        Outsourcing process to an external provider.

 

Requirements

 

The organization needs to consider – (i) Potential impact of externally provided process / product / service on the organization’s ability to meet requirements (customer and legal), and (ii) Effectiveness of the controls applied by external providers.

 

The organization needs to determine – (i) Controls to be applied to the externally provided process / product / service, (ii) Criteria for evaluation, selection, performance monitoring and re-evaluation of external providers, (iii) Verification and other activities to ensure that externally provided process / product / service meets requirements. Clarification – It should be noted that controls to externally provided process / product / service are applicable (i) When product / service from the external provider is incorporated into the organization’s own product / service, (ii) When product / service is directly provided directly to the customer by the external provider on behalf of the organization, and (iii) When the organization decides to provide a process or part of a process by an external provider.

 

The organization needs to ensure – (i) Externally provided process / product / service conforms to requirements, (ii) Externally provided process / product / service does not adversely affect the organization’s ability to consistently deliver conforming product / service to customer, (iii) Externally provided process / product / service remain with the organization’s control, and (iv) Adequacy of requirements communicated to the external provider.

 

The organization needs to define – (i) Controls to be applied to external providers, and (ii) Controls to be applied to resulting output.

 

The organization needs to communicate to the external providers adequate requirements for the (i) Process / product / service, (ii) Product / service approval, (iii) Method / process /equipment approval, (iv) Release of products / services, (v) Required competence including qualification of persons, (vi) External providers’ interactions with the organization, (vii) Control and monitoring of the external providers’ performance to be applied, (viii) Verification and validation activities to be performed at the external providers’ premises by the organization or its customer.

 

The organization needs to apply – Determined controls, criteria and other activities.

 

The organization needs to retain documented information (records) – Evaluation, selection, monitoring of performance and re-evaluation of external providers and any action arising from these activities.

 

In short  

 

Clause 8.4 of ISO 9001:2015 QMS standard focuses on the control of externally provided processes, products and services. Here are a few examples of control that can be applied to meet the requirements of this clause:

 

1.     Supplier evaluation and selection – Implementing a well-defined process to assess and select suppliers based on their ability to meet the organization’s requirements. The process may include evaluating supplier’s quality management system or its certification, product / service quality, delivery performance, financial stability etc.

 

2.     Supplier performance monitoring – Regular monitoring and evaluating the performance of the supplier with reference to on-time delivery, product / service quality, compliance with requirements etc.

 

3.     Communication – Maintain effective communication with the supplier to facilitate a better and mutual understanding of requirements, changes, and any potential issues. Efforts can be made to conduct regular meetings and prompt communication with suppliers.

 

4.     Incoming inspection and verification – Establish procedure for inspecting and verifying externally provided process / product / service upon receipt.

 

Control on external providers’ property

 

Clause 8.5.3 of ISO 9001:2015 QMS standard stipulates requirements on property belonging to customers or external providers. Exercise following controls on the external provider’s property –

 

1.     Exercise with external provider’s property (such as material, components, tools, equipment, premises, intellectual property and personal data) while under the organization’s control or being used.

 

2.     Identify, verify, protect and safeguard the property provided for the use or incorporation into the product / service.

 

3.     Report to the external provider any property belonging to an external provider is lost, damaged or otherwise found to be unsuitable for use.

 

Think of the following Questions

 

(1)   What are externally provided processes, products and services?

 

(2)   Why an organization need to control externally provided processes, products and services?

 

(3)   What documented information you may need to retain for externally provided process / product / service?

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

Thanks.