Blog – Page 2 – Quality Management Systems

What’s most difficult while implementing a QMS system

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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?

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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.

What’s new with IAFT 16949

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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.

Review your QMS systems regularly

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Review your QMS systems regularly

Introduction

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.

Conclusion

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.

What are the stages of implementing a Quality System in Pharma Manufacturing ?

What Is Lean Manufacturing And How it is Related To QMS

IoT AND OEE

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Iot, an abbreviation for ‘Internet of Things’ and a fascinating ubiquitous digital phenomenon is rapidly affecting all things in the world of industries and businesses. The manufacturing sector assuredly has tremendous gains to garner if it welcomes IoT with open arms. Already, by bestowing rich, actionable data to sensor-fitted machines, IoT is unfurling remarkable progress on factory floors.

The Overall Equipment Effectiveness (OEE), a reliable metric used as a baseline and benchmark to measure equipment efficiency has reportedly made significant progress with of IoT application. As per ARC Advisory’s Industrial IoT / Industry 4.0 Viewpoints OEE has showed an improvement of 24 percent – pretty impressive results for initial trials.

IoT – THE HARBINGER OF NEW CAPABILITIES

IoT bestows multifarious benefits to OEE, thus impacting it positively and helping it grow on upward curves..

Enhanced machine understanding for a better OEE

Modern-day machinery when digitally adjusted with the IoT ecosystem acquires fruitful dimensions to perform better. IoT enhances our detailed understanding of equipment primarily by way instrumentation and analytics, in turn, increasing OEE scores.

You might also like note that when a firm combines IoT applications along with machine learning via Artificial Intelligence (AI), it opens doors to a much bigger array of possibilities. The chief service offered by IoT analytics (sensor analytics) on OEE is the

measurement of time taken by machinery in manufacturing products.

IoT Connecting with devices

Significant contributions for improved production line

Significant improvements via IoT data feed can also improve OEE by helping it focus on the production lines. Amid concerns over machines, issues related to shifts and change-overs during production run tend to get neglected. A plentiful of benefits could be derived by use of sensors to time-stamp and outline timelines of pertinent events, including ones stemming out of faults in machines. The data when treated and analyzed by learning machines will reveal reasons for time loss.

“IT’s INEVITABLE. EMBRACE IT.”

Indeed, IoT works wonders on OEE. So brace up your machines to let IoT splatter it bountiful of benefits. Dave Reiber, formerly of General Motors favouring IoT rightly states, “It’s inevitable. Embrace it.”

What to learn from the audit failures of Mylan labs?

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With the popular level of growth we learn a lot about the innovative application in any field in the process, so do we find lessons when we see any popular failure case. Such an audit failure case was reported by the FDA inspection against the Mylan Laboratories Limited from Maharashtra, during the period of September 5th to 14th, in the year 2016.

As per the FDA case reports of the Mylan lab audit failure, there were two different stages where the failure has occurred.

Let us learn in detail about the failures as well the measures that could have been the best, which now onwards can be used by the others before they produce the product, and by the quality management systems.

Failure #1

Mylan Laboratories Limited has neglected to altogether examine any unexplained error or failure of a batch or any of its segments to meet any of its determinations, regardless of whether the batch has just been conveyed (21 CFR 211.192).

Their investigation did not achieve an assignable reason, nor did they take fitting corrective actions and preventive actions to guarantee that the huge “analytic bias” to which at last ascribed the underlying failure would not influence other systematic work in their laboratory.

Because of the identified failure, the laboratory choices are to be made based on scientific assessment, and that they are to decide if OOS laboratory results are the aftereffect of the laboratory procedure or the assembling procedure.

Lesson to learn:

The reaction is deficient on the grounds that they neglected to execute a corrective action and preventive action (CAPA) plan to alleviate mistakes that you credit to laboratory process.

Failure #2

Mylan Laboratories Limited has neglected to set up a sufficient quality control unit with the specialist to survey creation records to guarantee that no mistakes have happened or, if blunders have happened, that they have been completely examined (21 CFR 211.22(a)).

Their quality unit neglected to screen and research blunder signals produced by the modernized frameworks that they use for elite fluid chromatography and gas chromatography. These signals demonstrated the misfortune or erasure of unique CGMP analytical information. In any case, their quality unit did not thoroughly address the mistake signals or decide the extension or effect of lost or erased information until after these issues were checked on amid our investigation.

Amid the assessment, our specialist saw that the Enable 3 framework review trial showed numerous cases of a “Project Integrity Failed” message, which demonstrates that infusions were absent from the aftereffects of analytical testing.

Lesson to learn:

The reaction is deficient in light of the fact that they have not distinguished and researched each case in which information obtaining has interfered. While they surveyed a predetermined number of mistake codes from a multi-day time span, they didn’t assess the impacts of other blunder codes recognized in the reenactment practice write about the unwavering quality, acuteness, or fulfilment of the information they used to assess the quality of their drugs.

