@)LRQA LRQ Assurance Yusuf Khan V Kukad successfully completed the LRQA QMS Auditor/ead Auditor Training Course (based on ISO 9001:2008) (Approved IRCA QMS Auditoi/lead Auditor Training Course) on 19 ~ 23 September 2011 Certificate Number: 11/1683 Date Issued: 10th October 2011 LRQA Training do is sterYusufkhan V Kukad From: Yusufkhan V Kukad Sent: 07 March 2014 09:42 To: Vipin Anil Thormothe Subject: QstB Quality Systems eZ TOOLBOX Support ipport Index Resources + 180 9001 Timelin + Non-conformance + Corrective Action «Preventive Action + History of ISO 9001 « The six required procedures of ISO 9001 + Records required by ISO 9001 + Using Process Maps + Supplier Management © Control of Documents + Environmental Management Accounting ¢ ‘Training, Awareness, and Competence + Hierarchy of Controls Implementation and Ongoing Management _ Integrate Quality and Safety Management Problem solving with the 's Why 1 How’ technique Records for Safety Management Risk Management Management Review Meeting Tactics Planning for Quality - System Business Planning techniques Planning for Quality - Product / Service Calibration Internal Audits * Zero togoo1 © Zero to 9001- the pathway to ISO 9001 accreditation s, time, resources. ity Management System ng needs. eed! some more ink ). 9001 - 4. Gelling Started with your ISO 9001 Que 4. Managing people r 5. Managing Custom 6. Plan Logistic: 7. Managing Production or Service Delivery Processes 0000000 iive and Preventive Action © 9. Auditing © 10, Management Ri iow ‘ost of Poor Quality of Good Quali Hiring a ‘ime Quality anager ms - Paper versus Web Sump to: hat isa PROCESS MAP? ‘Toolbox, a complete online Quality Management System - no more paperwork !! Kindest Regards, Yusuf Khan c eng M Tech (Hawr) Dy General Manager ~Quality L&T Infrastructure Development Projects Limited, 9 Avenue, 2" Floor, Behind Rajpati Club, Sarkhej-Gandhinagar Highway , Bodakdey, ‘Ahmedabad -380059 (Gujarat ~India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: Yusufkhan V Kukad Sent: 06 March 2014 11:26 To: Shreebanta Kumar Das Subject: 150 9001 Timeline - Implementation and Ongoing Management ISO 9001 Timeline - Implementation and Ongoing Management Heres a timeline for implementing a new ISO 9001 compliant quality system, getting certified and the ‘ongoing maintenance through to re-certification. From the start of the project to the initial certification audit typically takes 6 months, The time taken depends on the resources committed to the project and the size and complexity of the organisation, and it can be as fast as 4 months. “Instant Certification” is not possible due the requirement for records that demonstrate use of the quality system. After the initial certification, the external auditor will usually revisit after 6 months for a surveillance audit. ‘Thereafter, external audits are conducted at least every 12 months, and sometimes every 6 months — depending on the business. After 3 years, a major re-cettification audit takes place to renew the ISO 9001 certificate. An internal audit is typically scheduled 2 months prior to each external audit. This gives you a chance to correct any problems prior to the external audit, Kindest Regards, Yusuf Khan c tngg Tech (Haw) Dy General Manager ~Quality L & T Infrastructure Development Projects Limited, 91" Avenue, 2° Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, ‘Ahmedabad -380059 (Gujarat -India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad Yusutkhan V Kukad (06 March 2014 11:18 Shreebanta Kumar Das Non-conformance Annon-conformance means that something went wrong ~ a problem has occurred and needs to be addressed. Non-conformances are addressed with corrective actions You may find a non-conformance in a service, a product, a process, from a supplier, or in the system itself, It occurs when something docs not meet the specifications or requirements in some way. Those requirements might be defined by the customer, a regulatory body, or in the internal procedures of the company, A non-conformance could be identified through customer complaints, internal audits, extemal audits, incoming material inspection or simply during normal testing and inspection activi 1SO 9001 requires that you document your non-conformance procedure (clause 8.3) and keep records of non-conformance issues you identify and the actions taken. Your non-conformance procedure will address how you deal with the problem: * how to decide on what immediate actions will be taken to correct the problem, and who is responsible for the decision. These immediate actions can be seen as “damage control” and need to: stop further non-conformance © assess the effects of the problem — how much, how bad (e.g. serap / rework), © contain the effects ~ e.g, quarantine defective items © notify affected customers, if necessary how reworked items should be checked (if different from normal inspection) how and where a non-conformance should be recorded what steps should be taken to identify any defective product released to a customer what, if any, concessions/discounts will be given to the customer how a decision will be made on whether further corrective action is necessary G usrion Kindest Regards, Yusuf Khan c Engg M Tech (Hawr) Dy General Manager —Quality L&T Infrastructure Development Projects Limited, 9 Avenue, 2 Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat -India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad Fro Yusufkhan V Kukad Sent: (06 March 2014 11:20 To: Shreebanta Kumar Das Subject: Cortective Actions Corrective actions are reactive — something has gone wrong and these are the actions taken to deal with the problem. Non-conformances are resolved through corrective actions. ‘This will include the immediate corrective actions you take to keep your customer happy, e.g. you sent the \wrong part and will immediately replace it with the correct patt However, ‘dealing with it’ for ISO 9001 means that you eliminate the problem AND make sure it will not happen again, so the corrective actions you take will also include the longer term actions you take to make sure the problem will not occur again. The problem might be identified in processes, materials, suppliers, the product, the service, the workplace, or the management system itself. ‘You might find opportunities for corrective actions through: conducting workplace inspections testing, inspecting, and monitoring of plant and equipment consulting with staff customer feedback audits hazard reporting dealing with any non-conforming product investigating complaints reviewing system failures reviewing regulatory requirements The ISO 9001 standard requires that you have a documented procedure for Corrective Action (clause 8.5.2) and you must also maintain records of corrective actions and their results, ‘The Corrective Action procedure will include the steps taken to: review and document the problem contain or temporarily fix the problem. e.g. remove the defective product from production and quarantine it in a designated area for later investigation Investigate the cause of the problem — how did it happen, why did it happen, could it happen again? Propose an appropriate solution that will prevent the problem happening again. This will often mean a change to the process. You need to report on what actions were actually taken. After an appropriate period of time, you will need to assess whether the actions taken were successful in preventing recurrence. Document the evidence to support your decision. Once you are satisfied the problem is not recurring, you ean close the issue. ‘The documentation for a corrective action provides evidence that the problem was recognised, corrected, and proper controls installed to make sure that it does not happen again. 1Yusufkhan V Kukad From: Yusufkhan V Kukad Sent: 06 March 2014 11:24 To: Shreebanta Kumar Das Subject: Preventive Actions ve actions are pro-active ~ something could go wrong and these are actions taken to stop it from happening, or to stop it from becoming too severe, In contrast, if something has alteady gone wrong, itis a non-conformance that is addressed with corrective actions, In order to identify risks that need preventive action, adequate monitoring and controls must be in place in the quality system (o assure that potential problems are identified and eliminated before they happen. If something in the quality system indicates that a possible problem may develop, a preventive action must be implemented to avert it and then eliminate the potential situation, You can identify opportunities for preventive action in a number of ways: ‘Through the management review process Process / Performance monitoring Analysis of warranty data and customer feedback for trends Process analysis Look for trends in the root causes of corrective actions Risk assessment, FMEA (Failure Mode Effects Analysis) — i.e. what could go wrong and what would happen if it did) Employee suggestions for improvement Contingency planning, Disaster recovery planning. Production planning Monitoring changes in legislation, regulations, Reviewing changes in the marketplace ‘Assessing new technology Internal / External Quality Audit Findings Employee Observation ‘Once you've identified a potential source of problems and the possible effects, you need to assess how likely itis to happen, and whether the costs associated with reducing the risk are worth it. It is effectively risk management, If you decide to do nothing, you will still need to document the reasons for your decision, 1SO 9001 requires that you document your Preventive Action procedure (clause 8.5.3). You are also required to keep records on Preventive aetions you've identified and the actions you took. When you write the procedure you need to keep in mind “say what you do, do what you say”. The procedute is the first part, and the records you keep prove the second patt. Your Preventive Action procedure will include information on: * How you identify a potential problem « Where and how it should be recorded + how the cause should be investigated, and by who 1«deciding on what action will be taken + howto record the actions taken «assessing the solution for effectiveness and documenting the evidence to support your decision. * when and who can finally close the issue ‘The records you keep on preventive actions you've taken, provide evidence that an effective quality system has been implemented and that it is able to anticipate, identify and eliminate potential problems. @ wren Kindest Regards, Yusuf Khan c Engg M Tech (Hawr) Dy General Manager ~Quality L & T Infrastructure Development Projects Limited, 9" Avenue, 2" Floor, Behind Rajpath Club, Sarkhe}-Gandhinagar Highway , Bodakdev, ‘Ahmedabad -380059 (Gujarat ~India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: Yusufkhan V Kukad Sent: 07 March 2014 10:08 To: Vipin Anil Thormothe Subject: 150 9001 - A Brief History and Overview ISO 9001 - A Brief History and Overview 1S0 9001 has evolved considerably since its inception and is now much more readily applicable to service sector type businesses and organisations than was originally the case. The standard started out as BS5750 and arose out of the need to Improve the quality of production line manufacturing, this being the predominant industry type in the UK in the 50s and 60s, This emphasis however eventually caused many problems with its interpretation and application to the service sector industries that arose in the 80s and 90s. The BS5750 name was dropped in 1987 in favour of the international standard, known since by its generic convention ISO 9000, and the use of The Standard then grew throughout many other industrialised countries as well as in the UK. A significant reason for the rise in ISO 9001 certifications in the UK has been the increasing demands by governmental type organisations and major civil engineering contractors etc. that their suppliers were ISO 9001 registered. Although meeting the Standard was intended to guarantee quality, this unfortunately did not always happen as 1S 9001 did not, in its earlier form, really encourage business improvement as such, and notably did not even say much about