Quality manual as per

These enablers will facilitate achievement of the objectives described in Section above by providing the means for science and risk based decisions related to product quality. Knowledge management Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation.

For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components.

Sources of knowledge include, but are not limited to prior knowledge public domain or internally documented ; pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities. Quality risk management Quality risk management is integral to an effective pharmaceutical quality system.

It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

To ensure that the products manufactured meet the quality requirements of customer fully, a systematic approach for inspection and testing at all stage viz. At each stage, the activity is performed according to documented procedures. The control plan for incoming shall use one of the following methods —. The incoming materials used in production shall not be used or processed without acceptance by Receipt inspection.

Store Personnel are responsible for receipt, identification, records and storage of all Incoming materials, the detailed procedure for incoming material inspection is described.

All in-process inspections carried out according to the applicable control plans by QA during in process based on sample inspection and as per the documented procedures for the required tests. Responsibility and authority are assigned for segregation, review and disposition of non-conforming product. Documented information of segregation, review and suitable disposition of non-conforming materials are maintained by QA Personnel.

Who is authorized to review the non-conforming product? Xxx is evaluating the performance and the effectiveness of the quality management system.

Xxx is retaining appropriate documented information as evidence of the results. Xxx is determined the methods for obtaining, monitoring, and reviewing this information. The MKT In Charge has primary responsibility for Customer Satisfaction as one of the measurements of the Quality Management System and as to whether the organization has met customer requirements.

Customer satisfaction shall include the collection of authentic data, frequency, and validity of the analysis. The trend and major elements affecting customer satisfaction and key indicators of customer dissatisfaction will be monitored supported by objective evidence. Xxx is analyzed and evaluates appropriate data and information arising from monitoring and measurement. The results of the analysis are used to evaluate. Procedures are established for a system of planned and documented internal quality audits to verify that the Quality Management System conforms to the planned arrangements as per ISO requirements and effectively implemented and maintained.

The Management Review will include all elements of the entire quality system as detailed in the procedure and schedule for the Management Review. The Director during review shall assess opportunities for improvement and the need for changes in the Quality Management System, including the Quality Policy and Quality Objectives.

The Xxx is retain documented information as evidence of the results of management reviews. Xxx determines and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. These include. Improvement is included correction, corrective action, continual improvement, breakthrough change, innovation, and re-organization.

The details are as described in the procedure. Corrective actions are taken on customer complaints; by analyzing the causes of the complaints and taking suitable action to prevent their reoccurrence. The effectiveness of the identified corrective action is monitored through customer feedback and also the customers are kept aware of the corrective actions initiated, with each identified corrective action. Xxx continually improved the suitability, adequacy, and effectiveness of the quality management system.

Xxx considers the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of the continual improvement.

End of Example ……………………. Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your system development, training or auditing needs. He has helped dozens of organizations in implementing effective management systems to a number of standards. He provide a unique blend of specialized knowledge, experience, tools and interactive skills to help you develop systems that not only get certified, but also contribute to the bottom line.

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This greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in recommending appropriate solutions.

Training: He has delivered public and on-site quality management training to over students. Other services: He has provided business planning, restructuring, asset management, systems and process streamlining services to a variety of manufacturing and service clients such as printing, plastics, automotive, transportation and custom brokerage, warehousing and distribution, electrical and electronics, trading, equipment leasing, etc.

Prior to becoming a business consultant 6 years ago, he has worked in several portfolios such as Marketing, operations, production, Quality and customer care. He is also certified in Six Sigma Black belt. View all posts by preteshbiswas. Like Like. Can I get the picture you have used on this page. The process approach model with clause numbers.

You are commenting using your WordPress. You are commenting using your Google account. You are commenting using your Twitter account. You are commenting using your Facebook account. Notify me of new comments via email. Notify me of new posts via email. Skip to content. Draft policies based on applicable ISO requirements.

List operating procedures or refer to them as appropriate. Determine the format and structure of the manual and make the first draft. Circulate the draft manual for input from all departments and address inadequacies identified. Attain a formal approval and release. Example of Quality Manual 1. Abbreviation Description Sr. Management has established the quality policy and quality objectives for the quality management system and is compatible with the context and strategic direction of the organization.

The established procedure for promoting the use of the process approach and risk-based thinking. Ensuring that the resources needed for the quality management system are available, this is being periodically reviewed through management review meeting.

Communicating the importance of effective quality management and of conforming to the quality management system requirements Ensuring that the quality management system achieves its intended results Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system by providing training, conducting awareness programs and Promoting improvement by introducing the suggestion scheme, Kaizens and conducting meetings.

Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed c The focus on enhancing customer satisfaction is maintained and procedure for customer satisfaction is addressed 5.

Provides a framework for setting quality objectives Includes a commitment to satisfy applicable requirements Includes a commitment to continual improvement of the quality management system 5. Available to relevant interested parties, as appropriate. While assigning roles, responsibility, and authority, top management has considered and ensured that The quality management system conforms to the requirements of this International Standard The processes are delivering their intended outputs Reporting on the performance of the quality management system and on opportunities for improvement, in particular, to top management The promotion of customer focus throughout the organization The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Formulation of Strategy for continuous up gradation of Business and Quality System. Ensure periodic assessment of the performance of Quality System. Approval of Quality System Manual. Budget Approval for the organization. Provision of resources as required. Strategic decisions on developments and technical setups. To provide the leadership for efficient implementations of the system. Authorities: Approval of customers orders, P. Sanctioning leaves of all Staff. Approval of funds for Training needs.