What Is Lean Manufacturing And How it is Related To QMS

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Introduction

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.

How Values of Lean Manufacturing and QMS Overlap

Value

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.

Flow

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.

Pull

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.

Perfection

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.

Conclusion

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.

What are the stages of implementing a Quality System in Pharma Manufacturing

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Quality System in Pharma Manufacturing Like we have said before that Quality Management System in Pharmaceutical Manufacturing Industries is must have. In this Quality Systems management, there are different stages and necessity of each stage. These stages are independent and work as a benefit to the end product but severely interlinked with each other, that makes all the stages equally valid and important.

We will make you aware of the stages that serve mandatory in the implementation of Quality Systems in Pharma Manufacturing.

Let us talk in brief about the process and orientation of the available 9 stages, here.

Stage – 1

Generate templates for the controlled documents

All the templates must be written regarding all the controlling document types planned to be used. All these templates must contain consistent formats and styles which will make the documents very easy to navigate also to read.

Stage -2

Identify your company’s key processes, existing procedures, and management and control systems needed for the QMS.

Majority of the companies already bear written policies and procedures of some type. However, these procedures seem to be incomplete, if lacking out specific detail, it remained out of date, or if not merged with other business processes.

Stage – 3

Map the key processes and procedures so that their sequence and interaction is clear. Highlight any area that is missing a document that is required as part of the QMS.

To map the processes that are used to manage the quality structure, including the company’s own built sequence and communication with each other. Mapping simply looks similar to any flow chart. One must ensure that every stakeholder is engaged in this process; treat it as running a brainstorming session with multidisciplinary group members.

Stage – 4

Map needful document hierarchy structure with high level document contents for all types of controlled documents.

To organise the following document types:-

Procedures

Work Instructions

Forms

Lists

Quality Manuals

Stage – 5

Draft all the controlled documents upon the document maps.

All the controlled documents should be drafted according to the document maps. We must consider the root level audience for the document and make use of language and vocabulary that is both appropriate for the company and for the users.

Stage – 6

Manage electronic drafts and draft a Master Document List.

Companies suggest saving the files with a type of document identifier in the file name. This will ensure that versions and review moderation can be tracked and handled.

Stage – 7

Review the content of all QMS documents with subject matter experts (SMEs).

Be assured that all documents are investigated by subject matter experts (SMEs) from all the mandatory areas that are influenced by the extent of the record. Issuing a controlled document that influences any single area where staff have not had the chance to survey may cause superfluous contact, decrease consistency and increment the danger of deviation.

Stage – 8

Finalise the QMS documents for approval and issuing.

Plan printed copies of all documents, considered and acquire the suitable approval as managed by the compliance standard. Issued unique hardcopies must be documented in a safe area. Once the QMS documents are affirmed and are prepared to be actualized (issued), must save the electronic files as per your document control method utilizing the document correction number in the record name. Distribute the controlled documents (printed copy or pdf) as indicated by the document control strategy so staff can be prepared and utilize the documents.

Stage – 9

To go live! Train all staff on appropriate documents with respect to their training matrix.

This is when you should start your process of production after all the above steps have been implemented with the utmost details.

As you know that these methods are surely heavy to maintain and follow up. So it is considered to be more accurate if done using Quality Management System Softwares than doing these tasks manually.

Pharma 4.0 and impact in quality

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Pharma 4.0 and impact in quality The vision for Industry 4.0 is to associate all assets like human, data, and physical machines and all in one virtual system. This network is both inside and beyond organization walls; the most of the advantage will be accomplished by exploring beyond plant walls.

Industry 4.0 joins different innovations, including huge data examination and cloud computing. The capacity to break down tremendous data volumes and offer knowledge over the virtual esteem bind will be imperative to conveying new innovation and reacting to changing market elements. Substance and data are put away in a managed cloud archive so data can be gotten to continuously from anyplace.

By applying the ideas of Industry 4.0 to the pharmaceutical industry, “Pharma 4.0” is both progressive and transformational from the outbound stream of merchandise to the data flow back of continuous patient data.

Industry 4.0 as the assembly of individuals, physical systems, and data inside a modern procedure to expand quality, profitability and benefit by utilizing the intensity of cutting-edge data investigation. Pharma 4.0 can be characterized similarly.

It is depending on two factors:-

The numbering system utilized in software advancement.
The possibility that the Mechanical Revolution, described by automation and steam control, was Industry 1.0; the entry of power was Industry 2.0; the Web was Industry 3.0, and we are currently in the early stages of Industry 4.0 that is Pharma 4.0.

