How Is Your Workplace Related to QMS

How Is Your Workplace Related to QMS


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.



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.


How can QMS Software Improve Profitability 1

How can QMS Software Improve Profitability


How can QMS Software Improve Profitability

Adopting a QMS or Quality Management System unfolds myriad benefits to an organisation while rewarding it with an almost definite rise in its profitability. However, besides requiring an active change in the employee’s mindset, implementing a QMS in an organisation involves a wide array of new procedures and processes. Here is where a QMS software comes as an effective tool for accomplishing an easy and smooth execution of an otherwise daunting task.


Strikingly useful features of QMS software

While supporting ISO 9001 prescribed standards, a QMS software provides a structured format to fit in all quality-related business operations. Typically, with its given features, a software can help businesses in the following ways:

  • It schedules key business activities such as process checks, administration maintenance, and Quality Quality tasks.
  • It serves as a centralised register for keeping records and inputs, such as customer feedback, complaints, accidents, staff suggestions etc.
  • It tracks improvement while providing documented evidence of task completion.
  • As an audit manager, it adopts a systematic approach to ensure execution of documented policies, procedures and processes.


How QMS Software Increases Profitability


Provides Quantifiable Data on Quality

One of the chief advantages of working with a QMS software is that you get quantifiable data on various aspects of Quality, on a regular basis. The data generated by the digital machine can be utilised by managers to suggest and instruct the staff on changes, as when and where they are required. The reports generated by the QMS software also bring into focus the progress achieved in tasks enforcement and lacunae which need to be looked into. With time as organisations learn to base their work on reports from data analysis, a definite quality culture shapes up. The regular monitoring and feedback provided by the software while reducing defects contribute to quality based output, thus furthering the company’s profits.


Ensures Customer Satisfaction

ISO 9001 specifications demand organisations to conduct their business operations in a customer-centric manner. A QMS software is equipped to monitor different facets of business processes, tasks and operations to ensure quality output. It provides the staff with easy measurements, analyses performances and keeps a safe account of all documents. In this all-encompassing way, the software ensures the user company to offer quality services and products to customers, which in turn furthers its profitability.


Promotes Organic Business Growth

By delivering satisfactory products and services, a company retains its existing customer base and also, in course of time, expands it. The older customers give referrals and create new ones for a company. Without a quality consciousness in its work, no organisation can attain business growth. The QMS software through its regular metrics and updates ensures a continual improvement in QMS. Maintenance of quality culture is imperative for higher profits


Helps Curtail Wastage

A QMS software helps an organisation maintain a documented with error log so that the managers can keep an eye on staff performance and also on the efficiency of the processes. The software gives out prompt notifications to indicate product defects and inefficiency in processes. This data should promptly look into check loopholes in services and production. Timely and routine checks can contribute to curtailing wastage in an organisation in a big way. Cutting down on costs is never a bad business idea!


Helps Improve the Tender Process

Since QMS software support ISO standards, they can be extremely useful for organisations aspiring for ISO certification. The certification is declarative of the compliance of its holder to international quality standards. ISO 9001 is recognised in more than 88 countries, while many business houses and suppliers across the world prefer to work with ISO certified companies alone. Bearing certification awards respect and a greater reputation to companies and helps them in passing their business tenders with relative ease. The business of an organisation, in the process, expands, leading to a wider profit base.



A QMS software is a valuable asset for an organisation. Its multifarious operations provide quantifiable data to measure performances, thereby keeping the management and workers on alert for delivering quality output. In, this way a QMS becomes an indispensable tool for furthering business and profits.

Capturing your problem is the most important step in QMS


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.


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.

Which Production Metrics Must You Track To improve QMS 1

Which Production Metrics Must You Track To improve QMS


QMS or Quality Management System, with its array of metrics, is a valuable tool for organisations to determine and continually improve the quality of its goods and services. The ISO requires all organisations in all types of industries to comply with certain standards primarily with a view to catering adequately to customer’s satisfaction and adhering to environmental and safety standards. To check if your organisation is on the right side of QMS you need to check certain Production metrics.

