How Is Your Workplace Related to QMS

How Is Your Workplace Related to QMS

Introduction

How Is Your Workplace Related to QMS or Quality Management System serves as a framework to lead and guide an organisation towards improved quality practices at all levels of its internal processes, including manufacturing operations. It derives its principles from ISO 9001 which mandates companies to comply with certain standards to ensure the provision of satisfactory services and products to customers. While implementing the QMS principles your workplace engages itself with continual improvement towards shaping, promoting and maintaining quality culture. A sincere and consistent adherence to quality practice rewards you with ISO certification, spurring an impressive rise of profit lines.

 

Workplace Practices To Promote QMS

The successful implementation of QMS requires that your business activities be based on quality principles and standard as specified by the ISO 9000 series. The following discussion throws light on how to orient your workplace in a bid to promote and maintain a continuous quality culture within it.

 

Maintaining customer focus

The ISO principles require that your organisation, at each level of operations, keeps customer satisfaction in mind. To ring in customer satisfaction your company should focus upon:

  • Conducting regular research to understand customer needs and expectations, along with a parallel management of customer relationship.
  • The vision and objectives of the company should be aligned with the needs of the customer.
  • An active communication system to translate quality principles into action at all levels of the organisation.
  • Decision-making and planning on the basis of quantifiable results derived from quality metrics.
  • Implementation of quality operations through a balanced approach to maintaining the interests of all the stakeholders- customers, higher management, employees, suppliers, financiers, environment and local communities.

Committed Leadership

The ISO standards for the fulfilment of quality goals require complete commitment from the top management. In your role as the company’s leader, your responsibility entails:

  • Chalking out realistic and achievable goals and targets, along with a fair allocation of resources to all the departments.
  • Implementing QMS through a unified and centralised structure.
  • Creating, promoting and sustaining shared values of fairness and ethical conduct across the organization
  • To impart training to the staff on issues related to QMS
  • Having an active system of reviews and feedback on employee output, while motivating them for continual improvement.

Adopting a Process approach

A process-based approach for quality tasks execution is widely prevalent in organizations. Under the Process-based approach, your workplace management and employees should perform the following tasks:

  • Clearly defining the set of business plans, mapping processes and activities necessary to obtain the desired result
  • Establishing a team for handling duties and responsibilities related to QMS
  • Devising or installing a QMS software to measure and analyze the capability of key quality functions.
  • With the help of quality metrics conducting reviews and audits to evaluate the impact of plans for customer satisfaction and on other stakeholders.
  • Continually improving the system through measurement and evaluation.

 

Continual improvement

The ISO 9001 stresses upon continual improvement in the organization’s overall performance so that it can deliver quality goods and services to the customers. To this end, you need to ensure:

  • Implementation of a centralised system across the organisation to monitor employee performance through quantifiable data.
  • Providing knowledge and training to staff to follow methods and tools of continual improvement
  • Drawing out specifications and guidelines for process execution and product designing, while keeping customer satisfaction as your predominant goal.
  • Establishing a system of metrics to track continual improvement, while maintaining a system of feedback to the employees.

Factual approach to decision making

The most effective decisions are those based on the analysis of quantifiable data and information. For making decisions based on data, the management should install a comprehensive QMS software which performs the following tasks:

  • Availability of data and information which are sufficiently accurate and reliable
  • Disseminating the data in the pertinent departments.
  • Rigorous and regular analysis of data and acting upon the loopholes or lacunae as reflected by the system.

 

Conclusion

In a bid to outshine your competitors and staying ahead your organisation should adopt and implement the principles of Quality Management as mentioned in the various standards of the ISO 9000 series. The active implementation of QMS would change the very face of your business operations, helping your company in attaining soaring profits.

 

Capturing your problem is the most important step in QMS

Introduction

Capturing your problem is the most important step in QMS A new QMS or Quality management system in an organization overhauls to enhance its whole array of business activities. Its implementation, undoubtedly, is immensely challenging, while involving a radical shift in employees’ mindset and sprawling new investments. Every company possesses a unique set of quality-related problems which it seeks to address through QMS.  Therefore, it imperative that before implementing the new Quality solution, the top management captures its problems which require redressal. This act is advised to prevent a host of wastages over business time, efforts and resources.