customer service; rather it was more a means of controlling conformance as well as the presumed nonconformities, It became normal for businesses to focus so much on the ISO 9001 requirements themselves that they missed the Point about meeting their customers’ needs and improving the quality of thelr products or services. It was not unusual for ISO 9001 to be seen as totally separate from the real day to day business operation, Sadly, examples of this misconception are still around today. Fortunately many of the earlier shortcomings were addressed in the significant Year 2000 update which moved away from just managing conformance to cover many of the wider issues concerned with managing a business, as well as laying greater emphasis on the key areas of customer focus, people involvement, and importantly, continuous improvement. ‘The most recent update to 1S0 9001 was in 2008 and the current version to which organisations are assessed is. 1S0 9001:2008, however the changes made in 2008 are quite minor and do not significantly affect the actual requirements; the changes being mostly to clarification notes. ‘There are in fact a range of standards within the ISO 9000 family, and one that is worth a closer look is 150 9004, Which is in fact a very useful guide to implementing ISO 9001, and can help users to understand more fully how to go about ensuring genuine continuous improvement. ‘The current revision of ISO 9001 is certainly more relevant to today's service sector industries, however the key to ensuring that 150 9001 delivers real business benefits and service improvements is in its implementation, Kindest Regards, Yusuf Khan c engg » Tech (Hawe) Dy General Manager -Quality L&T Infrastructure Development Projects Limited, 9" Avenue, 2" Floor, Behind Rajpath Club Sarkhej-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat —India)Yusufkhan V Kukad ——————— From: ‘Yusufkhan V Kukad Sent 06 March 2014 11:36 Te Shreebanta Kumar Das Subject: The six required procedures of ISO 9001 The six required procedures of ISO 9001 ISO 9001:2008 requires “documented procedures” for the following six activities: Control of documents (4.2.3) Control of records (4.2.4) Internal audit (8.2.2) Control of nonconforming product (8.3) Corrective action (8.5.2) Preventive action (8.5.3) Of course, these documented procedures will have to be controlled according to the first procedure listed (Control of Documents). Any more is up to you. You must determine what further documentation is required in your company for your Quality Management System to function effectively. 1SO 9001 also specifies required records G wrion Kindest Regards, Yusuf Khan c Engg m Tech (rawr) Dy General Manager ~Quality L & T Infrastructure Development Projects Limited, 9!" Avenue, 2” Floor, Behind Rajpath Club, ‘Sarkhe}-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat ~India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad Cnn ERIRIEEIEReemneieereeeeemeeeener eS From: Yusufkhan V Kukad Sent: 06 March 2014 11:40 To: Shreebanta Kumar Das Subject: Records required by 1SO 9001 1SO 9001 requires records to be kept on certain activities. Th des s part of proving that you ‘do what you say’. These records are also important for making fact-based mis on issues in your company. Here are the activities for which records must be kept: ‘Management Review Meetings ~ minutes (5.6.1) Training records (6.2.2) Product realization — evidence that requirements are fulfilled (7.1) Sales activities where the customer requirements are reviewed, including enquity & quotation, order receipt, order processing, order changes.(7.2.2) Design and development ~ inputs, reviews, verification, validation, changes (7.3) + Supplier Evaluations (7.4.1) re-validation of Special Processes (7.5.2) (processes where parameters are controlled e.g, temperature, rather than controlling the product) Unique product ID records — (e.g. serial / batch number) if traceability is required (7.5.3) Customer property — lost, damages or unsuitable for use (7.5.4) Calibrations (7.6) Internal Audits — findings and actions (8.2.2) Product checks ~ throughout process and for final release, including ‘who (8.2.4) ‘Non-conformances (8.3) Corrective actions (8.5.2) Preventive actions (8.5.3) Kindest Regards, Yusuf Khan c Engg ™ Tech (H&wR) Dy General Manager -Quality L & T Infrastructure Development Projects Limited, 9" Avenue, 2° Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, Ahmedabad ~380059 (Gujarat ~India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad Yusufkhan V Kukad 06 March 2014 11:45 Shreebanta Kumar Das Using Process Maps What is a PROCESS MAP? A Process Map is simply one way to provide a top-level view of the system documentation required fora typical 180 9001 quality management system, You don’t have to use process maps to be compliant with 1809001, but they are a very effective visualisation tool for the job. Process Maps can be easily extended when organisations seek additional certification to AS4801 / ISO 14001 / HACCP . The Process Map will in these cases provide an overview of the integrated management system. Clause 4.1, “General requirements of the ISO 9001 Standard” states that: ‘The organisation shall: 4) determine the processes needed for the quality management system and their application throughout the organisation, ) determine the sequence and interaction of these processes Note 1 of this clause says that you will need to include your processes for: * resource management - people and infrastructure + product/service realization — purchasing from suppliers, actual production, customer services, delivery, ete * management activities ~ planning, system review, document control * measurement, analysis and improvement ~ customer complaints, audits, corrective and preventive actions, ‘The Standard contains a generic model of a process-based quality management system that illustrates the process linkages of a typical organisation. However, this model is generally not easily interpreted by organisation ‘To help we have supplied you with a typical process map for a manufacturing-type company. ‘This map can easily be modified for service based companies or expanded to include safety or other compliance related processes.wots Rey: 0 SYSTEM MANAGEMENT - PROCESS MODEL Bata: 08.9 area PRODUCT SERVICE PROCESSES (RMP) REALISATION PROCESSES (P/SRP) CONTINUAL DRECTIVES IMPROVEMENT ‘ugewenr syst Vewonwnce oat @ srr Kindest Regards, Yusuf Khan c Engg M Tech (Hewr) Dy General Manager -Quality L & T Infrastructure Development Projects Limited, 9" Avenue, 2” Floor, Behind Rajpath Club, Sarkhe}-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat —India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad Yusufkhan V Kukad 06 March 2014 12:40 Shreebanta Kumar Das Supplier Management Supplier Management ISO 9001 says that you should evaluate and select suppliers based on their ability to meet your requirements. You have to define the requirements that are important to your organisation, and select suppliers on those criteria. The list of approved suppliers is part of your quality management system. Evaluation Criteria Obviously cost is an important criteria for selecting a supplier, but it shouldn't be the only factor — or even the most important one, A reliable and consistent supplier is worth paying extra for, since the less variation coming into your process, the easier it is to keep consistent results. It’s not just the product you need to think about — Consistent lead times, good customer support, delivery, and business stability ate important too. 1SO 9001 does NOT say that your suppliers need to be cei still evaluate their performance. ied to ISO 9001. Even if they are, you should Evaluation Methods Some companies use a questionnaire form with new suppliers. Another common method is to place a few trial orders to make an assessment. For existing suppliers, you will need to periodically re-assess whether your suppliers are still meeting your needs. To evaluate suppliers based on their past performance, you'll need to keep records (e.g, an Incoming product inspection log, records of supplier non-conformance). If you cannot fulfil your customer's needs without a particular supplier, then it’s a good idea to include a risk assessment in the evaluation ~ go through the “what if” scenarios and develop backup plans: What ifthis supplier could not deliver for 2 weeks or could not meet several shipments in a row? What would happen if this supplier went out of business? How much time you spend evaluating a supplier will obviously depend on how important they are to the quality of your produet or service, and the value of the purchase. How you decide which suppliers need to be assessed and how you assess them should be included in your purchasing process documentation. Building Relationships Supplier management also means communicating with your suppliers and providing feedback on their performance, They'll need to know what is important to you and where you'd like them change or improve. If your business is valuable to them, they are more likely to be responsive. ‘You'll be looking for simliar feedback from your own customers. Improving these supply chain relationships will contribute to your own continuous improvement @ wron Kindest Regards, Yusuf Khan c Engg ™ Tech (HawR) Dy General Manager ~Quality L& T Infrastructure Development Projects Li 9 Avenue, 2° Floor, Behind Rajpath Club, Sarkhe)-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat ~India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad a From: Yusufkhan V Kukad Sent: 06 March 2014 12:03 To: Shreebanta Kumar Das Subject: Control of Documents Control of Documents Document control is core to ISO 9001. “Documents required by the quality management system shall be controlled.” ‘That “shall” word in there means you have to do it, Here it is again: “A documented procedure shall be established to define the controls needed” This “shall” word makes this one of the six procedures that you must document. ‘So what are the “controls needed”? Answer these questions in your documented procedure and you'll satisfy the requirements for ISO 9001 Document Control: How do you approve documents for release? — who approves them? How will I know a document has been approved’? How do you review, update and re-approve documents? Do you review on a regular basis? (you should) Who does the review? Who is responsible for making changes? How is an updated version approved? How do you identify the changes that have been made and how do you identify the revision status? — How will I know what has changed between this version and the latest release? How do I know what version my copy is, or the version of this paper copy I found? How do you provide access to the correct version where it’s needed? e.g, on the shop floor ~ Are there hard copies to update? How do you keep track of them’? Who is responsible for distributing or updating to the latest version? How do you find and control documents from external sources? e.g, relevant standards, legislation, supplier product specifications. ‘Control’ being all the previous questions on approval, review, updates, access... How do you prevent the use of obsolete documents? How will you make sure that ONLY current documents are in use? Will you make end users responsible for checking the status before each usc? Will you delete/destroy old documents? How will you identify/segregate/archive obsolete documents you might ‘want (0 keep? Enough with the questions — how about some answers! So what do you need to do, in a practical sense, to control documents? #1 — put some control information on the document itself — on every controlled document. 