Production Metrics you need to track

QMS calls for a continual improvement of the production processes, requiring organisations to keep a constant eye on visible production metrics. For the best quality improvements in your organisation, you could consider the following Production metrics which provide quantifiable data.

Metrics to Improve Quality

  • Yield: This metric calculates the percentage of correctly manufactured products in accordance with the standard specifications without any rework.
  • Customer Rejects/Return Material Authorizations/Returns: This is a measurement of the number of times customers rejected products and requested replacement owing to their low quality.
  • Supplier’s Quality Incoming: This refers to the percentage of satisfactory material for manufacture sourced from the supplier.

Metrics for Improving Efficiency

  • Throughput : This is the measure of the product being produced on the factory floor or on a machine or a line in a given period of time.
  • Capacity Utilization: is the measurement of the total manufacturing output capacity is utilized at a given point in time.
  • Overall Equipment Effectiveness (OEE) : Provides various metrics on machine or an entire production line. It is the product of Availability x Performance x Quality.
  • Schedule or Production Attainment: the metric pertains to measuring the percentage of time consumed in production within a specified schedule.

Metrics for Reducing Inventory

  • WIP Inventory/Turns: this is a radio calculation for measuring the efficient use of inventory materials derived from the cost of sold goods by the average cost of inventory utilised for their production.

Compliance Metrics

The compliance metrics drive the firm towards better adherence to the mandatory rules and regulations of different authorities. These include the measurement or an account of :

  • Reportable Health and Safety Incidents : A measure which accounts the number of health and safety related incidents in the factory or plant in a given period of time.
  • Reportable Environmental Incidents : A measure of the number of adverse environment- related incidents that were recorded as occurring over a period of time.
  • Number of Non-Compliance Events / Year : this metric entails measuring and documentation of events during production that violated the existing regulatory compliance within a period of a year. The details of the reason. Time and their resolutions need to be mentioned also.

Reducing Maintenance Metrics

This includes :

  • Percentage Planned vs. Emergency Maintenance Work Orders
  • Downtime in Proportion to Operating Time

Increasing Flexibility & Innovation

The New Products Introduction (NPI ) metric reflects how well a company is at striking and exploiting markets with its new products. The automation and electronics sector is especially known for utilising this metric to gauge their standing in the competitive market environment. This can be assessed with the help of –

  • Rate of New Product Introduction
  • Engineering Change Order Cycle Time

Reducing Costs & Increasing Profitability

This metric includes the following:

  • This can be calculated with a host of metric that include
  • Total Manufacturing Cost per Unit Excluding Materials
  • Manufacturing Cost as a Percentage of Revenue
  • Net Operating Profit
  • Productivity in Revenue per Employee
  • Average Unit Contribution Margin.
  • Return on Assets/Return on Net Assets
  • Energy Cost per Unit
  • Cash-to-Cash Cycle Time
  • Customer Fill Rate/On-Time delivery/Perfect Order Percentage


QMS is a valuable tool in organisations for observing and furthering the culture of quality. It is imperative, then, that management tracks the right Production metrics for attaining quality that comply with safety standards and customer satisfaction.

Setting up a Pharma Unit What latest Quality Management systems should I follow 1

Setting up a Pharma Unit? What latest Quality Management systems should I follow?


If you are embarking on a venture of setting up a pharma unit, it is imperative that you beforehand understand the vital needs and functions of a pharmaceutical quality system. Today, quality consciousness for all products is rife among customers. When it comes to the pharmaceutical industry, expectedly the need to deliver quality assumes paramount importance.

