Quality control is one

Quality control is one of the

TABLE OF CONTENTS 1. Executive Summary 2 2. Introduction 3 2.1 Data type collected 4 3. Process monitoring and control 6 3.1 Process Improvement 10 4. Tools 12 5. Evaluation of results 17 6. Recommendation 20 6.1 Implementation plan 22 7. References 25 1. Executive Summary Quality control is one of the most vital and fundamental activities for every organisation, regardless of their size, nature or the sort of competitive environment they are thriving within. The paper to follow would incorporate a discussion and evaluation of different techniques and best practices for enhancing the key process monitoring and measuring activities. Ensuring quality is something that starts from procurement of raw materials, thus starts from the very beginning of an entire production chain of activities. However this paper concentrates upon an organisations direct manufacturing monitoring and measuring activities for CNC machining of components. delivering to diverse industries. It is vital for any organisation to assure quality regardless of their precise genre of products they produce. This paper discusses the current practice for monitoring and measuring activities within the organisation with the techniques used for data collection. Enhancing inspection processes would start from examining the current process from which data would be gathered and analysed against clients expectations, followed by making changes to the current process according to the changing needs of the clients. The current tools used within monitoring, measuring and improvement activities are also discussed. The paper then analysis all the activities against current best practice within the industry which has four main pillars. It would end off with a conclusion alongside recommendations for PDQ Engineering Ltd. to embark upon to enhance its processes. Two recommendations are discussed one for preventive control and another for in-process control. 2. Introduction The organisation that is being considered for this paper is highly regarded for providing state of the art CNC precision manufacturing components to a worldwide a client base. The organisation is PDQ Engineering Ltd which has two manufacturing units of around 11,500 & 2000 sqft located in Washington, Tyne & Wear. The organisation is ISO 9001:2015 certified and has won various customer awards over the years for offering a range of the finest quality precision components to diverse industries. The organisation does have a wide range of multi axis live tooling CNC computer numerical controlled machine tools. The organization does enjoy a competitive position for being capable of producing precision components in a variety of sizes to fine geometric tolerances. CNC machines are computer-controlled equipment generally used for the production of complicated, tight tolerance machined parts. CNC is normally used for low to medium volume production due to the programming time required. The advantages of these machines is that once programmed they will produce the same component on a highly repeatable basis (Mary-Clare Bushell 2011:155) Modern CNC machines can complete both turning and milling operations. Multi headed turrets can hold multiple tool posts which can hold every tool necessary for the production of the component without removal of any tools merely by indexing the turret to select appropriate tool. In more advanced machines two chucks and turrets will be utilised within the machining centre to complete one operation in one chuck then finish the component complete in the second. Aided by an automatic bar feeder and fed from one chuck to another the machine can run automatically thus whilst maintaining a degree of accuracy the speed of production is dramatically increased while lower costs making the organisation highly competitive with this technology. Certainly, this more advanced machinery fits the criteria for a particular client who manufactures safety critical equipment for fire brigades with PDQ being able to compete highly on price, quality whilst delivering on time every time for high volume batches. Our other typical clients are form oil & gas, medical, filtration and general engineering fields. 2.1 Data type collected There is one fundamental type of data or information that is used by PDQ Engineering and this is classed as quantitative data. Quantitative data is data expressing a certain quantity, amount or range. Usually, there are measurement units associated with the data, e.g. millimetres, in the case of the thickness of a part. It makes sense to set boundary limits to such data as in specific tolerances, and it is also meaningful to apply arithmetic operations to the data with the data being amenable to statistical manipulation, e.g. histograms etc. There are two types of quantitative data, which are referred to as discrete and continuous data. Basically, counts are discrete and measurements are classed as continuous. Discrete data is a count that cant be made more precise e.g. count of good or bad. Characteristics with the aid of metrology equipment that can be measured precisely in PDQs case is classed as quantitative continuous data. This form of information is convenient as this gives actual measured dimensional, satisfying customers product traceability requirements. The following tables are examples of data collected, acceptance criteria to be validated against and also manipulated data for statistical purposes; The table above shows information gathered during a General First Off Inspection. When all the dimensions are accepted Acc then the manufacturing process can continue. If any are rejected Rej then the manufacturing process would not go on until the quality is checked thoroughly and matches with the quality standard/tolerance as below; The table below again represents quantative data gathered during conducting a customer