1Some information will go at the front of the document, and some needs to be on every page (ustally in the footer), Here's an example of a basic header: Title 4.2.3 Control of Documents Person Responsible Management Representative Date Last Updated 3 March 2012 Status Released. Location Quality Systems Toolbox ‘This header shows what document I’m looking at ('4.2.3 Control of Documents’), and answers the questions on how to tell this document has been approved (‘Released’), and the version (‘3 March 2012"), who is responsible for approving it (‘Management Representative’), and where to find it (‘Quality Systems Toolbox’) Here’s an example footer showing information that should be on each page of the document 4.2.3 Control of Documents Revision Date: 3 March 2012 page 1 of 2 Why on every page? + the number/name of the document ~ so you know what it is and can find the master copy, even if the first page is missing. Some people use the file path or URL of the master copy. e.g. “G:\Documents\ControlDocuments.doc”, or “https://demo.qualitysystems.com /documents/control-of-documents” + the revision date or number — so you can easily check to see whether the copy you have is the latest, even if the first page is missing, or your different (paper) versions get mixed up. + page numbering “page x of y* ~ so it is easy to see if you are missing a page #2 Nominate a single place to keep master copies and a register of documents This is where end users will go to check whether the version they have is the latest version. It may also be the place where they access the documents they need. In the past, this would have been paper master copies kept in the office, or on the document controller's hard drive. Access to the documents was through a ‘gate keeper’ person. More commonly now it is a file server, or online (e.g,, for Quality Systems Toolbox) and access is granted through user accounts, permissions and passwords. ‘The documents register is simply a list of all the documents you control, You'll need one to keep track of all your management system documents and it helps you to know what needs to be reviewed. Ideally the register will include the title, revision info (date or number or both), status (draft, released, ete.) and who is responsible for the document (a name and/or a job title). eB 4 Revision Revision Document Number Title Number Date Owner Status MSP-o1 General Requirements 2.0 13 March 2013 Jill Jones Released FORM- purchase Order 1.0 6Sept 2008 Bookkeeper Released o1POL-03 Poe 3.0 22 June 2011 WHSO Released POL-04 ee 06 5 May 2013 Michael Draft Paper-based registers are hard work ~ each time Pe ia es ja ia lcs grees = often striking out the old line and adding a new line. Spreadsheet based registers are not much easier to maintain but at least they allow sorting and searching. Online database document systems are easier, since updating the information stored with the document itself should flow through to the register, and sorting documents, searching and creating custom lists (e.g. show all ‘forms’) are usually possible, #3 Establish (and document) the process ‘This is where you answer those other questions Approval: Approving new and edited procedures is best spread around, and approval by the process owner makes the most sense ~ e.g. the Sales Manager will approve sales related processes. Management system documents (like the procedure for document control), will be the responsibility of the Management Representative. The actual editing of the document may be delegated to someone else. ‘The process of releasing a new document or update can be as simple as making the document available at the designated central location either adding it to the repository or changing the permissions to make it available. Notification of the new release to relevant people is usually a good idea, but be wary of sending every new document notification to everyone in your organisation ~ too many notifications means they will all be ignored, It is good practice to have some indication on the document itself so that the status of hard copies can be casily determined, e.g. ‘Released’ in the header example above, an approval signature and date added to the footer of a master paper copy. Review: You need to review documents regularly to make sure they are up-to-date, suitable and still reflect yout practices. If the practice has changed (for the better) then the document should be updated, rather than enforcing the old practices from the out-of-date document, Your review will include checking for changes in standards, regulations, specifications and other external documents. How often will depend on the process — how important itis and also how new and changeable it is. Some documents have regulations stipulating how often they must be reviewed e.g. MSDS must be less than 5 years old, Some of this will be incorporated into Internal Auditing and Management Review, but make sure all your documents are covered (check the document register), Changes: In file-server and paper-based management systems, changes are usually tracked in a table on the document itself. Sometimes this can be stored external to the document in the register. Document Management software will usually store the change information in the database, and a changes table is not required on the document itself. ‘The document itself should indicate it’s revision status (on the hard copy). Access: These days, access is usually via logging on to the file server or online document repository. However, don’t assume this is enough for all situations. The practicalities of accessing the computer may be difficulvimpossible for some locations or some personnel and you may have to distribute hard copies in these cases. Keep track of where hard copies go for future reference when updates need to go out and you need to remove the obsolete versions.External Documents: Finding new extemal documents required for your business will come about during normal operations as well as through management review, Control processes are the same as for internal documents. Obsolete documents: Keeping a distribution list for hard copies will help you track down the old copies ‘that must be removed. I's also common to put the onus on the end user to check their version against the version shown in the document register or the current version in the central repository Kindest Regards, Yusuf Khan c eng m Tech (Hawe) Dy General Manager ~Quality L&T Infrastructure Development Projects Limited, 9! Avenue, 2" Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, ‘Ahmedabad -380059 (Gujarat ~India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad Yusufkhan V Kukad 06 March 2014 12:41 Shreebanta Kumar Das Subject: Environmental Management Accounting Environmental Management Accounting Also known as Material Flow Cost Accounting (MFCA), this accounting technique is an environmental ‘management tool that uses detailed analysis of process inputs and outputs to accurately quantify the material and energy costs associated with waste as well as end products Inputs include: * Material costs (including major materials added at the beginning of the process, extra materials added during midstream processes, and supporting materials such as detergents, solvents, catalysts, cooling water, ete) «System costs (including labor, depreciation,... ~ typical “overhead” costs) + Energy costs (Electricity, fuel, utility) + Waste treatment costs (waste collection fees, disposal fees, sewerage costs, waste transportation) In contrast to traditional cost accounting, where waste costs are often hidden in various overhead accounts, MECA applies energy and materials costs both to “positive” product output and “negative” waste output from each process. Once the true cost of wastes are accounted for, companies often find that reducing waste is a better option than increasing waste recycling. This has a double benefit for both environmental and financial performance, reducing both waste and consumption of resources, Armed with good information on where waste is generated, companies can better target investments to improve their processes, This means that MECA analysis of processes is also a good tool for prioritising projects aimed at improving quality, Example: ‘This process takes 100kg of input materials and results in 80kg of product. Costs attributed to this process include materials ($1000), labour and tools ($1000), and electricity ($500). Waste disposal fees are $200. Traditional accounting would conclude that waste costs are $200 and all other costs are assigned to the production costs for the 80kg of product, Materials Flow Cost Accounting (MFCA) ssigns all costs proportionally to both product and waste, INPUT - OUTPUT — product OUTPUT ~ waste (ookg) (80kg) (20kg) Materials $1000 $800 $200 Processing, $1000 $800 $200Energy $500 $400 $100 Waste(dsposal gq $200 TOTAL $2700 $2000 ie Which reveals the true cost associated with the 20kg of waste is $700, and there is a bigger incentive to reduce it. More resources: A new standard has just been released (March, 2012); ISO 14051:2011, Environmental management — Material flow cost accounting - General framework Here's an introductory presentation on MECA (pdf) from the Ministry of Economy ‘Trade and Industry Japan (in English), with some Japanese case studies. And also a “Guide for MFCA” with more details, EPA Victoria, in conjunction with Environment Australia and ‘The Institute of Chartered Accountants in Australia (ICA), conducted an Environmental Management Accounting (EMA) Project. The report includes an good introduction to Environmental Management Accounting and follows through 4 Australian case studies from different industries Kindest Regards, Yusuf Khan c engg m Tech (Hawe) Dy General Manager -Quality L & T Infrastructure Development Projects Limited, 9" Avenue, 2" Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, ‘Ahmedabad -380059 (Gujarat —India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: ‘Yusufichan V Kukad Sent: 06 March 2014 12:25 Te Shreebanta Kumar Das, Subject: Training, Awareness & Competence In general, the standard states that “Personnel... isn't it? shall be competent...”, which is a bit of a ‘no-bi Ialso includes a note to say this includes tasks that indirectly affect whether the product meets requirements, such as any involved in the quality management system. This means that when you are determining needs, providing training, and keeping records, you need to include the requirements of the quality management system as well as the product or services you provide, ‘The specific requirements are to: a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence, ©) evaluate the effectiveness of the actions taken, 4) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and €) maintain appropriate records of education, training, skills and experience. ‘Those first three look very familiar: a) plan, b) do, c) check Not terribly difficult. Just work out what you need, see what you have, and then fill in the gaps. Check to see itis working, and keep records to show you do it. This misses d) which is about making sure people know how their activities fit into the whole scheme of the business and its quality management system. As far as IS09001 is concerned, you don't have to document the process — you just have to do it and keep records to show that you do, (But you can document it you want to and an overview of the process can be helpful.) Work out what you need It's very common to think about this when you write a job advertisement. You can use this mindset when writing job descriptions and determining competency requirements. Start with the responsibilities of the role and then think about what skills are needed to fulfil them, You'll need to add in requirements that wouldn't normally be included in a job ad, like knowledge specific to your organisation that’s provided in on-the-job training or induction, e.g,, “Awareness of our Quality Management System”, If you're starting from scratch, one approach is to ask everyone to describe their own duties, and what skills are needed — just make sure you tell them why, so they know you're not trying to replace them! You can then pass those descriptions up and down a level on the organisation chart to get a different perspective on the expectations for that roe, Knowing what you are expected to do makes it easier to know when you are doing a good job, and that increases employee satisfaction,See what you have Education, training, certificates, licences, experience, skills, awareness,... you'll want to have records for these, This is obvious