Pharma products directly affect people’s body and health. Hence, in a bid to ensure quality and safety standards, regulatory bodies like the FDA exercise rigorous and continual surveillance over their manufacturing. Additionally, the International Conference on Harmonization provides internationally harmonized guidance to pharmaceutical companies. ICH Q10 demands a quality management system ( QMS) for the Registration of Pharmaceuticals for Human Use and USFDA. If you seek to establish a pharmaceutical manufacturing unit and achieve success, remember you cannot do it without a robust QMS.

Latest QMS you should follow

Your QMS should be based on the guidelines of the latest pharmaceutical quality system which is internationally recognised and accepted. The International Conference on Harmonization (ICH), a joint initiative of Regulators and Research-based bodies spanning Europe, Japan and the US has devised standards and procedures for the pharmaceutical industry for attaining quality excellence in their products and services. Its chief aim is to ensure production based on – Safety, Quality and Efficacy. ICH 10 expounds a QMS model guided by the International Organization for Standardization (ISO) standards. The model encompasses and addresses critical quality concerns like good manufacturing practice (GMP), and complements regulation while emphasising on innovation and continual improvement during the entire length of the production cycle.

At the basic level, your pharma unit’s QMS should accomplish:

a) A proper system of infrastructure outlining the organizational structure, procedures, processes and resources

b) A set of systematic actions for contributing to the eventual delivery of quality based, customer-satisfactory products and services. This system will aid your QMS staff in performing Quality Assurance functions smoothly and efficiently.

Key Functions of a Pharmaceutical QMS

A pharmaceutical company is engaged in the manufacturing and sale of biotechnology and biological products. Your manufacturing processes would require constant and several layered quality checks at each stage and at all levels of the product lifecycle.


a) APIs development and manufacture

b) For investigations manufacturing of medical kits and devices

c) An efficient medical delivery systems

d) Pilot plant activities

f) Development of the essential medical devices for measuring accurate dosing

Analytical – manufacturing-related

a) An effective system of checks for acquisition and control of materials

b) Adequate provision of facilities and equipment

c) Production-related to including packaging and labelling

d) Storage at the stage of product technology transfer

e) Testing and quality assurance mechanism

System for product discontinuation

a) Sample retention and maintenance of documents

b) Continual assessment of products and reporting

Quality Management System in Testing Laboratories

While abiding by the ISO mandates on risk and safety, your laboratory staff would need to align its testing activities in line with them. Keeping the end-user in mind the pharmaceutical companies should possess a well-equipped laboratory manned by qualified, trained and skilled medical professionals. The staff is obliged to offer rigorous testing for all the company products and services before they are packaged for market.


Given the nature of their needs, the products and services of the pharmaceutical sector need to manufactured and provided under stringent regulations. Commonly, legal actions are taken against non-compliant firms. Hence, if you are to set up a pharma unit, keep quality production as your top-most priority. And, it goes without saying the purpose cannot be achieved without the presence of an active, alert and robust quality management system.


What’s most difficult while implementing a QMS system

What’s most difficult while implementing a QMS system


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.


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.

Whats new with IAFT 16949

What’s new with IAFT 16949



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.


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.

Review your QMS systems regularly

Review your QMS systems regularly

Review your QMS systems regularly

Review your QMS systems regularly


The success of a QMS or Quality management system adopted by your company largely hinges on the critical concept of continual improvement, enabled through regular reviews. A QMS review offers you the opportunity to modify, change and improve upon your quality program. Maintenance of continual improvement directly helps you with delivering quality products and services to customers and winning over their prized satisfaction. Regular QMS reviews are also mandatory if you desire your company to be awarded the esteemed ISO 9001 certification. Your organisation’s overall success is in a significant part dependent on the efficient running of your QMS; hence review it vigorously, and timely.


QMS Review Frequency

The frequency of QMS reviews is determined chiefly by the maturity level of your system. Depending upon your system’s review requirements, you could hold adopt one of the following review-schedules :

  • Annual Schedule Meeting
  • Bi-Annual Meetings
  • Weekly Meetings

In the initial or rawer stages of its implementation, the QMS requires reviews spaced over shorter periods, which enables you to closely watch over its output and performance. However, if your QMS has matured to a significant stage, it would suffice to review it annually.