requested process stability study on specified characteristics for safety critical equipment. There are clearly other types of data that could be collected by other organisations, apparent through methods such as tally checks, check lists(process/product audits), automatic test equipment(ie.functionality tests), databases etc. 3. Process monitoring and control The key to produce the right quality of products is inspection and monitoring throughout the production process. It is vital for every manufacturing operation to prioritise quality above any commercial objective otherwise customer satisfaction cannot be attained. The process of monitoring and control involves a series of steps that are focused on the single objective to ensure quality of the finished product. The customer which is being considered in this case is a UK based company in Blyth which manufactures Breathing Apparatus which serves a worldwide customer base of Fire Brigade authorities. In order to assemble and fully test, the breathing apparatus must undergo extensive qualification & testing due to the safety critical nature of the industry prior to release to market. A number of sub assembly components are subcontracted to PDQ Engineering, which is seen as an extension to their own Cnc workshop. Therefore, monitoring the manufacturing process of the precision components automatically becomes of great importance to be able to match our customers own extremely high standards. The manufacturing process below idealizes the manufacturing of the precision components that is further described underneath the diagram; The monitoring process starts with a Route Card which besides the technical drawing issued by the customer is the main production realization document. This is issued to the supervisor, who would be accountable for the entire production process. Route refers to the idealized(preferred) process for producing the precision components to be further used in forming the Breathing Apparatus. The supervisor when allocated with a new job, plans and allocates different tasks to different machines, on the other hand for repeat work the preferred routing is already saved on the ERP system. Then there is further help for the supervisor which is in the form of the operator/setter, who will be accountable for checking and recording measured first off dimensions on the route card. Moving further, once the operator is ready for batch production and is sure that all the dimensions are correct and meet the customers acceptance criteria, it is passed to the quality control department for primary or First Off Inspection. Upon successful completion of the first off inspection the machine is allowed to run the remainder of the batch with the aid of in-process operator pre-determined frequency checks which are on the route card through the ERP system again. When the first operation is complete, the machine operator would move onto the following operation; in case there isnt any other operation the batch would be sent for final inspection process and processed further. In case of a further operation, the previous process would be repeated all over again; operator would check and record the dim as on the route card and would pass on for Quality check prior to final inspection. Upon completion of the required component production, the batch would be classed as conforming or non-conforming product. Conforming product will be passed to despatch while non-conforming product will be rejected and quarantined. Gathering information during the process is vital for feedback on the product, this would be gathered during the monitoring process. The controlling and monitoring process would help the supervisor to come across the points that are new, as in deviations in the process. This will allow the supervisor to notice the changes that are needed to bring the process back under control. The customer requirement criteria would be evaluated against the produced goods in order for checking the acceptance ratio, ie).IPPM, RFT. PDQ also receives regular reports from client procurement, SQA departments on Quality on OTDP measures. These can be taken opportunities for improvement or processed as a potential risk factor. Customer satisfaction surveys are also employed by PDQ as a way of acquiring a broader conception regarding the finished product listening to the voice of the customer. Customer perception data holds significant value for the purpose of matching clients views whether from an evidence approach or not with the required quality supplied. Therefore, clients are contacted twice a year in order to evaluate opportunities for improvements and assessing risks where appropriate. The aim is to be proactive rather than reactive. The survey is be measured quantitively with responses from 1(poor) to 5(very good) below is a quick sample of questions which could be asked relating to quality; How do you rate our ability to respond to your technical queries ? How do you rate our product quality ? How do you rate our response to your complaints ? How satisfied are you with our corrective actions taken against complaints ? How do we compare to our competitors ? Overall how satisfied are you ? 