when you are bringing in a new hire and filling out a new personnel file, but you'll need to have a way to track this for your existing employees whose knowledge increases over time with experience and training, tis common to add these kind of records to a personnel file, but this doesn’t allow you to get an overview of the assets and gaps, and tracking expiry dates is nigh impossible. Adding these competencies to list, spreadsheet or database will make life easier, Fill in the Gaps Gap Analysis is where you compare the ‘needs’ to the ‘haves’, and find the holes. This is pretty straightforward when there's not too many employees and not to0 many competencies, but it can get quite tricky as the numbers increase. ‘You can use a database (e.g., Quality Systems Toolbox), spreadsheets, or a simple table: Water collector tasks Jack Jill operating the well x x manual handling x first aid x Here's an example of a table “Responsibility Matrix, ‘Training Needs Analysis” included in the Environmental Management System Tool from the Australian Department of Sustainability, Environment, Water, Population and CommunitiesRole Position | Name Responsibilities ‘Gualfications! | Walning nee oi TiteMPosition no. ‘competency [< Director Toe Taylor |W Participate in Managamant ‘Sonior Businoss | EMS awaronass | | reviow Administrator | (in house) @ Sotting Potcy roviowing Objective & Targots 1 _Resource allocation Envronmontal | Jano Dawos |) Parlcipato in Managamant | Carifeate of —| Rolaahar EMS |? ‘Managor roviow Attaimment in| traning 4 (Manogoment @ implomenting omirormontas | Envionmontat | (Extemnap roprosentativo) policy Morogoro B Inpiomenting programs tor —_| Systems (1 achioving sot objoctivos & | 14001) targots Monitoring and measurement of environmenta! performance D Ovor alt resporsibity for systom ‘implomentation Internat Ruditor | John Sra | (@ Covoloping internal avai Gariiod EMS Awarenoss | program in Haison wih Facity | (RABQSA) toad | (in house) manager audttor , @ Conducting informal avdts as Auditing Course por schodulo ]_Tralning otnor internal auitors Waste MaryRane |e} Dovoloping waste managomari | Factory Managor | Wat 7 Managemont stratogy and implementation mioinsotion/ | + Coordinator procadures managomont @ Montering and moasuromont pringptos ‘Once you've identified the holes, make a plan for filling them, This doesn’t have to be lots of dollars spent on formal external training, Other methods are perfectly acceptable: internal training, classroom, on-the-job instruction, adhoc/informal, mentoring, ... Whatever works for you. Just keep records, which is easy for formal training, but a bit harder to remember to do for informal methods. Check to see it worked ‘Training does not necessarily equal learning Adult Education specialist, Hadiya Nuriddin at www.examiner.com, gives a great example: “Ihave received over 20 hours of cooking instruction and it may shock you to learn that Iam still not a great cook. How could this be? I showed up and completed all the assigned tasks. I nodded, smiled, and laughed on cue, And yet, whenever I cook a meal, a real chef somewhere dies inside.” and has some good tips on ‘How to get more learning out of training’. You will need to assess whether the training you provided, whether it was internal or external, has been. effective in closing the gap you identified. In some cases this assessment be provided in the form of a licence or certificate from the external training body. For internal training you can use other methods: + Direct supervision of work by a competent operator, + Extra inspection of the employee's work, * Awritten test after the trainin; * Apractical test after the training, * acombination of the above,Particularly for external training, Hadiya Nuriddin suggests that "managers and employees should discuss the course and what was learned. This does not mean asking how the course went and accepting, “Fine,” ‘an answer. It means having a meaningful discussion about how the material contributes to the employee’s and the company’s success." Awareness This seems to be the fuzziest one, but it’s not really. Awareness is something that employees need to know and would usually be part of the initial job orientation/induetion, For some activities it won't be obvious how they affect the customer and on quality management, or affect safety or environmental impacts. Having aan overview of your processes (e.g, a process map) and top level process documentation can help define where the activities fit. Awareness of the quality/safety/environmental management system is usually is taken care of by in-house training that should include: + the quality / safety / environmental policy, «significant quality / safety / environmental aspects of their activities and related work instructions, * objectives and targets, + their quality / safety / environmental management system roles and responsibilities, «safety / environmental emergency action plan, + where/how to access information, = howto report incidents, + how changes can be requested (e.g. a document change request) + how updates are posted, Changes occur and people forget, so don’t restrict awareness training to induction, Records If you are managing training then you'll have the following records: - + written job deseriptions and their competencies, « paper or electronic copies of licences, certificates, training records, ete, and also the listing you created, + meeting notes with attendees listed (e.g., for a safety briefings), «the gap analysis (table / list / matrix), + training dates (a plan, a calendar), and * training records once training has been completed. (All managed according to your written records management procedure). Rinse and Repeat Roles and responsibilities change over time and employees develop new skills, so you will need to repeat the analysis periodically. Conducting regular Performance Reviews is one method. Also, new needs can arise if the business decides it wants (o offer new services, has changed the way things are done (e.g., changes to a process, new software systems), or there have been changes to regulatory or customer requirements. If not otherwise, these changes are likely to come up as part of Management Review.Yusufkhan V Kukad Fro Yusufkhan V Kukad Sent: 06 March 2014 12:27 To: Shreebanta Kumar Das Subject: Hierarchy of Controls Hierarchy of Controls ‘The “Hierarchy of Controls” should be used at all times when implementing controls to eliminate the hazard or reduce the risk of a hazard causing loss / damage / injuries, ‘The hierarchy of hazard controls is a list which emphasises controlling a hazard at the source, is done by giving preference to the use of the ‘engineering controls” outlined in strategies 1 to 3 below. These types of strategies should be used, where possible, because they are less subject to human failure and because they are less disruptive and uncomfortable for people working in the area Back-up controls (such as PPE and administrative controls) should only be used as a last resort or as a support to other control measures, In many cases, it will be necessary to use more than one control method, Whichever methods you use, regular monitoring is important to to make sure that the control is working effectively and that exposure to the hazard is reduced or eliminated, ‘The hierarchy of controls is:Hierarchy of Control Apply the highest level of control commensurate with the risk level- lower value controls may be used in the interim until long-term controls are implemented. tere cu} Increasing participation and supervision needed Elimination: Obviously the most effective method will be to remove the hazard completely, if it is possible. Substitution: Replace the hazard with a lesser hazard. Be careful (o assess what new risks the substitute may pose. Engineering: Make changes to the process, equipment or plant to reduce the hazard. e.g. change to ‘wet? processes to reduce dust, enclose or isolate the hazard, install ventilation systems. Administrative: Establishing policies and procedures to mini exposure, posting hazard signs, restricting access, training, ise the risks, job scheduling to limit Behaviour: Following safe work practices, workplace good housekeeping, personal hygiene practices, PPE: Personal Protective Equipment provides a barrier between the wearer and the hazard. PPE items include respirators, safety goggles, blast shields, hard hats, hearing protectors, gloves, face shields, and footwear, G eerion Kindest Regards, Yusuf Khan c éngg tech (HgYusufkhan V Kukad From: Yusufkhan V Kukad Sent: (06 March 2014 12:54 To: Shreebanta Kumar Das Subject: Integrate Quality and Safety Management Integrate Quality and Safety Management ‘The requirements for a safety management system closely match the requirements for a quality management system, albeit with a different focus. The samte tools and processes you use to manage quality also apply to safety (and environmental) management systems ~ documentation and document control, incident/non- conformance reporting, maintaining records, managing training, maintaining equipment. (PS: QSToolbox is. designed to manage it all!) Scope and Policy For both management standards, you must define the scope of what the management system will cover and both require a policy. Each type of policy must be appropriate to the organisation, include a commitment to continual improvement, and be available and communicated to the people in your organisation. Having a safety policy that is “appropriate to the organisation” means that your policy reflects the type of hazards and risks associated with your activities. The safety policy must also declare a commitment to complying with relevant health and safety regulations, Incither case, the policy provides a basis for establishing objectives, and must be reviewed periodically to cenisure itis still appropriate, Planning In terms of safety management, this means you haye a process in place to identify and control risks and hazards, and you have process to identify legal requirements,In a quality sense, the focus shifts to determining customer requirements for the product/service but regulatory requirements are also included in the quality planning process. Setting objectives and targets and having a plan as to how to achieve them is common to both management standards. This is not surprising, since the process is common to setting and achieving other kinds of business goals. Targets need to specific and measurable so that you are able to monitor your progress in reaching them. Plans should also be specific as to who's responsible and when these objectives should be achieved. Obviously both objectives and plans will need to be reviewed and updated regularly. Implementation Both management systems refer to providing sufficient resources (financial, material, and human) to mplement and maintain the management system. Roles, responsibilities and accountabilities for the safety and quality systems also need to be defined — typically in organisation charts and job descriptions. Each standard requires a management representative (could be the same person) who is responsible for implementing and maintaining the system and reporting back to “top management”. Part of ‘implementation’ includes determining training needs, providing training (internally ot extemally) and managing training records. This includes safety related training, training for specific job tasks and also training for the management system itself. Similar requirements for training and competency are detailed under “resource management” in the ISO 9001 quality management standard, Consultation is specifically listed in the safety management standard, requiring that employees be consulted in health and safety matters. Communication to internal and external parties are part of both quality and safety management and, consistent with its focus, the quality standard specifically refers to customer communication, ‘The safety standard lists specific reporting requirements: system performance (audits and reviews), incidents and non-conformance, hazard identification, risk assessment, preventive and corrective actions, and any