Quality Assurance Vs Quality Control

The above general flow breaks down Quality Assurance vs Quality Control. Quality Assurance includes the Quality Control processes, Product Quality and other Quality Management business systems. Quality Assurance improves, supports and audits all of the companys systems, manufacturing processes and product. Quality Control focuses on monitoring, improving, and auditing the manufacturing proces and product. Quality Assurance Quality Assurance Definition : The planned and systematic activities necessary to provide adequate confidence that the product or service will meet the given requirements. Quality Control Definition The operational techniques and individual activities that focus on controlling or regulating processes and materials to fulfill requirements for quality. The focus is on preventing defective products or services from being passed on. Quality Systems Definition The defined organizational structure, responsibilities, processes, procedures and resources for implementing and coordinating the QA and QC functions. Calibration Definition The comparison of a measurement instrument to a measurement instrument of known accuracy to detect any variation from the required performance specification Quality Assurance monitors, improves and / or audits: Document Control Document Change Control Calibration Gage R&R Corrective Action Auditing Systems Interaction Map Quality Objectives Training Preventive Maintenance Job Descriptions Purchase Order Process Preventive Action Quality Plans New product introduction Quality Management Review Failure Mode Effect and Analysis Contract Review QA Org Chart Risk Management

Quality Control What is quality control? Quality control are the systems in your company that detects defects. Quality control prevents customers (internal and external) from receiving defective products. This includes inspection points for receiving inspection, inprocess inspection and final inspection. When establishing these systems you need to consider these items The procedure for inspection 1. The sampling plan for inspection 2. The quality record for inspection 3. The accept / reject criteria or specification. 4. The plan for handling and identifying the defective material 5. The review and corrective action of the defective material (MRB) Quality Control monitors, improves and / or audits: Identification and traceability Non Conforming Material Control Final Inspection Receiving Inspection Process Inspection Shipping Inspection Statistical Process Control. Quality Records Raw Material Control Finish Goods Control Product Reliability Material Review Board Control Plans. Receiving Inspection Receiving inspection are the controls you use to prevent defective materials from entering your production lines. Your company decides which materials are critical to your process. Critical materials directly affect product quality. These materials must be controlled. Consider these questions when creating your receiving inspection procedure. 1. How are the materials inspected? 2. What is the inspection procedure? 3. What is the sampling plan? 4. Where is the inspection documented? 5. How is the accepted material distinguished differently from the rejected material or unqualified material? 6. What happens to rejected material? 7. What is the process of notifying the supplier of rejected material? 8. How do you prevent good and rejected material from being mixed? 9. What is the staging process for unqualified material? Inprocess inspection You might have inprocess inspection in various departments in your company as production is flowing through those departments. This could include Inspecting machine settings, Inspecting machine output Inspecting the incoming material Inspecting the outgoing material Statistical Process Control .

When establishing an inprocess inspection stage consider these items Do you need the inspection to ensure the quality of the part? Do you have a operating procedure for the inspection tool? Do you have specifications for the inspection? Have you consider SPC for the inspection? Have you determined the sampling plan? Is there a quality record for the inspection? Is someone reviewing the quality record? Is there a Material Review Board process if issues are found? Who is notified when issues are found? Is production stopped when defects are found? Final Inspection Final inspection should occur on the product prior to shipping to the customer or prior to storing in inventory. When implementing final inspection activities, review the above inprocess inspection information. Final inspection is more dependent on customer requirements. The customer may have a specification or a drawing. Perhaps you are selling to a catalog or web page. Final inspection assures the customer is receiving the items they order. Final inspection occurs on the product. If defects are found, then the product may need to be reworked or scrapped. Finding defects at this time can cost your company serious money because the process that caused the defect may still be making the same defect on fresh product. In addition all value added steps have been placed in the product. All money spent on creating that product will be wasted if the product is scrapped. As a preventive measure, final inspection should review the inprocess inspection documentation to assure that the data is in order. Documentation for final inspection should be formal as the customer may ask for the data. Design The quality record so it meets your customer requirements and formats. If the customer is asking for the data, be sure to get their acceptance to the format prior to sending the initial data to the customer. What is Quality Control inspection types? Mechanical - These are dimensional measurements of the item Performance - This is an inspection for the function(s) of the product. Visual - Looking for certain undesirable characteristics. These characteristics need to be defined Quality Assurance Form = Quality Record A Quality Assurance form or a Quality Record defined: A document that states results or shows evidence of performed activities. Examples : Here is a list of Quality Record examples: 1) Inspection results 2) Traceability records 3) Product realization plans 4) Quality Objective charts 5) Customer communication email 6) Management review results 7) Product performance data 8) Process performance data 9) Calibration reports 10) Training records 11) Corrective Action reports 12) Preventive Action reports 13) SPC data 14) New product review results