Reasons why problem-capturing is essential

The discussion below attempts to make sense as to why the capturing problem is critical to QMS.

Helps set priorities, plans & goals

A QMS needs a well-defined structure, based on specific objectives, plans, and goals. The problem areas related to quality need to be highlighted so that QMS plans can integrate solutions for solving them. The overarching QMS then assumes a realistic base, while doing away things that are unnecessary. The employees can work with the QMS with more clarity and design result oriented action-plans, entailing processes and physical operations. When the entire workforce reckons the reasons for implementing QMS, their work gains more traction, ensuring quality output from its tasks.

Clarifies QMS operations

Once quality problems are defined, elaborate and effective quality plans and sub-plans can be mapped for a productive implementation of QMS. The vision for workers is thus clarified helping them produce better qualitative and quantitative results. A QMS plan offers solutions to problems by suggesting standard processes and practices. It also helps define processes, process owners, and the necessary tasks to capture data for quality metrics such as – Quality, Efficiency, Compliance, Maintenance, Reducing Production Costs etc.

Helps in continual improvement

When a QMS in part works specifically towards improving the lacking areas, it needs to look out for metrics and reports based on quantifiable data. A QMS software could be of immense help to an organisation to track its progress on various processes at different levels of operations and manufacturing. This, in turn help the management to scale the levels to which their existing problems are being solved, based on which future plans for improvement can be devised. Periodic reviews become an inherent part of QMS contributing to the cause of continual improvement.

Reviews and audits become more focused

An audit is an essential QMS tool to take stock of a company’s progress of its quality related activities. The awareness of the problem, sensitisation of staff over it and solutions-oriented tasks streamline QMS functioning. Hence, audits can be conducted with more clarity, with a special focus on assessing the progress of an organisation in areas where it’s weak – the problem areas. Their analysis helps the staff to see deficiencies in performance, and thereupon take corrective measures.

Gears up QMS towards better customer satisfaction

Any organisation that serves customers quality products and services ought to rise. On the other hand, if it ignores or fails to work upon the problematic quality areas would be unable to win customer trust. Hence, it is essential for a workplace to understand its specific quality weaknesses before the adoption and implementation of QMS. A system streamlined to work towards eradicating inefficient quality-related processes would eventually deliver output for better customer satisfaction.

Conclusion

Ignoring quality related problems or their inefficient handling by the QMS would only result in an inferior-quality yield, thus leaving customers wanting. In contrast, their effective dealing through a QMS would ensure customer satisfaction.  Hence, capturing problems is the most critical step before QMS implementation.

What’s most difficult while implementing a QMS system

What’s most difficult while implementing a QMS system

Introduction 

QMS or Quality Management System entails and demands from organisations systematic and continual processes of improvement on the quality front. Keeping customers requirements in mind, it encourages organisations to prevent avoidable errors, adverse outcomes and reduction of waste during production.

Auditing – Most Difficult While Imposing QMS

QMS draws it guidelines on ‘quality’ from the standards entailed in ISO 9000: 2000, the latest ISO QMS version. This version is both expansive and exhaustive, thus, posing tenuous challenges to the companies for its fulfilment. The principles and standards of the version are adapted to the new and ever-changing international markets, businesses, and socio-cultural and political conditions of the day. Implementation of ISO in the newer context demands arduous efforts. Most organisations face maximum difficulties in the auditing process. Auditors need to evolve their own unique techniques since no definite method serves as the necessary recipe for their successful implementation of QMS.

What makes Auditing Daunting?

Auditors are placed in sensitive positions charged with maintaining or changing perceptions about their company. Their job while drawing up QMS audits need to be based on the following standards.

Auditing requires new mindset

The expansive scope of standards ISO 9000: 2000 demands newer approaches and style of work from the auditors, stemming from the rather drastically different mindset. In adherence to IAF (International Accreditation Forum) auditors need to constantly work in tandem with numerous certification bodies and registrars, which make new laws and regulations on safety, environment etc from time to time. Companies need to abide by them and provide evidence-based audits the the concerned authorities.

Requires regular and rigorous communication

Auditors need to work with a range of sections in the organisation, which also includes the two extreme ends of the spectrum – the top management and board of directors, and, the shop-floor workers. They have to undergo appropriate training to imbibe intellectual potential and socio-cultural sensitivity to accomplish successful communication. Collection of relevant data and feedback for audits entail vibrant interactions with the relevant departments.