All the authorities of downline personnel. Chairing Management review meetings. Project Planning Responsibilities: Overall coordination between client, project managers and office department. Follow up for Schedules. The entire responsibility of Quality. Monitoring Client Satisfaction. Coordination with the consultants. Disciplinary actions against the staff. Prime responsibility for the safety at the site Provision of a suitable working environment Ensure the quality system is established, implemented and maintained.

Authorities: Appointment of the staff, engineers and tech staff. Sanctioning the Leaves to Staff. Project Managers Responsibilities: Responsibilities for the entire Project work, i.

Quality, Quantity and Time. Coordination with consultants and contractors. Coordination with Consultants for drawings. Coordination with the Site engineers. Coordination with the client for the ongoing changes in drawings and projects. Monitoring site engineers work on a daily basis. Reporting to the GM Projects on the above issues Responsibilities for safety at the site. Good working environment.

Authorities: Make or force a required decision at all levels to achieve project objectives. Initiate actions on the Contractors and consultants for Quality, Quantity and Timeframe issues related to project work. Site Supervisor Responsibilities: Coordinating with all staff for the Quality related issues of Construction.

Daily Labour Handling for Civil Work. Monitoring of Work progress and daily reporting. Coordination with the Site Contractor for the daily work requirements.

Coordination with external agencies for calibration of instruments and material testing. Authorities: Initiate actions on the staff for non-fulfillments of the documentation related quality To stop and initiate corrective actions on non—conforming products.

Site engineer Responsibilities: Monitoring of site and labour contractors. Monitoring of work progress and daily reporting Preparation of work progress report. Control of non — conformities on site. Ensuring instruments are properly used and are with the status of calibration. Coordinate with all labour contractors to achieve continuous progress at the site as per schedule.

Communicate management decisions and information to Site subordinate staff. Implementation and follow up and regular monitoring of implemented ISO system at the site. Coordination with the Quality Person for Quality related issues. Coordinating Material Accountability at site Authorities: Initiating the corrective and preventive actions as needed on contractors and consultants.

Decision making on during any emergencies at the site. Preparation of Sales plan. Annual sales forecast. Monthly sales forecast. Implementation of sales plan. Authorized to obtain concessional acceptance for non — conforming product from the customer. Customer order review. Handling and coordinating customers Identification of resources, as applicable.

Maintain all documents related to the quality system. Coordinator for Management reviews. A true digital signature, using a computer method called public-key encryption, is a code that becomes invisibly embedded in the document.

The signature can be verified by anyone who has the signer's public key. This serves two purposes. First, it authenticates the person who signed the document, since only that person has the private key. Second, it authenticates the document, since if any part of the document has been changed since it was signed, the verification will fail.

A digital signature, then, proves that neither the signature or the document is forged or altered. Typed names and graphic images cannot do either — and neither can ink on paper. The degree of control for copies of the QM, and other documents in the quality system, varies from one organization to another. If the documents are electronic, control can be greatly simplified provided everyone who needs it has access to the computer system where and when needed. As shown on this manual, any printed copy is uncontrolled, and any electronic copy that is not on the organization's main file server is uncontrolled.

On the main file server, of course, there only needs to be one copy of the current version. When your people have access to the QM and other documents on the computer system, the need for printed documents goes down. That simplifies document control and reduces the amount of paper consumed. With an electronic document, such as this one, there is no need for old-fashioned page-level revision control.

There is also no requirement for page-level control in the ISO system. In this example case, the entire QM is a single document. By the nature of electronic documents, if a single character anywhere in it is changed, then the entire document is changed. Everywhere else in the world it would normally be prepared for A4 paper x mm , which would change where page divisions occur.

If the document is saved as an HTML file for use on a web page , then it could potentially be one continuous scrolling screen with no page breaks. If the document is saved as a binary object in a database, random sections could be extracted and displayed in any format. It is strongly suggested, though, that the QM and other controlled documents be published as searchable, tamper-resistant documents. It is never good practice to make modifiable documents available to people who have no need to modify them.

Software tools for the PDF format are available for most computer operating systems, so users are not restricted to particular platforms. The PDF format also has other advantages, including security, tamper-resistance, searchability, indexing, and more. There is no requirement that the quality manual mirror the conformance standard.

If the QM is used to demonstrate conformance to a number of requirements, it is impossible to do in a single QM. The manual should be organized in a way that is suitable for your organization, because your people are the ones using it every day.

A simple matrix can be used to reference parts of the QM to requirements in the conformance standards. Any terms that are specific to your company or industry, and used in the QM, should always be defined in the QM. Sharp readers will discover at least one acronym in the example QM that is not defined: MRO, which in this case stands for maintenance, repair and overhaul.

If the entire organization operates under the defined quality management system QMS , then there is little need to specifically define the scope. If the QMS applies to only part of an organization, then the scope must be explicitly stated. In the example QM, only the metrology department of the organization is covered by the QMS; the assumption is that the rest of the organization does not have a system that conforms to ISO In the example QM, the scope is defined in section 2.

Ever since ISO was released, there has been much discussion on how big or small the QM should be. Do not try to force it into an arbitrary small number of pages, but do not be overly verbose, either. The QM should be a top-level overview of how the organization operates and does business.