15) New product verification results 16) New product validation results 17) Improvement plans 18) Interview summaries 19) Employment applications 20) Contract review forms 21) Purchase orders 22) Audit reports 23) Design inputs 24) Design outputs 25) Design reviews 26) Customer satisfaction surveys 27) Preventive action form 28) Statistical studies 29) Trend analysis How you handle a Quality Assurance Form or Quality Records. Records demonstrate the Quality Management System is effective and operating as prescribed by your documented systems. A record must be readable, identifiable (it states its purpose) and retrievable. In addition it is recommended that every form include a date and employees identification. You need a documented procedure that discusses how you handle a Quality Assurance Form or Quality Records. This procedure needs to cover: Form Identification Storage Protection Retrieval method Retention period. Disposition after retention The procedure can be a spreadsheet with the above headers. Group records together into categories. Inspection records may include final inspection, in process inspection, receiving inspection, audits and SPC. HR records may include applications, interview summaries and training. Auditing Records An auditor, internal or external, reviews records to find objective evidence of your inspections and your quality management system inputs and outputs. The records may be digital or handwritten. Dr. Edward Deming, a quality guru, created a famous cycle for implementing change. It is called Plan-Do-Check-Act or the PDCA cycle. Although the ISO 9001 standard doesnt explicitly state PDCA, it integrates this practice throughout the standard. Quality records are needed for the Plan and Check phases. Maintaining Quality Assurance Form(s) also known as Quality Records is critical to successful ISO 9001 registration. SPC Definition SPC Definition: SPC stands for statistical process control. Statistical Process Control is a scientific visual method used to monitor, control and improve processes by eliminating special cause variation from manufacturing, service and financial processes. SPC is a key continuous improvement tool. SPC is also a fundamental tool in six sigma methodology.

SPC Chart Described The X bar is the top chart. The cross hairs represent the average over time. The most recent data is on the right hand side of the chart. There is a UC line and an LC line which stands for upper control limit and lower control limit. These limits are calculated based on the overall average of the chart and the average range. In the center of the X bar chart there is an mean line which is the average of all collected data. The R chart is the bottom chart. The cross hairs represents the range of each data set. They correlate with the cross hairs on the top chart. There is an UC line (and sometimes a LC line) is dependent on the average range of the sample size. The Y axis for the X bar chart is the average of the sample. The Y axis for the R chart is the number for the range of the sample. Typically you sample 1 to 8 parts at a set frequency period. You then take the average of the sample size and plot it on the X bar chart. You plot the average in sequence, so the next point will be the furthest to the right. You then take the range of the sample size and plot that on the bottom R chart. SPC Calculations Prior to conducting SPC calculations for the X bar and R chart make sure you gather your data. When gathering the data keep in mind these guidelines. Select a sample size from 2 8 parts*. Collect at least 25 groups of samples Take the data over a period of a couple days Select random lots and parts Select random operators and machines. Plot the data on a histogram and assure the data is normally distributed. Do not change the sample size after you start collecting your data and plotting the points. Limit Calculations 1) For each group of samples calculate the mean and the range. 2) Calculate the overall mean which is know as 3) Calculate the mean of all of the ranges. This is known as 4) Now you are ready to calculate the limits. See below for the equations

Here is the table for the constants. The constants depend on your sample size.

SPC and Special Cause Variation If you study SPC charts you see most of the data is close to the average with some of the data away from the average. The plotted points are random. Half of them are above the average and half of them are below the average. This is the expected look of a chart when the process is in control. A SPC chart tells you when your process is out of control. Out of control means there is a special cause that was not there before. This could be an operator setup issue, wrong tooling, a change in raw materials or any unusual noise that can be investigated and eliminated. By knowing the SPC definition and how to use the charts you improve your processes because it directs you to finding problems exactly when they occur. You can eliminate the noise before process significantly changes. This prevents defects from occurring and costing your company serious $$. Quality Assurance Metrics Quality assurance metrics are quality objectives. They mean the same thing. Quality Objectives Documentation Your quality objective documentation should Tell specifically what you are measuring State how you collect the data. The frequency of the measurement Provide targeted goals State who is responsible for gathering the data State how they are recorded. State when they are reviewed . Quality Objectives Must Be measurable Relate to your business products documented reviewed tracked