Establish a review procedure

Before you set on to conducting reviews, make sure to develop a documented procedure which can be followed throughout the year. The document should outline the frequency, the required team and, the aims and objectives of the review. The inputs and outputs expected from the exercise also need to be woven into it.

The inputs is the set of information drawn from actual quality records which have been documented and contain information garnered in the previous review meetings. The list should include data on – quality metrics, performance, conformance etc along with improvement plans and recommendations.

At the end of a review, based on its findings and results you should prepare an output plan enlisting – items for the future actions on a programme like Gantt chart. The list should specify the action item or task, staff responsible for execution, the due date along with the mention of corrective or preventive plans if any. The final report must bear the signatures of all the participants.


Select the right team for reviews

Your QMS review team should be eclectic. To gain the best review results opt for a cross-functional team approach. The team should ideally comprise representatives from the top 2 or 3 management levels of the organisations engaged in quality activities, headed by the senior management. Your review team could include personnel like President or Operations Manager, Quality Assurance Manager, Facilities Manager, Production Manager, Engineer Manager, Purchasing Manager and Sales Manager.


Document the reviews

Documentation is one of the most important aspects of the QMS. After every review have your documentation department document all the details of the reviews, the documents should be all comprehensive and drawn out in a methodical manner. A proper document will be useful to your staff for future reference for their quality improvement tasks and processes.

If you are aspiring for ISO certification, it is necessary to follow its recommendations for documentation. Well-designed documents will be of exceptional help at the audition stage.ISO auditors seek several documents which feature details related to quality tasks such as – performance, management’s involvement, compliance etc. An impressive set of documents with details of all reviews will instil confidence in the auditors your organisations endeavour towards quality goals.


QMS is a dynamic and an elaborate system to help your organisation observe and maintain quality practices. However, like any other system in your organisation, its success depends much on its periodic reviews. Since you have invested your time, efforts and resources for it, and much of your business success is at stake it would be worth assessing it at regular intervals.

Also read on

What Is Lean Manufacturing And How it is Related To QMS

What Is Lean Manufacturing And How it is Related To QMS


Across the world, in the realm of manufacturing industries, Lean Manufacturing is gaining a growing acceptance. As a sociotechnical production methodology Lean believes in banishing all waste while maximizing productivity. Today, several big manufactures like Nike and Caterpillar Inc. as well as those in non-manufacturing sectors are successfully implementing its principles which find their echo in the QMS (Quality Management System)

5 Core Principles & Working of Lean Manufacturing

Lean Manufacturing works on the basis of 5 core principles which include – value, the value stream, flow, pull and perfection. When an organisation works out of this value system, emphasises value while adhering to customer’s expectations, detects  processes entailing waste, Value stream-lines processes harmoniously into an uninterrupted flow, and when unnecessary exercises production restrain.

Lean principles


How Values of Lean Manufacturing and QMS Overlap


Value, for both QMS and Lean manufacturing entails valuing customers satisfaction. QMS also believes in following safety and environmental standards set by authorities. Firms following Lean Manufacturing and QMS draw out the objectives on the basis of ‘value’ and ‘standards’. The subsequent blueprint for achieving is also based on the same value system.

A QMS system takes into account customer’s needs and encourages firms to haul their activities in accordance with them. An order from customer is met only when after formally establishing that the company is fully capable of meeting it. Targets setting, KPI or key process indicators are set at this stage on values similar to ‘value’ principle of QMS.

Value Stream

The Value stream of Lean Manufacturing seeks to line processes harmoniously into an uninterrupted flow in the manufacturing operations. Lean follows this principle for the execution of its blueprint. Though, initially, this is done only on a trial basis. The idea behind this is to check whether the process generates maximum output while engaging into minimum waste.