statutory (legal) requirements. These are not so different to the input requirements for management review in the quality standard which include: audit results, customer feedback, process performance, product conformity; corrective and preventive actions, changes that affect the management system. (including statutory changes), and improvement recommendations. Both systems require that you document core processes and how they interact (e.g, with a process map). ‘They also both require that there are systems/procedures in place for document control which cover document access, changes and approvals, version control, review, and preventing the use of obsolete information, The safety standard requires an organisation to have emergency response procedures in place. In a quality system this could be considered equivalent to ‘control of non-conforming product’, ie. what we do when things go wrong,Measurement and Evaluation the requirements are essentially the same, with a differing focus. AS4801 asks for measurement, monitoring and evaluation of hazards and, if necessary, health surveillance. For quality management the focus shifts to monitoring the processes and the product, with the same requirement for maintenance and calibration of measuring equipment. Incident reporting, along with preventive and corrective actions can be found in both standards, as can the requirement for controlling records, ‘Management system representatives for either standard would be familiar with the requirement for auditing. Management Review Finally, ISO 9001 and AS4801 both require that management take a look at their safety/quality system to evaluate whether itis adequate and effective, and to identify where change is needed Qusren re . Kindest Regards, Yusuf Khan c eng Tech (Hawe) Dy General Manager ~Quality 1 & T Infrastructure Development Projects Limited, 9" Avenue, 2! Floor, Behind Rajpath Club, Sarkhe}-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat ~India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad Yusufkhan V Kukad 06 March 2014 12:51 Shreebanta Kumar Das Problems solving with the 'S Why 1 How’ technique Problems solving with the '5 Why 1 How' technique (8) Why ~ (1) How .... is a simple tool which addresses single-problem issues rather than complex broad organisational issues. It attempts to analyse a problem or issue by asking a series of “Why (did this happen)?” questions followed up by an attempt at addressing the Root Cause of the issue by asking (1) How (do we fix this problem once & for all?"), ‘The technique was originally developed by the Toyota Motor Corporation and is an important technique for problem solving, ‘The architect of the Toyota Production System, Taiichi Ohno, described the 5 whys method as“... the basis of Toyota’s scientific approach ... by repeating why five times, the nature of the problem as well as its solution becomes clear.” 5 Why Analysis Training Boye dar Worn Belt Know To Swine Change « us Belt ‘Why? Slipping Didn’t nya Charee Dead Battery Car Won't Start Example: (Ast Why) Why is there oil on the floor under the press? A quick look found that the main return hose was leaking. (2nd Why) Why is oil leaking fom this hose?After further investigation it was found that the hose is rubbing on a fan belt and had worn through. rd Why) Why is it rubbing on the fan belt? More investigation found that the fan belt housing was loose. (4th Why) Why is the fan belt housing so loose? Afier another check we found some of the bolts that hold the housing in place are not fully tensioned. (Sth Why) Why then are these bolts loose? Nobody had serviced the press for over six months. (This is clearly the ROOT CAUSE of the problem.) (1) How ~ How do we fix the problem? ‘Typically, this answer is a mixture of Immediate Corrective Actions: Replace the hose and fan belt Remove broken bolts on fan belt housing and replace with new ones ‘Torque all bolts to proper specificatioy Preventive Action(s) Check bolt torque regularly Introduce a documented, preventive maintenance programme Monitor the maintenance programme for effectiveness ‘Our example in this instance included (5) whys. The number of why's is much less important than finding and fixing the root cause of the problem at hand. Kindest Regards, Yusuf Khan c eng M Tech (Hawe) Dy General Manager ~Quality L&T Infrastructure Development Projects Limited, 9" Avenue, 2° Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat India) Mo. +-919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: Yusufkhan V Kukad Sent: (06 March 2014 12:59 To: Shreebanta Kumar Das Subject: Records for Safety Management Records for Safety Management How do you (and your auditor) know your safety system is really working? Evidence. Here are some of the records you should be keeping. Hazards and Risks ‘A working safety system will have documented risk assessments you've conducted, and evidence they are reviewed periodically (e.g., review notes, meeting minutes) and updated (document change requests, new versions). You may also have records of employees being trained in risk management, If controls were recommended in response to a risk assessment, you'll need to prove they were put in place (c.g. updated safe work method statements, records of training in the new procedure) and records that show you monitor them (e.g. inspection checklists, internal audit reports, mecting mimutes). If there have been cases where the procedure was not followed, you'll have record of process non-conformances, Monitoring ‘You'll have records from: * monitoring the safety of your plant and equipment through maintenance and inspection activities (e.g, testing and tagging records, inspection checklists). * process and environment monitoring to ensure the safety of the product (e.g. HACCP for food safety) and to ensure the safety of your workers (e.g,, levels of noise, dust, gas, heat, fumes, radiation, etc). + checking that your workers are following the correct procedures (random inspections, internal audits, meeting minutes) + health monitoring for your employees, if necessary.Training This is a big one. You must maintain training records for safety training, competency training, training in new safe work methods, and records of your inductions which must include what information you cover. Training records will come from external training, intemal training — including on-the-job training and training conducted within meetings, training on plant and equipment, on work methods, emergency procedures, use of PPE, etc You'll need a system to make sure you can access those records when required. Maintaining training records will include keeping track of ex, assigned to a job have the necessary competencies. yy dates andl making sure that the workers Don’t forget that you will also need to ensure that your subcontractors have the right skills and training too. Managing training, awareness and competency is also a part of the ISO 9001 quality management standard, Communication A safety system is not functional without communication, You'll need to show how workers access the information within the system, e.g. safe work procedures, MSDS, health monitoring records, etc. This might be through logging in to a web-based system like Quality Systems Toolbox, a shared network file system, ‘an intranet, or a paper-based system. Evidence of communication also includes memos, minutes, emails, and safety toolbox meetings that inform employees and subcontractors of newly identified hazards, new controls for new or existing hazards, and also of recent incidents. For smaller groups, diary notes on verbal communications could also be evidence. The notes should include what topics were covered and who was present. Depending on the organisation, you may need to make provisions for communicating to workers who do not read very well, and/or workers with a limited understanding of English. ‘You will also need to show how workers communicate safety matters back to management, e.g, incident reporting, consultation, document change requests © von Kindest Regards, Yusuf Khan c €ngg M Tech (awe) Dy General Manager ~Quality L&T Infrastructure Development Projects Limited, 9 Avenue, 2° Floor, Behind Rajpath Club, Sarkhe}-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat ~India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: Yusufkhan V Kukad Sent: 06 March 2014 13:11 To: Shreebanta Kumar Das Subject: Risk Management ——- Unacceptable Ri Accoptable Rick levels Likelihood of Occurrence tow Madu ~ High Consequence Managing risks is something we all do every day, mostly without even thinking about it, When it comes to risks faced by a business, a more formal approach is needed, Different risks need different assessments in terms of the questions to ask, but the process is the same. A generic risk assessment process has been set out in ISO standard 31000, The guidance can be applied to any kind of risk by any kind of organisation. Essentially, the steps are as follows: * Establish the context — what activities are we talking about? © eg.,a piece of machinery, a process, a natural disaster, exporting goods, staff, data + Identify risks — what could go wrong? © eg., entanglement, pinch injury, collision, dust, noise, chemical exposure, flood, theft, fraud, + Analyse them — what could happen if it did go wrong? How likely is it? © minor injury, permanent impairment, loss of life, loss of reputation, economic setback, business closure... « Evaluate ~ can we live with this risk? 0 minor inconvenience? major problem? + Control/treat ~ what are we going to do about it? © _use the hierarchy of controls to decide, and consider the cost/benefit balance. * Monitor/review — is the control working? Can it be better? The resources below include many example risk assessment forms that follow the generie process, Some organisations have developed specific forms for the different kinds of hazards they deal with, to make it easier to remember to ask all the relevant questions. Looking at past incidents will also help you become aware of the different kinds of hazards to look for.More resources on Risk Management: (pdf) and also a Workplace Health and Safety QLD has a general Risk Management Code of Prac’ specific risk management program for Manual Tasks (pdf). For examples of what can go wrong and motivation on making your workplace safer, browse through the prosecutions and enforceable undertakings resulting from past safety incidents. Safework Australia has several draft Code: Risks (pdt. of Practice including one on [ow to Mania \www.ourcommunity.com.au has help sheets on cach risk management step from a community organisation. point of view, but there's good information in there for businesses too. AUSTRAC gov.au (whose purpose is protect the integrity of Australia’s financial system) has an e- tool with this module on risk manages For some Hazard specific risk assessment forms, take a look at the risk assessment section of the safety site for the University of Melbourne, e.g, Plant (pdf), Manual Handling (pdf), Chemivals (doe). ooks al Export risks including political, legal, corruption, financing, quarantine risks. Austra ‘The Victorian Department of Education has a bunch of completed risk assessn il equipment, Kindest Regards, Yusuf Khan c engg ™ Tech (Hawe) Dy General Manager ~Quality L & T Infrastructure Development Projects Limited, 9 Avenue, 2° Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, ‘Ahmedabad -380059 (Gujarat ~India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad ——— ee From: ‘Yusufkhan V Kukad Sent: (06 March 2014 15:42 To: Shreebanta Kumar Das Subject: ‘Management Review Management Review Management Review mectings are an important opportunity to bring together an overview of the ‘management system, to assess it’s performance, and to identify any opportunities where it can be improved. Held at least once per year, it’s also a time to review the company’s quality policy and set new objectives for the coming year. It's essential that “top management” be involved, ‘The agenda should include a review of: + internal and external audit findings and reports * customer feedback ~ look closely