3.1 Process improvement There is a part in the manufacturing and controlling process that is about rejection of non-conforming parts. This on one hand can be frustrating for manufacturers, but on the other hand carries vital information along when comparing process performance to customer requirements. Rejection of the finished product means the product isnt compatible when comparing process performance to the expectation standards and requirements of the customer. These requirements are generally in the form of component technical drawings for sub-contract manufacture and the standard tolerances are to ISO2768-f. Therefore, there are changes that must be made in order to enhance the finished product. It is necessary to consider customer requirements at every stage of the production process if possible to match with requirements of the finished components. The rejection should be viewed as an opportunity for improvement and a way of mitigating any risks within the manufacturing process. Identifying the issues during first-off inspection can lead to stopping the production process and unwanted downtime when temporary correction takes place before formally embarking on root cause analysis. Upon non-conformance from the client after final inspection, ime for a team with involved in the process to evaluate machine setting, programming and tooling arrangements. Once checked and identified the issue, supervisor would advise the machine operator to make necessary modification for matching with the customer requirements for future batches. The supervisor is accountable for the allocating the operations to be carried on the machine, as is the route card preferred sequence then conveying to the operator to check and record the dim on the route card (a vital information) that has to be considered for any modification or change to the process in the machine. The operator then passes to quality check for first off inspection, the inspection is about the measurements that have been followed for producing products of a certain quality The inspections have to be done in consideration to the client requirements, therefore it is vital to record every modification to the machine operation via FRACAS (failure recording and corrective action system) and how the product is being produced. Upon final completion of the production batches, the final inspection begins, whereby the customer has to be present for validation of the components produced for their own internal processes. The main point is it is vital to consider the information provided by the customer at every stage of production in avoiding rejection after final completion. Extracted data during the rejection of components carry vital information as mentioned earlier; because it helps the manufacturer to make necessary changes in achieving conformity. The information gathered during the rejection would be constructive for making positive changes . If from a client perspective there is a change in breathing apparatus design that would be discussed and processed within order amendments. As far as the improvement is concerned, risks and opportunities would be addressed through such standards as in ISO 9001:2015 and opportunities for improvement through regular process audits. It must be clearly noted that without data collection their can be no continuous improvement. The main internal method used to assess the impact of improvement actions on process performance is PDCA or the Plan, Do, Check and Act cycle that has to be considered precisely after first of failures and production stoppages imparticular. PDCA is a four step management tool used in business for the control and continual improvement of processes. It is more commonly known as the deming wheel or the shewart cycle. The supervisor & quality department would Plan the recommended changes for production necessary to deliver results in accordance with customer requirements; Do this is implement the process which could be fed it into the machine, Check Monitor & measure requirements of the process and report results Act take actions to continually improve process performance. The cycle is clearly circular and at the end actions are either taken to keep the gains made or the cycle is started again, just as circle their is no end until continuous improvement is achieved. 4. Tools There are certain category of tools that are to be used precisely for gathering information and evaluating them. The tools that have been used are- process capability studies on new parts supplied to Draeger Safety Uk and 8D root cause analysis methodology. Process Capability Studies on CTQ: In general sense, process capability helps in achieving uniformity in the process. In the process, variability of CTQ features is considered as a measure for knowing the uniformity of the outputs. This is a widely adopted approach as it manages to quantifiably predict the capability of any process. Variability can be judged on a CTQ over a period of time covering a batch of product. It should be noted that process capability studies help in measuring CTQs on the product on continuous basis however at present the goal is to approve the process on new parts to PDQ. Process capability helps in drawing comparison between the specifications that are evaluated as per the requirements of the customers and inherent variability(deviation) in the process. The CTQ features in Draeger products are described as QF(critical to function) & QS( critical to safety). The processes used to manufacture Draeger products always have variables which can be used to adjust the process but sometimes it can be a mixture of tooling, programming and materials. Before allocating a job to a given machine or process, it is necessary to establish whether the process is capable of meeting the specification. A simple approach is described below: a) Set the process to meet its target figure. This would normally be the mid point of specification b) Ensure the process is stable and under control c) Take 50 consecutive units from the process and measure them accurately to one more decimal place than the specified tolerance, e.g. if the specified tolerance is +/-0.01mm, then measure to the nearest .001mm d) Assuming that the distribution of results forms a smooth bell shaped curve, calculate the arithmetical mean and standard deviation of the 50 units e) The process capability (Cp) is considered to be six standard deviations. Now compare the six deviations with the specified tolerance thus: Cp = Specified tolerance / 6 standard deviations The potential process capability is the best that the process can achieve having eliminated special cause variations. The process is said to be stable when the variations are due to random causes only. Six standard deviations are considered to contain 99.7% of all items made. To determine if a process is capable the statistic Cp is calculated. If Cp = 1 then approximately 3 in every 1,000 will be outside the specification. This means that values of Cp greater than 1, say 1.5 or even 2.0, are desirable. Process Capability Index A Cpk value, called the process capability index, may also be helpful as this takes into account the accuracy, ie. The location of the mean, of the process. Cpk = UL mean/3 std dev or mean-LL/3 std dev whichever is the smaller.