Its Impact on quality management systems:-

The pattern towards more individualized therapies implies greater quality data to survey and more discharges to help. With this comes more stress on quality to abstain from being the bottleneck in a make-to-arrange world.

Acknowledgement of Pharma 4.0, is something that requires a move in how GxP content and data are overseen. The present methodology is still incredibly in view of paper and a conventional meaning of documentation needs. This backs off procedures and is constrained with regards to effective information sharing and joint effort over different gatherings.

Change needs to begin with changing the attitude and impression of GxP content:

An electronic content isn’t simply ignoring paperwork – Numerous companies think they have cutting-edge execution systems, however, those systems still help paper-based preparing for GxP record-keeping. Looking forward, GxP-consistent documentation will emerge in new electronic arrangements, which can’t be legitimately made do with inheritance paper-based procedures.
GxP and non-GxP data administration will consolidate – GxP importance to records and systems will be characterized by use, not physical partition like various paper or document duplicates. This implies grouping as GxP or non-GxP won’t be active any longer, and this requires security instruments and controls for non-GxP cases.
Globally coordinated effort and substance trade are musts – The objective is never again to detach materials and data behind organization dividers, but instead to encourage a protected trade among a virtual group. Group set-up can change rapidly, and procedures may be reconfigured. So, it is essential to not just allow access to outside gatherings on a micro level, yet in addition to denying access in an adaptable and secure method.

The pattern towards customized treatments requires a change. One that backs the move from unyielding large-scale manufacturing to manufacturing separately custom-made items with the normal quality, safety and viability. A Pharma 4.0 methodology is expected to help this movement. Quality needs to order the evaluation of dangers and the execution of successful controls to open the ways to Pharma 4.0.

MAINTENANCE METRICS IN OEE

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INTRODUCTION

MAINTENANCE METRICS IN OEE In the manufacturing sector, world-over, machines have overwhelmingly taken over the production of goods. Machines, as we all know, are subject to wear and tear, and if not repaired timely, eventually, break down. To address the issue of maintenance manufacturing firms would benefit by adopting TPM to monitor their machines’ performance and condition. The preventive metric of OEE can be used as a tool by the management and workers to continually assess how well machines are serving their owners, in real time, and determine action for repairs as and when required.

PREVENTIVE METRICS IN CONTEXT OF OEE

OEE or Overall Equipment Effectiveness, a performance metric quantifies the efficiency of machines. It brings to visibility the entire factory floor, along with the machines and the various production processes in the production lines. Before we set appreciate the implications of preventive metrics, let first understand how an OEE system operates.

OEE provides digital data in the real time primarily by basing its calculation on 3 key elements of production :

Availability = (Operating time – Downtime) /Total Operating Time
Performance = Total output/potential output
Quality = Good output/total output

The TPM metrics is derived from the study and analysis of data provided by OEE on above 3 critical elements.

Advantages of the Preventive Metric

Reduces Downtime

One main feature of the OEE system that reflects TPM metrics is the Availability feature which captures Operating time, Downtime and Total Operating time. In the process, OEE helps in tracing a host of issues, including adverse machine conditions that cause downtime. The issues can be detected at the individual level, a cell or line level, or the whole plant level.

Tracing Equipment Fault in Real Time

The data provided by OEE reaches the minute levels of production processes, to show where a machine is at fault. Once fault is found, appropriate action can be taken, and thus, downtime be reduced. TPM metrics calls upon the unit to nip an equipment’s problem at the bud stage, so as to prevent problems from aggravating in the future.

Reduces Repair Costs

Preventive metrics drastically reduces your repair costs. Without OEE, the faults of the bigger and more complicated machines cannot easily be detected, more dso in real time. An interface of OEE with CMMS ( Computerised Maintenance Management System ) further aids the TPM system to take preventive measures promptly. Timely repairs could avert breakdowns causing downtime, and a significant loss for the firm.

The TPM metric could be checked from the Rate of Quality percentage as well. The rate gives comparative statistics on the acceptable parts produced versus the scrap. Since the preventive metric gathers data both at individual machine and line levels, it facilitates detection of faults at its root.

Case Study

The benefit of the application of maintenance metric can be seen in the case of GE Fanuc. The organisation had earlier sought to decrease its downtime duration by the use of engineering processes. It was successful in its endeavour, but not satisfactorily. Later when it switched over to OEE, GE application, the management detected plant’s bottleneck area – hundreds of brief line stoppages due to simple misalignment causing a dip in productivity were traced. Subsequently, when the firm took corrective measures, production spiked.

CONCLUSION

MAINTENANCE METRICS IN OEE When you have machines cranking out goods for your firm, don’t neglect their well-being. The solution indeed is to keep a quantified vigilance over their efficiency and productivity. And what better way to do so than using the maintenance metric under the arc of the OEE system.