at the negative feedback, but don’t leave out the positive feedback ~ it’s valuable data too (and nice to hear!) + supplier performance * _allissues raised or resolved since the last review to make sure problems are being resolved properly, and to look for trends in the data + process performance ~ is the process reaching/maintaining performance targets? * any changes to standards, regulations, technology, competition, staffing, and other business activities that could affect the quality system + improvement requests ‘To be effective, attendees need to come to the meeting prepared with data, and be ready with some conclusions drawn from the data, It Looks like a long list (!) but there’s no reason you can’t break it into smaller chunks, and if you review some aspects in other meetings there's no need to repeat it, In fact, ‘Management Review" does not even have to happen in a ‘Management Review Meeting’. You will need to make sure you have records that show you have covered everything, however you do itAt the end of the management review process you will need to record any decisions and actions to be taken to improve the management system, produet, and/or processes, and what resource needs have been identified. Quality Systems Toolbox makes it easy to schedule and record your management review meetings G uron Kindest Regards, Yusuf Khan c Engg ™ Tech (Hiawe) Dy General Manager ~Quality L&T Infrastructure Development Projects Limited, 9 Avenue, 2° Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, ‘Ahmedabad -380059 (Gujarat —India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: Yusufkhan V Kukad Sent: 06 March 2014 13:16 To: Shreebanta Kumar Das Subject: Meeting Tactics Meeting Tactics Bad meetings are a waste of time, and for those involved in complex tasks like writing, designing or programming, the time spent in the meeting is only part of the problem ~ the interruption of thought processes is a bigger issue. Here are some tactics for running effective meetings, and a few tips on avoiding the bad ones. DON’T Do you teally, really, have to have a meeting? For one-way information delivery, there ate more efficient ‘ways to get the information out — send an email instead, Use mectings where you need a discussion and input from the participants, or you anticipate lots of questions and discussion from attendees after the (short) information session. If you must, then: PLAN - Set objectives/outeomes: “By the end of the meeting, I want the group to..." + “have come to a decision on, + “have made a plan of action for “have learned about our new initiative” — (please read #1 again) Make sure that you communicate the objective to all the participants, and if you are an attendee ~ ask for the objective before you commit your time. Insome cases you may need to provide the context along with the goal, happening, and we need to make a plan of action for . ‘our major expansion into ... is - Prepare:For the meeting organiser(s) this means an Agenda. ‘Think about what you want to say and what you need to Jearn in order to reach the goal you set in #2. Make sure you send the agenda to the meeting participants before the meeting ~ at least 24 hours before. Allow more time if they will be presenting data, For the attendees, this means there is something to read or something to do before the mee! ng Reviewing contracts/documents? Don't read them in the meeting! Circulate them beforehand for reading and have everyone bring their questions/suggestions to the meeting. + Need to analyse performance? Charts and data should be prepared, along with some conclusions drawn from the data. After working out the agenda, you will have a better idea of how much time to allow for the meeting, Break it up if it’s too long and consider whether you can invite attendees for particular agenda items and then let them go. If so, you'll need to allot a time for each agenda item. DO Confirm the meeting the day before, Send out a reminder of the time, place, and the required preparation, - Start on time. ‘You need (o respect the people who do turn up on time, not those who don’t, Some suggest closing the door and having latecomer’s pay a fine into the coffee jar: If the organiser is late, the participants have some options too: + start without the organiser ~ either on this meeting’s agenda, or pick another topic you need to discuss, + depending on the distance you need to travel, you could go back to work and ask someone to call you when the meeting is actually starting, + after-45-20 minutes, everyone should leave. Arriving this late to your own meeting is really bad form. By this time, the organiser should have called to say when they will be there, or to reschedule. + Stay on target. You went to the trouble of setting an agenda, and now you need to stick to it. Having someone act as the timekeeper will help. Anything off-topic that’s not helping to reach the meeting objective should be “parked!” for a later discussion, or assigned as a task for exploration. If there’s something that can be resolved by a much smaller group, assign it to them as a task. For each agenda item, as soon as you have the information, requested permission, decision, or tasks have been assigned, it’s time to move on, If the mecting organiser won't do it ~ step up as a participant and show how it’s done ~t being wasted. your time Don’t allow phones, laptops, ete to be used in the meeting, You really can’t give your attention to two things at once. If it can't wait, it gocs outside. = Record it, ‘You must keep minutes/notes. This is best done by someone else ~ preferably someone who does not need to be a major participant in the discussions, Record who attended, who was missing, and the outcome of each agenda item. Collect any information/data documents to attach, record decisions made and tasks 2assigned as they happen. You do not need to record who said what, unless it’s a formal motion that’s proposed and seconded. For important decisions, you may want to briefly record how the decision was reached, .g., what was considered, rejected ete, At the close of the meeting, summarise what's happened ~ major decisions, follow-ups and next actions, - Finish on time, ‘You must respect the time of your attendees. If you're an attendee and not getting that respect, consider leaving after the time you agreed to commit has passed. Send the minutes to all the attendees within 24 hours, CHECK Assess and improve your meeting process. You can self-assess or ask for comments at the end of the meeting, Did you achieve your meeting objectives)? What worked, what didn’t? What could have been done better? Calculate and publish the cost of your meeting to the business. Include the time costs for all participants. ‘Was it worth it? ACT (hello Mr Deming, ..) Incorporate improvements into your next meeting. Kindest Regards, Yusuf Khan c engg m Tech (Hswry Dy General Manager -Quality L&T Infrastructure Development Projects Limited, 9" Avenue, 2 Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat —India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: Yusufkhan V Kukad Sent: 06 March 2014 14:31 To: Shreebanta Kumar Das Subject: Planning for Quality - System Planning for Quality - System In addition to planning the delivery of your product or service, you will also need to plan for the requirements of the quality management system itself, This kind of planning for quality is very much like developing a business plan and does not need to be a seperate process. It begins with setting the overarching “mission statement” which, in the context of ISO 9001, is the quality policy. Typically these are high level statements like “We commit to meeting our customer expectations”, “We will strive to be the leading provider of XYZ, widgets in Australia”, ete. and are usually over a longer time frame of the order of 5-10 years. There are many business analysis techniques to help this future gazing. ‘The quality plan translates the aspirational mission statements into an action plan: ‘ation Task Setting Objectives ‘The next level down is setting objectives that are consistent with the goals stated in the policy, but over a shorter time frame — usually 1-2 years. You want to know when these objectives have been achieved, so they need to be concrete, measurable goals, You also want to have a fair chance of success, so make sure the goals are for things that you have control over and are realistic. Quality objectives will also address areas of concern that have arisen out of business analysis and review processes. For example, let's say the quality policy states (as many do): “We commit to meeting our customer expectations”. Here are some objectives consistent with this policy, along with metrics and targets:Objective Target Current Reduce product joss than 5% complaints and returns 1% ‘eon-time 75% of delivery dates should be as scheduled or 68% on time, 15% eee earlier, with a further 10% no more than days deliveries more than 1 2 late. week late, Action Plan Once you've decided what the objectives are, you'll need to formulate a strategy or action plan for achieving them. What exactly you will do, what will be measured, what constitutes success, who is responsible and what will be needed to make it happen, (Pretty much the same as for a project quality plan: Fequirements, acceptance criteria, methods and resources.) This will require a good understanding of the current situation, problems that need to be addressed, and opportunities for improvement, Top management will need to be involved to allocate & approve appropriate resources. For measurements, try to use mettics that normalise the measurement against other factors to keep it in context. ¢.g., if sales double, the raw number of customer complaints may go up —a seeming failure, but if the metric of complaints per unit sales decreases then the true story is sticcess, Here are some example actions to be taken in order to achieve the objective to “/mprove on-time delivery rates” What we will do What will be measured Who When Improve forecasting by } , a PRICE Rea Predicted vs, actual time from Production gem er eee customer order to product, Manager & 1-7. Verify lead time data from ‘Time between order and : : suppliers fulfilment Stores February Introduce KanBan system to Numbét of ye oe aE Production Novener smooth out order demands ele ye die ta ut cnstg Manager letemnls components. Review and Revise Finally, do what you planned to do and review the objectives to see if it worked. Then update the plan. G@ var Kindest Regards, Yusuf Khan c cngg M Tech (Hawa) Dy General Manager ~Quality L & T Infrastructure Development Projects Limited, 9" Avenue, 2* Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat ~India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad Yusutkhan V Kukad 06 March 2014 13:28 Shreebanta Kumar Das Business Planning techniques Business Planning techniques Most businesses need to plan ahead to be ready for changes. Some planning is for changes initiated by internal drivers ~ e.g. introducing new services or products. Others are driven by factors external to the company e.g., changes to regulations, changes to standards, changes in customer expectations. As far as possible, itis better to be pro-active rather than reactive, ‘There are a multitude of analysis tools to assist in business planning that can be useful in a quality ‘management system, ¢.g., SWOT analysis (strength, weakness, opportunity, threats), PEST analysis (political, economic, social, technological), Balanced Scorecard (financial, customers, processes, learning & development) to name a few, Here’s some resources online to learn more: SWOT: + http://wvww,business.qld.gov.au/business/starti analysis + http://en.wikipedia.org/wiki/SWOT. analysis SWOT ANALYSIS Helptul Harmfut © bitp://www.bu palls.com/pestanalysisfreetemp! + hitp://en.wikipedia,org/wiki/PEST analysis Balanced Scorecard: « http://www.businessballs.com/balanced_scorecard.htm + bttp:/Awww.quiekmba.com/accounting/mgmt/balanced-scorecard/ + http://en.wikipedia.org/wiki/Balanced scorecard 1Yusufkhan V Kukad Yusufkhan V Kukad 06 March 2014 14:36 Shreebanta Kumar Das Planning for