(UL Upper Limit and LL Lower Limit) (Mary-Clare Bushell 2011:108) This tool can be used to predict what portion of the overall population of product produced will fall outside of the customers specification limits and thusresult in a defect. Process Capability Analysis can also be used in other instances as well. For example,Process Capability Analysis can be the starting point of a continuous improvement project. In this way, The Process Capability Analysis can establish the baseline for your process and it can help guide you in how your process needs to be improved. 8D methodology: This has gained massive popularity over the time, since this happens to be one of the most successful problem solving approaches. Production can come across several issues and problems during their manufacturing period, regardless of the solid planning and preparation. This is a particular approach that puts a team in place for planning any rectification task. The principle idea behind this is to identify root of the problem and developing solution consecutively. As the name suggests, there are 8 fundamental stages starting from D1 to D8, these steps are shown briefly underneath; D1: Forming the team to be involved in the investigation. A team that has cross functional skilled team players would always be better in achieving results. However, the team should be enough to deal with the situation. This would include a Champion, Facilitator, Time Keeper, Team Members & Scribe. D2: Describing the problem description; including boundaries, characteristics & urgency. Is/is not matrix may be useful D3: Interim containment action; specify what, where, who and when by. This act ultimately protects the client before the final correction to the machine setup etc. has been made. D4: This is about identifying and verifying the root cause along as it is vital to identify the root cause before eliminating it. Tools such as Cause & Effect diagrams, 5 Why Analysis & Brainstorming may be used. D5: This is the time for corrective actions that would be permanent; once the root cause is identified and evaluated, this could be mistake proofing, procedural, tooling or a program change for example. D6: Once the issue is eliminated, the corrective action has to be validated and made permanent. This can be achieved through performance measuring. D7: Preventing recurrence; through lessons learned, review meeting & problem-solving boards. Checking whether similar work could be affected in the same manner D8: Upon successful completion and despatch of the conforming products, the team members must be congratulated for their contributions. 5. Evaluation of results There is best practice for the same purpose of monitoring and measuring and which is shown underneath. The pyramid shows four fundamental stages of a modern approach for enhancing the quality of the finished product; This process starts from the very bottom working to the top of the pyramid as below; Process Foundation where the preventive controls would be applied well in advance of machining. Various tools can be used here using a ideally a cross functional team to brainstorm what possible problems could occur and how to control these. Process Setting during process setting, the machines would be inputted with predictive controls such as correct tooling and feed/speeds for cutting with the measurements maybe originating from cad/cam files in various formats from the client or technical drawings. In-Process Control Moving to in process control, during the process, active controls such as statistical process control techniques are utilised as best practice. Post Process Monitoring this is known as the informative control final stage of the whole process. Whereby SPC data could be reviewed searching for trends within the process and looking towards making continuous improvements. Continuing on from above, the following shows how PDQ Engineering Ltd compare to the four fundamental stages; Quality tools are not used PDQ at this stage, a formal contract review incorporating also pre-production review is relied upon Comparable with best practice above In-process tally checks are utilised demonstrating ie. 1 in 10 checks over a certain batch size. PDQ use a sampling plan which has been discussed previously to give representative information at final inspection to prevent customer rejects. Any deviation from specification is investigated using 8D methodology. 