Audits needs are expansive and complex

  • On Governance and Corporate Responsibility

Conformity assessment has significantly broadened for all organisations calling upon compliance with the latest ISO Quality standards. Auditors need to document with evidence the performance of the organisation on governance and corporate responsibility. Auditing principles mentioned in ISO 19011:2000 demand ethical conduct, independence, fair presentations and evidence-based approaches. Continual review of these principles assures quality and to attain it auditors have to have their toes on the track relentlessly.

  • On Practice of Environmental Standards

Environmental laws and regulations have become stringent for manufacturers worldwide, which find their expression in the latest quality management principles of the ISO version. Auditors through their reports establish how the overall results of the output align with the environmental friendly practices in the factories and plants. A positive report is critical for gaining conformities.

Conclusion

The socio-cultural, political and business context of commerce is always in a state of flux. However, in the flux what remains fixed in the heart of all the practices is Quality. ISO 90001 (quality) and ISO 14001 (environment) have brought forth new challenges to enterprises, especially to their auditing teams.

An active and dedicated auditing staff is required to implement the QMS principles so that their organisations attain the desired standards as spelt out by the ISO. Amongst other factors, organisations require impressive audits for their success.

Why is a quality management system is mandatory in the Pharma Industry

Why is a quality management system is mandatory in the Pharma Industry?

Introduction

The operations of the pharmaceutical industry are subject to strict regulations as it serves people directly for their health reasons. More than the products of any other sector, the pharma produce needs to be reliable on various parameters. Quality experts emphasise on the adoption of the quality management system (QMS) by the pharma firms in compliance with the ISO 17025  to deliver standard medical products to customers. Implementation of a robust QMS is mandatory for a pharmaceutical company. The QMS must factor in all conformity standards set up by regulatory bodies like the FDA, ensuring the delivery of safe and healthy products to customers.

Essential features of QMS in the pharma sector

In order to be effective, the QMS of a pharmaceutical company should incorporte the following features:

Organizational structures

Before implementing a QMS, a pharma company should work towards getting legally recognized. To make the QMS effective, the organization should have a structure congenial and supportive of its implementation. For standard compliance, the laboratory needs to well-equipped and staffed with skilled technicians. For monitoring the lab’s activities, the company must appoint a Technical manager with a well-defined role and set of responsibilities. The executive should have direct access to the management to keep it informed about the critical activities.

Technical staffing

It is of critical importance for organisations to man their labs with well qualified and skilled technicians, whose activities are monitored by a medico-quality expert. The staff should be well-versed with the handling of different types of equipment, sample testing, issuing test reports based on rigorous analysis.

Effective system of Documentation

Documentation is critical for the successful functioning of a QMS. It is a mechanism to standardise procedures for the manufacturing and testing tasks. It also serves as a basis for monitoring the quality system in the company. Good documentation should comprise a hierarchy of essential quality-related documents, the most important of them being Quality manual, which details out the policy, structures of the laboratory, procedures, and the technical and administrative responsibilities of the staff for the execution of the QMS.

Document Control

It is essential for all pharma companies to exercise rigorous control over their documents, both internal and external. The set of measures encompasses tasks on documents creation, amendments, reviews, approvals, distribution and their archiving. For observing continual improvement latest versions of documents based on compliance standards should be furnished to the technicians and testers and hence, their data should be validated by electronic records and automated data-capture systems.

Regular Audits

An audit is a systematic, independent and documented process undertaken by an organisation to obtain evidence for performance evaluation. The main objective is to asses to what extent the staff has been successful in fulfilling its audit criteria. All companies conduct two types of audits, internal and external. For these audits the quality staff should make all its quality documents readily available.  The management should clearly define for its staff the criteria, scope and objectives of the audits.

Corrective and Preventive Action

The onus lies with the erring organisation to delve into an investigation to determine the root cause of non-compliance or failure. Once the reasons are unravelled, corrective action needs to be undertaken promptly. After the resolution of non-conformity issues, the staff needs to devise measures to ensure a similar problem doesn’t arise in the future.

Complaints and Feedback

Customer complaints and feedback help pharmaceuticals to assess their the laboratory performance and effectiveness of their products. Hence, the QMS should develop a system to document, evaluate and conduct prompt follow-up actions. The staff should follow the standardised procedures to resolve customer complaints promptly.

