ISO 9001:2015 QMS Awareness – Performance evaluation – Management review

ISO 9001:2015 QMS Awareness – Performance evaluation – Management review

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Management review = Management + Review = Review carried out by the top management of the organization

 

Management = People with authority and responsibility for conduct and control of the organization

 

Review = Determination of the suitability, adequacy and effectiveness of the quality management system of the organization

 

Purpose of the management review – (1) To ensure continuing suitability, adequacy and effectiveness of the quality management system (being implemented in the organization), and (ii) To ensure the alignment of the quality management system (being implemented in the organization) with the strategic direction of the organization.

 

Responsibility – Top management of the organization

 

Top management of the organization needs to plan and define – Intervals to conduct management reviews.

 

ISO 9001:2015 QMS standard does not provide specific intervals for conducting management reviews. It is for the organization to determine suitable intervals for conducting management reviews based on the organization’s needs, context, size, complexity, industry requirements, risks considerations and effectiveness of the quality management system (QMS). Typically, management reviews are conducted at regular intervals. Some organizations choose to conduct management reviews annually. Some other organizations may choose for more frequent reviews, such as quarterly or half-yearly.

 

Top management of the organization needs to plan management review by considering inputs. Management review inputs are – (i) Status of actions from previous management reviews, (ii) Changes in external and internal issues relevant to the quality management system of the organization, (iii) Information on performance and effectiveness of the quality management system of the organization, including information on trends in customer satisfaction, information on feedback from relevant interested parties meeting quality objectives, process performance, product / service conformity, nonconformities, corrective actions, monitoring and measurement results, external providers’ performance, (iv) Adequacy of resources, (v) Effectiveness of actions taken to address risks / opportunities, and (vi) Opportunities for improvement.

 

Top management of the organization needs to conduct management review at defined (planned) intervals by considering inputs and by taking decision and action on – (i) Opportunities for improvement, (ii) Any need for changes to the quality management system of the organization, (iii) Resource needs.  

 

The organization needs to retain documented information (records) of the results of the management review.

 

There may be some questions, such as (i) What may be the opportunities for improvement? (ii) What may be any need for changes to the quality management system of the organization? (iii) What may be resource needs? Let us understand.

 

Opportunities for Improvement – Opportunities for improvement refer to areas within the organization’s quality management system where change, enhancement or refinement is made to have a better process, product or service. Opportunities for improvement can arise from various sources, such as: Feedback from relevant interested parties including customer feedback, internal audit, monitoring key performance indicators (KPIs), suggestions from employees working for the quality management system of the organization.

 

Any need for changes – Any need for changes to the quality management system of the organization refers to find out (identify) changes to the organization’s quality management system that can be prompted by various factors, such as: (i) Revision in legal (statutory and regulatory) requirements, (ii) Technological advancement, (iii) Changes in organization’s structure, process, product or service, and (iv) Lessons learned and experience gained from nonconforming outputs, incidents, corrective actions that can reveal weakness in the quality management system of the organization.

 

Resource needs – Resource needs refer to the allocating and providing necessary resources to address improvement in the quality management system of the organization that can include human resource, infrastructure including upgrading / acquiring new equipment / technology / facility, improvement in the skill and knowledge of employees by providing relevant training.

 

Think of the following Questions

 

(1)   Why is management review important?

 

(2)   Who to conduct management review?

 

(3)   What are the management review inputs?

 

(4)   What are the management review outputs?

 

 

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/

 

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ISO 9001:2015 QMS Awareness – Performance evaluation: Internal audit

ISO 9001:2015 QMS Awareness – Performance evaluation: Internal audit

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Audit = A process for obtaining objective evidence

 

Audit = A process that is systematic, independent and documented

 

Audit = A process for evaluating the objective evidence objectively to determine the extent to which the audit criteria (set of policies, procedures, requirements) are fulfilled

 

Purpose of internal audit – To conform (i) Whether the quality management system of the organization conforms to the requirements of ISO 9001:2015 QMS standard and requirements determined by the organization, and (ii) Whether the quality management system of the organization is effectively implemented and maintained.

 

The organization needs to consider – (i) Importance of processes concerned, (ii) Changes affecting the organization, and (iii) Results of previous audit(s).

 

The organization needs to plan and establish – Audit programme (that also include the frequency, methods, responsibilities, planning requirements and reporting). 

It should be noted that specific frequency for conducting internal audit is not mentioned in the ISO 9001:2015 QMS standard. The organization should determine the frequency of internal audit based on the organization’s needs, importance of the processes being audited, and the results of previous audits. 

 

The organization needs to define – Audit criteria and scope (for each audit).

 

The organization needs to select auditors to carry out internal audit (Ensure objectivity and impartiality).

 

The organization needs to implement and maintain – Planned and established audit programme.

 

The organization needs to conduct – Internal audit at planned intervals (ensure objectivity and impartiality).

 

The organization needs to report – Results of the audit to the relevant management of the organization.

 

The organization needs to take – Appropriate correction and corrective actions at an early date (without undue delay).

 

Here it is important to understand the terms ‘correction’ and ‘corrective action’.

 

Correction = An action to eliminate a detected nonconformity

 

Corrective action = An action to eliminate the cause of a nonconformity

 

Corrective action = An action to prevent recurrence of the nonconformity

 

Correction focuses on rectifying the immediate nonconformity, while corrective action aims to eliminate the root cause of the nonconformity and prevent its recurrence.

 

The organization needs to retain documented information (records) of – (i) Implementing audit programme, and (ii) Audit results.

 

For more guidance on auditing management systems, it is suggested to please refer to ISO 19011:2018 standard, Guidelines for auditing management systems.

 

Think of the following Questions

 

(1)   Why is internal audit important?

 

(2)   Can an internal auditor audit his own work?

 

(3)   What are the requirements for internal audit?

 

(4)   What is the difference between the term ‘correction’ and the term ‘corrective action’?

 

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 – 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.