5.1 Conclusion There practically is nothing wrong or faulty with the current process, however it would be substantially more effective, if the in-process time based statistical process control was introduced existing process to have clear control limits established within the drawing spec to control the process more. Also the current process is a little light on preventive controls, this would benefit PDQ by dedicating additional resources at the front end of the process which should in theory along within more modern in-process monitoring reduce any problems found at final inspection or ultimately in the field which will prove to be more costly. There is one main pro and con with this; Pro Shifting from practice to industry provides us an opportunity towards utilizing all of our best skills to create a distinctively proactive environment. Con -The culture shock of focussing on bottom pyramid first with preventative thinking and introducing control limits as oppose to full spec in-process, resistance to change will need to be overcome by engaging employees 6. Recommendation The two main recommendations for improvement to the current process for monitoring & measuring would be the following tools covering preventive and in-process methods; FMEA: which stands for failure mode and effects analysis. It is an analytical approach for determining all the possible failures that might take place within processing of a component. Failure modes refer to the modes through which the process can lead to its failure. Effects are the methods that these types of failures might lead to harmful outcomes, waste or defects for the customer. FMEA is created with the aim of limiting, identifying and prioritizing all these failure modes. It helps in enhancing good engineering by using the experience and knowledge of a cross functional team in the formation of the FMEA plan with the main aim of identifying and reducing risk. See steps of FMEA below; 1. Identify the product or system components, or process function. 2. List all possible failure modes of each component. 3. Set down the effects that each mode of failure would have on the function of the product or system 4. List all possible causes of each failure mode 5. Assess numerically the failure modes on a scale from 1 to 10. Experience and reliability data should be used, together with judgement, to determine the values, on a scale 1-10 for: P the probability of each failure mode occurring(1 = low, 10 = high) S The seriousness or criticality of the failure ( 1 = low, 10 = high) D the difficulty of detecting the failure before the product, or service is used by the consumer (1 = easy, 10 = very difficult) 6.Calculate the product of the ratings, C = P x S x D, known as the criticality index or risk priority number (RPN) for each failure mode. This indicates the relative priority of each mode in the failure prevention activities. 7. Indicate briefly the corrective action required and, if possible, which department or person is responsible and the expected completion date (John S.Oakland 1993:239) SPC: This isnt something new to the industry, but in PDQs case introducing the SPC as a time considering process check over different dimensions will be highly effective. This would help the supervisor to ensure high levels of quality during the production process when aimed at high volume production. The major steps included in a statistical process control are planning and collection of data. Then there must be suitable analysis of data collected because the statistical analysis of the wrong and improper data is useless. Statistical Process Control (SPC) is essentially, in-process inspection, this means monitoring the process as it takes place by periodically inspecting samples and plotting the results on a chart (Mary-Clare Bushell 2011:125) A control chart is a graphical tool that allows you to visibly track variation in a process over time.It is important to monitor changes in process variation to control the process. A process must be in statistical control before you can improve it. A process is said to be in a state of statistical control, or in control when measurements from the process vary randomly within statistically calculated limits. That is, there are no points outside the limits and no points forming trend lines, shifts, cycles, or other patterns. Over time, the variation present is consistent and predictable. A process that consistently and predictably produces product or service within three standard deviations, or +/- 3 sigma or 6 sigma (the statistically calculated control limits), of the mean is considered to be in a state of statistical control. This means that all the special causes of variation within the process have been removed (Jeremy Hazel, Jose Dominguez, James w.Collins, Jr.Dolores Steiger 2016:59) 6.1 Implementation plan Making changes to complement the current process can be done at any point of time, however there must be substantial space made for discussions within PDQ for the Quality Team to talk to the supervisors and machine operators then with the client to grasp the idea as vehicle for improvement to benefit all interested parties. There are a number of external training courses available with the most comprehensive being provided by Industry Forum Ltd. Core Tools Training used by the automotive industry would be the best choice for the key members of quality team to attend. The course is a one week full time course, it consists of the following elements; FMEA Control Plans plan developed from the FMEA to control CTQ features through SPC techniques MSA measurement systems analysis conducted prior to SPC for more reliable data SPC Control Plans and MSA are additional tools which will fit in perfectly with the main two recommendations as discussed previously. Overall implementation timescale expected to be within 3 months( see Gantt chart below from week 33-48, the implementation plan will also fit in well with potential plans for a PPAP (Pre Production Approval Process) on new products in this industry as well . 7. References Mary-Clare Bushell (2011).Monitoring & Measuring for Quality Joseph A. De Feo:Jurans Quality Handbook: The Complete Guide to Performance Excellence, Seventh Edition. Chapter(McGraw-Hill Professional, 2017), Industry Forum Training Publication (2012): Problem Solving Training John S.Oakland (1989).Total Quality Management John S.Oakland (1993).Total Quality Management: The Route To Improving Performance W.Edwards Deming(1986).Out of Crisis Jeremy Hazel, Jose Dominguez, James w.Collins, Jr.Dolores Steiger(2016). The Memory Jogger, ISO 9001:2015

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