Conclusion

Pharmaceutical organisations can produce quality products if they are under the reign of an active and effective QMS. Organisations dealing in manufacturing, testing or storage of drugs and other health-related medicines need to keep a constant watch on the quality of their products. Conformity to regulations and standards of international authorities make it mandotory for pharma firms to invest in a good QMS.

Whats new with IAFT 16949

What’s new with IAFT 16949

 

Introduction

IATF 16949 entails a set of quality system standard for the automotive industry based on ISO 9001 with an emphatic focus on customer specific requirements. It demands from the automotive sector compliance with a process-oriented quality management system that provides for continual improvement and defect prevention. A  development and replacement over SO/TS 16949, IATF 16949 came into effect by the initiative by the Automotive Industry Action Group members. Seeking to be interdisciplinary in its approach, the new certification brings in fresh elements related to risk management, customer satisfaction, leadership, and process. The chief driving force behind IATF 16949’s development has been risk-control to imbue more confidence in manufacturers on products they work with.

What’s changed?

The discussion below discusses the significant changes brought about by IATF 16949 in quality system standard for the automotive industry.

Increased documentation

Documentation is an integral part of quality management systems for all organisations, irrespective to the industry they operate in. In the automotive industry, more so, the quality system holds a paramount importance as it entails standards on safety too. Rightly, then, under IAFT guidelines organisations, a larger emphasis is laid on documentation.

Companies are required to maintain documented evidence and documentation work on the following:

  • From the quality management systems of the suppliers, a conformance to statutory and regulatory requirements is demanded
  • A continuous review of engineering standards used and changes across product lines should be documented.
  • Documentation of the supplier selection process for the purpose of assessing risks and maintaining product quality conforming to customer specifications.
  • Standardization of work at all levels of operations. This would include -instructions on product verification, in-process checks and shutdown verification.
  • Risk assessments should be documented, along with the analysis and their mitigation. This assessment needs to be carried out at all levels of the organization and at all levels of production.

Introduction of customer-specific requirements

ISO/TS 16949 had as its focal point organization’s requirements. But with IATF 16949 things have changed with its standards being customer-centric. To determine how well organisations are meeting the standards, they are now required to conduct audits around customer specifications and requirements. Customer needs and satisfaction, thus, acquires a centre-stage in the quality related actives of an automotive company.

Emphasis on Accountability and Safety

IATF 16949 standards have widened the scope of QMS or Quality Management System of an organisation, weaving in standards dealing with accountability and safety in a wider and a more rigorous manner. It makes it mandatory for organisations to implement policies on Corporate Responsibility, encompassing anti-bribery rules, mandatory codes, and ethics escalation policies.

Risk awareness and analysis

IAFT standards expound stringent policies on safety. As per them the automotive manufacturers and suppliers are mandated to incorporate risk management at levels of their quality system, including CAPA and FMEA. All employees should be adequately sensitised and trained to adhere to these standards in their daily tasks and operations. Non-conformity could call for adverse action from authorities and bad publicity too.

Conclusion

IAFT 16949 is a step in the right direction. It has rightly determined customer specifications, safety and ethical conduct to be an integral part of business operations. Its certification, therefore, holds much credibility. Organisations aspiring for it should work towards imbibing its standards in a sincere and methodical way. Although IAFT 16949 emphasises on customer specifications, eventually, those organisations adhering to its standards would find their way to business prosperity.

Quality Management System

5 Effective Steps to Monitor Your Quality Management System

5 Effective Steps to Monitor Your Quality Management System Implementing a Quality Management System in an Organization is always a challenge. A well implemented QMS system needs several important measures to be captured and tracked. So which exact parameters must one track? In this blog I will try an highlight just a few high steps to monitor effectivity of you QMS system.


Quality Management System
With time, we have understood that there are a lot of metrics which can help us in the measurements. And when we are able to measure our quality of work, we can definitely improve them accordingly, if needed. Taking the example of Reliance can give us a better understanding:

In the beginning, Reliance network did not get nationwide acceptance even after proving the users with good connection. And then with the usage of right metrics, it has detected the issues they are coming across which led them in the betterment of their quality. They kept on providing free schemes, cost-effective recharges, and also became a quality internet provider. And now, you can see where Reliance stands – JioFi has spread everywhere around India and they have managed to save their position with a good Quality Management System.