Quality Objective examples Examples of Quality Objectives: Percent yield for a product Cycle time for a product. CpK for a given process characteristic CpK for a product characteristic Number of product returns Product returns parts per million. Corrective action cycle time Number of open corrective actions Number of audit action items. Sales Volume Net profit inventory turns Number of key customers. installation time Number of preventive actions Quality Costs. Number of supplier rejects Key supplier lead times Number of data entry errors Rework costs. Defect costs. Number of processes out of control . Determining Objectives When determining metrics, select metrics that are global to the entire operation. Then select metrics that support those global metrics. Break the metrics down by department, process, organization function or product. The metrics have to be agreed upon. A management committee determines the metrics. Senior managment communicates these metrics through out the company. All employees should be able to identify the metrics. All employees should know how their work affect the metrics. Make metric targets reasonable and challenging. Management provides the plans to achieve the targets. During the quality management review, review the metrics and document the plans to achieve the targets. Some companies put the quality objectives within the quality assurance manual. I do not recommend this. Your customers do not need to see your quality objectives. In most cases these are confidential. Quality Assurance Program Plan Level 1 Systems We present the quality assurance program plan of these systems below. Click the links below to find additional information that should be included in a documented system. Systems Defined A System is a set of interrelated or interacting elements. A Management System establishes policy and objectives to achieve those objectives. A Quality Management System is a management system to direct and control an organization with regards to quality. A Quality Management system includes elements from several processes. These processes lie within a business department or between departments. When creating a Quality Assurance system these items must be kept in mind:

It must be documented. Involve all stakeholders during the creation. All employees must follow the system. It must be open to audits. It must be rigid to prevent users from deviating yet It must be flexible to allow for continuous improvement. The data or information necessary to support the system should be centralized.

Product Knowledge Product Knowledge is listed as the first item in the quality assurance program plan. Product Knowledge is very important to capture prior to reviewing, improving or creating the other systems listed. If you are new to the business we recommend you gather all the available information about your companys product. Collect this information from: Product Catalogs Company Website Customer specifications Industry specifications Other employees As your develop your systems, include Product Knowledge background in new employee training. Document Control Document Control is the spine of your QA program. Without a detailed Document Control system, your other systems could possibly be out of control. All Quality Assurance Systems must be documented. A Document Control procedure dictates the method to document those systems and all other procedures When creating a Quality Assurance program plan, the first system must be the Document Control System. This is the second item shown on the Quality Assurance Overview and it is a critical system. As a member of the Quality Assurance organization you understand, follow and teach the Document Control system to other employees. In addition, you frequently audit this system. Your familiarity is important.

Final Inspection Final Inspection assures the product Quality. Write Final Inspection procedures for your products. Train the final inspectors to follow these procedures. Final inspection occurs just prior to shipping the product. The results of final inspection will be a quality record. Calibration Calibration assures that the measurement equipment throughout your facility measures within expected tolerances. Without a Calibration system the data recorded from the product or process inspection is suspect. Traceability A Traceability System documents your methods for tracking the finished goods through the raw materials. This includes tracking process steps, machines and employees. When finding the root cause of a problem, product traceability provides direction. Corrective Action Corrective Action is your company's policy for customer complaints. Customers may request this policy. They want to be included in the communication loop during the open complaint period. They want to know your tracking methods, response time frame and responsibilities. In many cases your customers requirements will drive this policy. The policy must also cover internal Quality issues. Non Conforming Material Control Non Conforming Material Control instructs employees the correct methods to identify defective material. It assures you don't send defective material to your customer. It prevents defective material from entering into the manufacturing process. Organizational Chart An Organizational Chart shows your employees and your customers the company's management structure, the lines of communication and general responsibilities. Be sure to create an org chart that shows your Quality Assurance organization. This is the last item from the Quality Assurance Overview and in small companies it may not be a priority. Quality Program Management Review The Quality Program Management Review is critical and necessary for ISO 9001 certification. Not only this, but when done properly, it drives extensive improvement throughout your business. In theory, the QMS review output creates the plan for implementing, changing and improving your quality program. QMS Review Frequency: According to the ISO 9001 standard, the quality management system must be reviewed on a periodic basis. There are a couple of approaches to meeting this requirement. Annual Schedule Meeting Semi Annual Meeting Weekly Meeting If youre starting to implement the ISO 9001 system then the review should be a semi annual meeting. Meet twice a year until your system matures. This assures your company stays on track and does not lose focus from the standard. If your company has a mature system and does not expect many changes to the QMS operation then conduct an annual meeting. Instead of an annual or semi annual meeting, a management weekly meeting could be used. When taking this approach, track all input and output records. During these meetings cover the inputs for the Quality Program Management Review and record the action items. You do not need to