Under the column of Product Realization, QMS states that – “The organization shall plan and develop the processes needed for product realization (production).” Thus, it also calls for processes to be streamlined for harmonious activity of production.


Firms need to concentrate on a process that ensures smoothness in the flow of the remaining steps. Lean Manufacturing experts have devised some useful strategies to ensure the principle of ‘flow’ be followed, these include: breaking down of processes into steps, reconfiguring the range of production steps, evening out the workload, creating cross-functional departments etc.

QMS, too, believes in a thorough checking of quality of the processes and activities involved in production before executing them. Section 8 comprises subsections of Continual Improvement, Corrective Action and Preventive Action which at places overlap with the Flow principle of Lean.


A pull-based system believes in limiting inventory and it sees to it that the requisite material and information are available for work in process (WIP). Hence, a pull-based system can fulfill a Just-in-time delivery and a manufacturing system wherein products are created as per the end customers’ requirement. Working backwards in the production stream ensures better quality of output, something that QMS too, aspires for.


The fifth and step of perfection is the most important principle of all. It casts the organisation into a culture of lean thinking and continuous process improvement as demanded from QMS. Employees are trained to strive towards imbibing the principle of quality in all their workplace tasks.


Both, Lean Manufacturing and QMS find a common ground in enunciating their core belief in quality standard for customer satisfaction. A synergy of the two would be phenomenally beneficial to all organisations.

Pharma Manufacturing

How to tackle warning letters in Pharma Manufacturing?

Pharma Manufacturing Warning letters are issued by the FDA to people or associations for infringement of regulatory importance. While they are naturally casual and warning, their definitive point is to set up intentional compliance with the law. This blog will display the best practices and proposals that can be utilized to enhance a Pharma covigilance association’s structure, create proper SOPs and procedures, measure the performance of critical PV works, and guarantee examination status.

Warning letters come with the variety of reason to blame or claim one pharmaceutical manufacturing company with valid forms from the FDA association. There are plenty of procedures involved in this manufacturing system, so there are chances of failure in any one or many of them. So it is truly hard to explain how to handle each one of the failures or the blames.

But now we will share with you how to tackle any Warning Letter from the FDA for the Pharma Manufacturing companies.


Pharma Manufacturing


Proper and finish response to form 483 is significant. Following a review, the FDA will issue a form 483 posting its discoveries. The organization normally has 15 days to react. It’s fitting to utilize the accompanying accepted procedures while reacting to form 483. The following:-

  1. Address every perception independently
  2. Recognize the issue
  3. Show a comprehension of the issue
  4. Assess the effect and decide the reason
  5. Depict rectification and precaution activities obviously and in a way that passes on comprehension of the issue and an exhaustive underlying driver investigation
  6. If possible, amend infringement promptly and tell in 483 response
  7. In the event that conceivable, give confirmation of these activities
  8. It is critical that every response address the focal issue(s) recognized in the perceptions made by the FDA. It ought to likewise give real and target prove that can be assessed and help in understanding the response.

But, if reasons mentioned in the warning letter seems wrong to the manufacturing company, you can’t help contradicting the 483 perceptions, you have to help this with clear confirmation, actualities and information, and clarify why the perception is mistaken as opposed to just overrule the cases of the FDA.

Frequently when the FDA composes a warning letter, they need to report an organization’s absence of compliance against a specific control that has been damaged. It’s uncommon to see a general remark embroiling an extensive variety of things. They will dependably recognize the direction that has been disregarded. Subsequently, the most widely recognized discoveries from warning letters, for the most part, identified with Pharmacovigilance essentials, for example, multi-day reports, PADER issues and SOPs.

Rehash discoveries and poor responses to the form 483 increment the danger of a warning letter definitely and there are not kidding results for inability to amend the issues distinguished in the warning letter. An association must be proactive and set up procedures and techniques that keep these issues from emerging and in this manner dodge an FDA warning letter.