But the question is how they did that? What are the metrics they used to detect the problems and bring out the best quality across the nation? This is the topic of our discussion today. So, let’s get into knowing those helpful measures that assisted Reliance as well as many other companies to manage their quality of work in the industry:

Notification of Documents

First of all, we need to understand that developing a good Quality Management System can work the best for any further improvement. So the first metric that needs to get discussed is the notification of all the documents of a company – starting from the collection, maintenance, identification, to the amendment of technical and quality recording holds core importance.

But to come up with the best result, we need to make sure that the employees are getting notified with this information because they are the ones who are working in departments for the manufacturing. Until and unless they are going aware about how the company is working, the chances to develop gets decreased. So, in first hand, Reliance had to make sure that their employees are all aware about the drawbacks answer well as the strengths to work upon accordingly.

Audits

Audit is a very common term used in every industry – starting from manufacturing to banking sectors. Without auditing one can never be able to take action. It is actually the analytics of the documents with which employees of the respective companies have already been notified. It is a great metric to sort out the problems, the actions taken for it, if the actions have been taken on time, the good work etc.

Reliance also made sure all of these facts with auditing because this is best way to analyze and improve.

Overdue Trainings

When we are recruiting employees in our company, even the smallest of the smallest ones needs them to get trained according to the requirement of the system. We have to make sure that all such training programs are up-to-date. If any kind of training is still remaining, we have to ensure to complete them as soon as possible. So we have to keep a track of this to check everything is done on time.

At times, these training programs also need to get improved and this can be best done with the feedback of the employees. They are the heart of any company; so we need to take care of them in any and every situation.

Risk Assessment

Taking risks in our lives is a dreadful thing to do. And with companies, it can at times become devastating. But risks have always been a core part of any industry. So, we need to assess them correct them and that too well before time to take preventive measures. We must hold a record of those detected risks and the steps taken to get out of them. This record will aid us in detecting whether there is something else remaining or not.

Reliance really took a big risk while launching JioFi in their business but they had to take it for the betterment. And they made it, the risk was truly worth. They took all the measures to market this new innovation and the result was fruitful, we all know that.

Overdue Issues

Companies are facing problems every now and then. And most of the product related issues are reported by the customers with their feedbacks. So, companies need to have a track of all these issues and take necessary actions. But we must remember that in this case, the proverb of “Better late than never” does not work because the more we will delay in coping up with the issues, we will keep on losing the trust of our customers as well the quality of our company.

Thus Reliance truly coped up with all the issues they were facing in no time which definitely resulted in elevating them to the position of one of the top network providers.

5 Effective Steps to Monitor Your Quality Management System These 5 key steps can help monitor the effectivity of Quality Management System of companies. We will be happy to hear from you because your feedback has always been valuable to us.

Cheers!!

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Is quality everybodys responsibility?

quality everybodys responsibility Is your Quality Engineer being used for other tasks in your Organization? People say that Quality is everybody’s responsibility but here our experience is slightly different and we beg to differ. Quality consciousness can be everybody’s task but ensuring Quality should always belong to somebody or some group. And this entity must be empowered enough to take decisions. Just like everybody’s work is nobody’s work.

Making everybody responsible for the overall Quality means nobody is responsible for it. Depending on what your organization can afford set up and build your quality team. Ensure that the Quality team is placed at important gateways to identify issues at the right place. Only this can get you through. Just making your production guy responsible for Quality is a strategy bound to be doomed in the long run whatever the size of your Organization.

Is quality everybodys responsibility

So to have an effective Quality Management System set up in your organization and ensure that compliance objectives are met. Set up a responsible Quality Team. Let this Quality team be responsible for setting up the Quality Management System in the company. The production, dispatch, maintenance personnel can be part of the team but never held accountable.

quality everybodys responsibility The Quality head should be accountable. Set up clear Quality goals, documentation for relevant certification can be one of them, Use latest tools including QMS softwares. Review the tasks and progress on those tasks regularly only this can ensure an effective Quality Management System being implemented in your organization any thing midway might not get the desired results.

Check quality management software for manufacturing, Check quality management software for pharmaceutical