Quality - Product / Service Planning for Quality - Product / Service In the case of quality planning for product requirements, this refers to the detailed planning that goes into assuring that the product or service you provide meets legal and customer requirements, This includes: « first understanding the requirements (what does the customer want, what laws apply), + making sure you have the necessary resources (people, equipment, time, finances), «delivering the product or service, and + verification procedures. For highly variable and complex work like construetion projects you would prepare a quality plan for each job that sets out the requirements, acceptance criteria, the methods that will be used to ensure that expectations are met, and the resources needed. Example project quality plans can be found online: hitp://eastcoastdesignerbuilders.com.au/pat/ POPC Draft . {ftp://ftp.dot.state.tx.us/pub/txdot-info/tta/shiz1_eda/const ual “plan.paf //www.epa.gov/region5/cleanup/sheboygan/pdls/sh ‘/www.gunnspulpmill.com.au/iis/V16/V16_Asa.pdf Where processes are fairly stable, planning for quality covers the same content, but is performed for each process not for each job. The “quality plan’ is incorporated into your realisation processes and is likely to be documented in SOPs (standard operating procedures) and work instructions. (Here’s an HACCP based example SOP for food recall (pdf download), Lego make great work instructions , and here's an example (pdt download) that combines the high level SOP content and the more detailed work instruction content in the same document) https neither case, process records demonstrate you have implemented your planning for quality. (¢.g., forms to fill in, checklists to follow, measurements to be recorded or monitored, hold points, reviews by senior personnel) These records provide data for decisions on whether to change the process, and are also used in auditing, ment system itselt Planning for quality also happens for the quality man: G taricm Kindest Regards, Yusuf Khan c éngg M Tech (H&WR) Dy General Manager -QualityYusufkhan V Kukad —————— From: Yusufkhan V Kukad Sent 06 March 2014 14:43 To: Shreebanta Kumar Das Subject: Calibration Calibration What is Calibration? Calibration is the process where you confirm that your measurements are true. This is usually done by ‘measuring a standard and ensuring that the error is less than the requirement amount. ‘Take calibration of a scale for example, A standard weight is known to be 5.000g. Your measurement is 5.05g This means your error is 0.05g. Depending on the accuracy required, this may mean pass or fail. A required tolerance of +/- 0.02g means the scale has failed calibration. A tolerance of +/- 0.10g means the scale has passed. The tolerance of measuring equipment is set by the manufacturer, but is also determined by your process requirements. A real calibration will test the measuring equipment over a range of measurements ~ either the full range of the instrument or the range over which it will be used Re-calibrate. Equipment degrades over time and must be re-calibrated periodically. Imagine that you have a simple vo/io-2o gauge to determine the conformance of an item. Over time the gauge will weat, and will perhaps show more components as “good”. It might appear that production is improving, when in fact, the gauge is simply out of calibration. (The revérse is also possible, depending on the gauge.) image details ') How often? ‘The interval between re-calibration is deter nined by a number of factors: * manufacturer recommendations+ operating environment * accuracy requirements + how long the instrument historically stays ‘true’ What needs calibration? Not all companies need to calibrate and for those that do, not everything will require calibration, Obviously, if you don’t use measurement and test equipment (e.g. a labour hire company) then you won't need to calibrate, These companies can claim an exception to this part of the standard if they are seeking certification to ISO 9001. ‘To determine which equipment must be calibrated, there are a number of things to consider + Isit required by the customer? e.g. In Australia, the Civil Aviation Safety Authority (CASA) requires calibration of all equipment used to determine whether a component satisfies requirements for return to service. + Isit required by the product specifications? e.g., If measurements must be within tolerances, then you will need to calibrate your equipment to be sure that your measurements are true, + What are the consequences of the measurements being wrong? e.g,, accepting bad components, processing returns, rework, rejecting good components, increasing the difficulty of further processes, unhappy customers, ete. These costs can far exceed the costs of calibration. + What is the cost of calibration and repair compared to the cost of replacing the item? (Note that you will still need to control this equipment and have a way to determine when it is no longer serviceable.) Where calibration is not required, it is usually good practice to mark the equipment.as such. Keeping records When you do calibrate, it is important to check the certificate for the results. The receipt of a certificate does not necessarily mean the equipment is good. Some certificates clearly state a pass or fail result. However, others rely on you to decide the result, which depends on the accuracy you actually need, Our lead consultant, lan Clark, recommends that cach certificate be signed to verify that it has been checked prior to storage of the certificate. In some cases the storage method consists of shoving the certificate into a filing cabinet, never to be looked at again, However, having the calibration history more accessible can be valuable, This information helps you select the optimum calibration frequency, detect ongoing problems, and will reveal when equipment is reaching the end of its lifetime, This can be recorded on a paper ‘log’, spreadsheet or database. In QSToolbox, measurement and test equipment is stored under the Asses section. Calibrations ean be scheduled at the required frequency and appear on a central calendar. When maintenance or calibration work is performed, a record is added to the asset. Certificates and other documentation of the work can be uploaded and stored with the record. The history of the instrument is then easily accessible, and individual certificates can easily be retrieved. Here’s more on managing calibration usit SToolbox.What happens when it fails? ‘When your equipment fails calibration it is a non-contor All the measurements since the last calibration are now suspect. The effects will depend on how critical the measurement is, how badly out of tolerance the equipment is, and how long since the last calibration, It may require corrective action such as re-measurement, rework, product recall. In QSToolbox, this would be documented in the is corrective actions recorded as respon: c trucker as a non-conformance issue, and the " The image above is from a short video (~12mins) made many years ago’by thie US Navy Calibrate?” The video covers why it is important to measure output (cannonballs, in this case), why you need to calibrate your measuring equipment, and some of the consequences of failing to do so. It also explains how calibrations are traceable back to a reference standard Kindest Regards, Yusuf Khan c Engg M Tech (Hawe) Dy General Manager ~Quality L & T Infrastructure Development Projects L 9" Avenue, 2" Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070 ited,Yusufkhan V Kukad Yusutkhan V Kukad 06 March 2014 15:06 Shreebanta Kumar Das Intemal Audits (Check or wear tae = I e Review Responsibilities 2” (D racking 9° Quotations 7B 0" 8 bg ee ae Be Og gi? BBose a O. 888 Bao 5 te oe s38F SB" 8 MX Ep) Monitoring 4 = S_Nonconformance 25 An audit is simply another form of inspection and testing — except that in this case the product being inspected is the management system itself. Like a product inspection, an audit simply compares how things actually are, to how we think they are and how they ought to be. Audits help uncover areas that are in need of attention and they ean be an opportunity to draw back from the day-to-day details and to take look at the whole process with fresh eyes. Despite being such a (potentially) positive tool in the management system toolkit, audits often induce the same kind of stress as end of year exams! Obviously a great deal rides on a successful external audit so some anxiety is expected. However, a good Internal Audit process can reduce the stress, site you can uncover the problems yourself and resolve them. before the external auditor begins. ‘We suggest you enzol in a professional development course before jumping into the tole of Auditor. An alternative is to use an external consultant to perform your internal audits for you. Quality, safety and environmental management standards all require audits to monitor and report on the effectiveness of the management system. This process is also one of the six «locumented! procedures required by ISO 9001:2008, A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. ‘You are also required to keep records.What does an internal audit process look like? saa Internal Aveits | emrrecer of Each company will have their own particular method, but it will generally follow the same process. Plan your Audit Programme Internal Audits need to be scheduled at planned intervals to check that the quality system conforms to requirements and that the system is effective. ‘Requirements’ include the standard itself, as well as the ‘company’s own requirements (i.c., it's own procedures and policies), ‘You don’t need to audit every process all at one time. The External Audit may be like this, but internal audits can be spread out with different processes audited at different times ~ a series of ‘mini-audits’. The standard does not set out a required audit frequency. Instead, it recommends that you consider how important the processes are, their risks, their prior history of problems, and also your quality objectives. With a series of ‘mini-audits’ you can set different audit frequencies for different processes. If you are implementing a new management system, we recommend that you should have audited all the processes identified in your management system at least once prior to the initial Certification Audit. Work out who will audit. An auditor should be objective and impartial. You cannot audit processes that you manage / control yourself, This means you will need to have at least two internal auditors trained and available. However, due (o lack of resources, or sometimes with the crossover of responsibilities that is common in small businesses, having two impartial auditors may not be possible. In this case, you may need to consi an external resource. Large organisations may use a team of auditors, Define the requirements for each audit. ‘The plan already identifies the area you will audit, now you need to define what criteria you will audit against. Sometimes this takes the form of a formal checklist with a pre-determined list of questions, You can also use a copy of the procedure being audited and mark this up with questions and points to verify. You'll need to identify what records should be checked to verify the process. Any previous findings or issues related to the audit area should also be checked. Even with pre-defined questions, an auditor will still need to ‘follow their nose’ if something is not quite right.