cover all input requirements during each meeting, however you must prove (provide documentation) that you do access the input requirements on a regular basis. Quality Program Management Review Procedure I recommend creating a procedure that documents the management review process. Within the procedure discuss the frequency, the required management team, the mandatory inputs, the outputs and your quality records. This makes it easier for you to assure you meet the requirement. Note, this procedure is not absolutely necessary for ISO certification. See here for a list of required procedures. If you choose not to maintain a procedure, then be sure to keep your quality records for your auditors evaluation. Quality Program Management Review Team When the ISO 9001 standard uses the word Review, this means that a team analyses the inputs and the team makes the output plan. For the review, employ a cross functional team approach. When selecting the team members, include your senior management. I recommend taking a look at your organizational chart and select the top 2 or 3 management levels for your given location. The top 2 or 3 tiers are the people who belong on the quality management review team. Include managers of these functions during the QMS review meeting: President or Operations Manager Quality Assurance Manager Engineer Manager Facilities Manager Production Manager Purchasing Manager Sales Manager . QMS Review Inputs The team discusses and evaluates the inputs during the quality program management review. The inputs are actual quality records which accumulated since the last management review meeting. Below is a list of necessary inputs: The output (plan) from the previous QMS Review customer feedback process performance data product conformance data quality metrics quality policy Key process areas from the interaction chart corrective actions changes that could affect your quality management system Improvement recommendations risk management issues (medical devices) QMS Review Outputs The output is a list of action items that addresses the inputs. Document this on a gantt chart or a to do list. For each action item, include the following action item or task person responsible due date state if it is an improvement, preventive or corrective action measure. On the final report, collect signatures of each team member and record the date of review.

QMS Documentation Collect all the input data and the final output report and place this information into a folder or binder. Label the binder with QMS review and the date. Your auditor will assess this package. Quality Audit Checklist A quality audit checklist is a quality record that tracks the questions and responses during a quality audit. The quality audit is a valuable tool for continuous improvement. Audits ensure your quality assurance system is sound. Audits are also necessary for ISO 9001 registration. To create an audit checklist, first reflect on the reason behind the audit. What kind of audit will it be? What audit category are you examining. See below. Types of Audits 3rd Party Audits 2nd Party Audits 1st Party Audits 3rd Party Audit are done by an outside independent audit organization. In case of an ISO 9001 audit the independent organization is the registrar. They normally do not have an interest in the final outcome. The 3rd party could be a registrar, government employee, or a firm hired by the company. The result of the audit could be a certification, license, acceptance, or an award. 2nd Party Audit are Audits from those who have a deep interest in the final outcome. This could be you auditing your suppliers, or your customers auditing you. The audit could be called a survey or an assessment. 1st Party Audits are audits done internally. They are a management tool with the emphasis on continuous improvement. The auditor(s) must be independent of the audit area. The audit should be aligned with the company goals and metrics. Audit Categories System Audit Conformance Audit Compliance Audit Process Audit Product Audit Department Audit System Audits are looking at a particular system which includes multiple processes and can spread across several employees and departments. The audit of your calibration system can be consider a system audit. Your interaction chart lists your systems. Conformance Audits are audits to define system requirements. These are global in nature. For example a 3rd party audit of your ISO 9001 system is a conformance audit. Compliance Audit is an audit to regulatory requirements. This includes government agency audits. Process Audit is a focused audit on a set of processes within your organization. It examines adherence to procedures and specifications during production or service activities. Product Audit is a focus audit on the product itself. This may be an inspection activity or an out of the box audit. Department Audit is a focus audit on one department that looks at the processes, specifications, and systems in one department only. It will look at the different operations with in that department. It will also examine department organization and training.