‘You can define the criteria for the audit prior to cach audit rather than having to set this up at the planning stage. ‘These requirements (checklists, documents, records, etc) should be communicated to the auditee some time prior to the actual audit taking place. (Specify the time in your audit procedure ~ a week is reasonable) Conduct the audit An audit usually starts with an opening meeting where the auditor meets the auditee(s), sets the expected timetable and out how the audit will be conducted. During the audit, the auditor will work systematically through the checklist or procedure, examining evidence that the process meets the criteria. It’s common to markup the checklist with notes and a quick finding result, e.g., C=compliant, NI~ needs improvement, NC ~non-conformance, "723 Custemor Communication [The company has determined end implemented eflecive airangemonts for communicating wih customers | in ion to C__|Very wet done, specs, progress reports ee: Engquvies, coniracte or order handling, including amendments, Ni [See above + variations managed - process not Jcontretied adequately [Customer fesdback, incioding customar [complaints No _ |2formal customer complaint handing systom In piace. When recording the audit, it is important to write down exactly what evidence was examined to establish the finding ~ regardless of the finding. e.g. auditing jee training records the auditor writes: (Note that the date is an important part of the evidence), Usually the auditor will discuss the finding with the auditee before recording it. This is to ensure the finding is understood and to confirm there is actually a problem, e.g. the auditee above may reveal that Joe Bloggs’ personnel folder includes a separate safety briefing record with the required signature. This can sometimes negate the finding, or just change it — i.e. the signature is there, but itis not following the procedure. In this example, the consequences of not following the procedure are minor and the audit finding should reflect that. ‘The audit will finish with a closing meeting where the lead auditor gives an overall summary of the audit and discusses cach audit finding to ensure they are understood, Document the Audit findings An external certification auditor will submit a formal written report on the audit to management several days later and it’s common for an internal auditor to do the same. However, there's no requirement in the 3standard for a formal audit report. You simply need to ensure the findings are recorded and communicated to management. You could just record the findings and their details in your non-conformance form & register (or as an ‘Issue’ in QSToolbox). ‘You will need to retain records of the audit which will typically include: Completed Audit Checklists and/or marked up procedures Notes on objective evidence examined, and personnel interviewed Audit Findings (cross referenced to your Nonconformance Register) Audit Report Take Action on those findings! Findings raised at both Internal and External Audits need to be addressed with corrective actions, If the audit reveals that we don't do as we say, then we either change what we do, or change what we say... At the next audit, the auditor will verify that the corrective actions taken were effective in bringing the ‘management system into compliance. More info... Have a look at the auditing process using QS Toolbox, The ISO Standard ISO 19011 has guidance on auditing, It sets out requirements on training and experience for auditors, and requirements for how audits should planned, conducted and recorded. Kindest Regards, Yusuf Khan c engg m Tech (Haw) Dy General Manager —Quality L & T Infrastructure Development Projects Limited, 9” Avenue, 2°4 Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdey, ‘Ahmedabad -380059 (Gujarat —India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: Yusufhan V Kukad. Sent: 06 March 2014 15:10 To: Shreebanta Kumar Das Subject: Process Improvement - 5S Process Improvement - 5S It is nowhere near as catchy, but essentially the 5S technique is to clean and organise your workspace to mprove your workflow, and then to make this “the way it is done”. Sort ‘The first task is to sort everything in the work area so that unnecessary items (tools, parts, equipment, storage bins, etc) can be removed and either discarded or stored elsewhere, ‘This step de-chutters the ‘workspace and prioritises tools and materials that are used frequently, Straighten (Set in order or Systemise) ‘Then you arrange everything in the work area so that the work flows in an orderly fashion. This often involves creating storage solutions that facilitate the work flow, by placing more frequently used items so they are quick and easy to access. This step is usually about a workstation but can also include rearranging process steps to improve work flow on a larger scale. Shine (or Sweep) Depending on the starting state, this may involve a big initial effort, and can include painting and installing better lighting to make the workspace clean and tidy. Apart from resulting in a more pleasant and safer work environment, it will also be much easier to notice leaks, spills, breakages, etc, However, ‘shine’ is also an important part of the ongoing process where the work space and equipment ate cleaned and restored to their proper place at the end of each shift. Basic preventative maintenance tasks like tightening, oiling, restocking are patt of this. The workstation is then ready for the next user (or the next day) and the order created in the first two steps is preserved. Standardize So that the 5S project is not just a spring cleaning exercise, you will need to ensure that everyone knows what are the current steps to follow and to establish expectations for the process. In order for the changes to ‘stick’, you will need to conduct training, create documented procedures, work instructions, use visual guides, checklists, and/or photos. It will be easier to make changes if users of the 1system understand why they were made and ideally, they will have been involved in making the changes in the first place. Visual controls include the familiar tape markings and shadow boards. By assigning everything to specific locations, you reduce time wasted looking for tools or equipment. If good visual controls have been installed, it should be immediately obvious if a problem exists in the work area, e.g, a missing tool. Where there are multiple workstations for the same or similar tasks, setting them up in a standard way will increase efficiency and make them much more interchangeable for users. Sustain You have to keep it going so that the old ways do not return, otherwise all that time and effort and $$ will have been wasted. You will need to followup over a period of time until the ‘new way’ becomes entrenched. ‘This will be easier if the changes have made it easy to do the right thing. The design of the work should facilitate the process, not place a burden on employees. Sustaining the new processes is often the most difficult task, If the focus drifts away from SS, then the work area will drift back to the old state. Strategies include daily meetings, ‘mini-audits’, and ongoing continuous improvement efforts. © taro Kindest Regards, Yusuf Khan c engg ™ Tech (H@wR) Dy General Manager ~Quality L & T Infrastructure Development Projects Limited, 9” Avenue, 2" Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdey, ‘Ahmedabad -380059 (Gujarat —India) Mo, +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad Yusufkhan V Kukad 06 March 2014 15:12 Shreebanta Kumar Das Zero to 9001 - the pathway to ISO 9001 Zero to 9001 - the pathway to ISO 9001 Where are you now? Are you thinking about starting your journey to ISO 9001? Maybe you are already getting prepared, well under way, or perhaps you got a litte lost on the way. Here's a brief guide to what you may find on your path to ISO 9001 accreditation, If you don’t find what you need, please contact us and we'll be happy to help. ing about ISO 9001 me more info on I$ 9004 ~ costs, time, resources tarted with your ISO 9001 Quality Managing people, com Manag omer Require Plan Logisties Hge Sy ag sere . Call in the External Auditor Kindest Regards, Yusuf Khan c éngg m tech (awe) Dy General Manager Quality L & T Infrastructure Development Projects Limited, 9 Avenue, 2° Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, Ahmedabad -380059 (Gujarat India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: Yusufkhan V Kukad Sent 06 March 2014 15:13, To: Shreebanta Kumar Das Subject: 1. Just thinking about ISO 9001 1. Just thinking about ISO 9001 We are new to this ~ why do we need ISO 9001? ‘The very first step on the path is to determine why you need ISO 9001. Here are some reasons why other businesses have decided to pursue ISO 9001 certification: * Our major customers want us to be certified, because our product affects the quality of their product. Being ISO 9001 certified is a pre-condition of a large government tender. We want to be ready for growth and have our key business processes documented. We need a quality system to capture defects and take corrective action. We aim to sell this business soon and think being accredited to ISO 9001 will add “value” to the business. + Itwill be easier to train new employees if we have our core processes documented. © wsrion Kindest Regards, Yusuf Khan c engg ™ Tech (Hawr) Dy General Manager Quality L&T Infrastructure Development Projects Limited, 9" Avenue, 2° Floor, Behind Rajpath Club, Sarkhe}-Gandhinagar Highway , Bodakdev, Ahmedabad ~380059 (Gujarat —India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070Yusufkhan V Kukad From: Yusutkhan V Kukad Sent: 06 March 2014 15:15 To: Shreebanta Kumar Das Subject: 2.1 need some more info on ISO 9001 - costs, time, resources, 2. [need some more info on ISO 9001 - costs, time, resources. How much will ISO 9001 certification cost? Costs can vary greatly depending on how much input you ean provide to develop the quality system documentation Costs may include: * Cost of external consultant to develop documentation and provide support during implementation * Cost of internal resources to develop documentation, conduct internal audits & system review meetings * Cost of Certification (External Audit Fees) + Ongoing system maintenance costs External Audit Fees are based on a three year compliance cycle. ie. the cost to maintain certification for a tree year period. This fee includes: + apre-certification audit + the actual certification audit, and + anumber of surveillance audits, ‘You will need to be re-certified after three years and new audit fees paid. The price charged by most certification companies is based on the number of employees in your company, There is a sliding fee scale set by each national certifying body. Certification fees can range upwards from a low of around $4000 for the three year compliance eycle. How long will ISO 9001 take? Small businesses can generally manage to achieve accreditation in about 10 to 16 weeks. Larger organisations may need up to 9 months, or more, The time taken to achieve certification can vary from ‘organisation to organisation and depends on: « How much time it takes to prepare system procedures, forins, checklists + How much training can be provided to develop an awareness of the system requirements across the organisation * How quickly you can generate sufficient systems records to provide the evidence that your quality system is working effectively How quickly you can resolve internal audit findings Availability of auditors from your chosen Certification BodyDo I need external help to get ISO 9001 accredited, or can I do it myself? If you do not have sufficient internal resources to develop your own quality system documentation then you may need (o hire an external consultant / mentor to assist. This will certainly add cost but may well be the only way to drive change internally and get the job done. Remember, well qualified / experienced consultants understand the ISO 9001 standard thoroughly and are capable of pointing out the “must-do” requirements — in many cases they can save you writing non-essential documentation, Consultants may choose to work on an hourly rate or a single project fee. Consultants should provide a warranty in regard to non-conformances detected at the Certification Audit confirming that they will offer their services free of charge to rectify problems attributable to deficiencies in documentation that they generated Kindest Regards, Yusuf Khan c Engg m Tech (Haw) Dy General Manager -Quality L&T Infrastructure Development Projects Limited, 9" Avenue, 2" Floor, Behind Rajpath Club, Sarkhej-Gandhinagar Highway , Bodakdev, ‘Ahmedabad -380059 (Gujarat —India) Mo. +919825028219; Office 0796667000/7021, (Fax) 079 66067070