Audit Stages Determine the audit focus Prepare for the audit Perform the audit Report the findings in the initial findings report Determine the corrective action Update the findings report with the corrective action Conduct the corrective action Update the findings report when actions are completed Follow Up Closure The audit focus is dependent on the organization needs. If it is a system audit, use your interaction chart to determine the system focus. If there are many problems with a particular process then conduct a process audit on that process. If there is a department with many issues then conduct a department audit. You may want to issue an internal audit engagement letter to the auditee. During the audit preparation, determine the quality audit checklist. This checklist is the audit plan. During preparation, review the procedures, standards, specifications and / or work instructions. These documents help you determine the quality audit checklist. Record audit questions on the checklist. During the audit performance follow these guidelines Do not be biased Keep an open mind Do not be argumentive Be patient Remind the participant that the audit is for continuous improvement Always state the facts Do not correct the person on the spot. Report accurately and clearly Be familiar with the procedure During the initial finding report, document the issues found. State the facts and provide evidence. Use names and demonstrate the findings. Show quality records for evidence. Apply the quality audit checklist as the basis for the findings report. After the initial findings report, provide a copy to the corrective action team. Have a corrective action team meeting to issue the corrective actions. Document the corrective actions on the findings report. Be sure responsibilities and due dates are assign for the actions. The team will then complete the corrective actions. Document the completion of the corrective actions on the findings report. When all actions are completed, close out the report. Audit Schedule Predetermine the management systems audit schedule. Use your interaction chart to establish the necessary systems to schedule. I recommend not scheduling out all of the system audits. Instead keep a 3 to 6 month schedule and update this every month. This will allow you to audit the concerned areas. I also recommend using a software application to track your audits. The software can track audit questions, schedule, results, and corrective action. Quality Audit Benefits It drives continuous improvement Lets management know problems or potential problems Provides input into management decisions Accesses training and effectiveness Shows management support of the quality program Verifies compliance.

Quality Audit Mistakes These mistakes prevent an effective audit. Auditing with the gotcha attitude Finding faults and not facts Not recognizing that the audit is people focused Not properly defining the purpose and scope Not using a quality audit checklist Not issuing corrective action Not conducting follow up on the corrective action Not using a team approach to issuing corrective actions . Internal Audit Plan The internal audit plan consist of particular questions that you ask during the audit. These questions provide insight into your QA systems. The audit plan could cover a system, process or department audit. The plan references your organization systems, or the ISO 9001 element for each question. The plan could cover an element from your interaction chart. The audit plan is a document that list the planned questions. A final report references the internal audit plan and provides the answers to those questions. Here are some questions that I like to quiz employees during an departmental ISO 9001 audit.

Open End Questions Tell me about the quality policy. What quality objective do you affect? How do you know these procedures are OK to follow? Tell me about your work process. Show me this process in your procedure. What is the specification for this inspection? What do you do when you find a defective part? What is the traceability for this product? Show me how you record the inspection. How do you know this product is good? What do you do when you see an out of control point? How do you order supplies? What do you do when you encounter a production problem? What type of training have you received? How do you know if this measuring equipment is ok to use? What do you do when a piece of equipment breaks down? These are open end questions for the internal audit plan ,

Yes / No Questions Do employees know the quality policy? Do employees know the quality objectives and understand them with regards to their function? Do employees know where their procedures are located? Are all procedures and specifications controlled? Are all forms current in the department? Do employees know what is the most current revision of the document? Can employee identify which documents cover inspection? Can employee identify which documents contain the specifications? Does employee know the specifications for the critical parameters? Do employees know when changes are made to the process? Do employees follow the inspection procedures? Are the inspections documented? Are inspection records completely filled in? Do inspection records results agree with specification requirements? Can employees locate the procedure for the equipment or process they are conducting? Does the procedure for the equipment or process actually reflect employees methods? Do employees send parts to MRB when inspection does not meet specifications? Can the parts be tracked to all raw materials? Can employee describe how to select next work item? Does employee know the process on ordering goods? Does employee know the approval process for a purchase order? Is the equipment in the PM (Preventive Maintenance) system? Are there records for PM? Are all critical raw materials labeled with accept stamps or traceable to an accept stamp? Have all critical raw material been inspected and approved? Are all measuring equipment labeled with measurement status? Are all calibrations within due date? Do employee know if testing equipment is OK to use? Do calibration records reflect findings for the equipment? Do employees know what to do with non conforming parts? Are production status labels properly used? Are storage containers properly labeled? Are there training records for each employee? Is the training effective? Are employee training needs determined? Are training needs being addressed by the supervisor? Are employees involved in continuous improvement teams? Do employees know what to do when an out of control condition exists? Is department clean? Does operator maintain cleanliness? Are employees following safety procedures? Do employees know where the MSDS are located? Are employees properly storing tooling? These are yes / no questions for the internal audit plan .