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6 Quality Management (MGT 424) In chapter 10, we have discussed the quality audit process as one of the company tools to verify its compliance with the identified quality standards. Based on what you have learned, you are required to do the following: 1- As external or internal quality auditor, choose a system, product, product or service that you wish to apply a quality audit process on. 2- Based on the steps mentioned in our course materials: • Identify the audit scope and objectives, type of the audit, duration, team members. • Identify the methods used during the quality audit process (qualitative – quantitative data). • Your observations (issues and its consequences) as the main auditor. • The proposed corrective actions (recommendations). Mention at least two. • The follow up procedures. • References. Instructions : Organize your answers as mentioned above. The word limit (500 – 600 words), word document. Use your creativity, textbook, and online sources as needed (cite all used resources) references at least 2 4. please use your own words don’t copy and paste (no plagiarism) 5. All answered must be typed using Times New Roman (size 12, double-spaced) 6. I want answer with APA reference, references at least 2 1. 2. 3. Chapter 10 Quality Audits Quality Audits According to the text • An audit is a comparison of observed activities and/or results with documented requirements. • The evidence provided from audits forms the basis of improvement in either the element audited, or in the requirements. Quality Audits According to the text • ISO 19011, Guidelines for Auditing Quality Systems, defines a quality audit as a systematic, independent and documented process for obtaining audit evidence (records, statements of fact or other information, which are relevant to the audit criteria and verifiable) and evaluating it objectively to determine the extent to which the audit criteria (set of policies, procedures or requirements) are fulfilled. Quality Audits • Three types of quality audits ➢ Systems ❖ System audits are the broadest audits in terms of scope. ❖ Quality systems are the most commonly audited. ➢ Products ❖ Product audits are performed to find out if the system did its job and produced the results it was expected to produce. ➢ Processes ❖ “Process audits are conducted to verify that the inputs, actions, and outputs of a given process match the requirements.” Quality Audits • Product Audits ➢ Conducted from the customer perspective ➢ “ISO 9000:2000 divides products into four generic categories: ❖ ❖ ❖ ❖ Hardware Software Processed materials Services” ➢ “ISO 9000 defines four facets of product quality: ❖ quality due to defining the product to meet marketplace requirements ❖ quality due to design ❖ quality due to conformance with the design ❖ quality due to product support.” Quality Audits • Process Audits ➢ Specific activities in organizational units ➢ “Process audits compare the actual operations with the documented requirements of the operations.” ➢ “Process audits should begin with an understanding of how the process is supposed to operate.” Quality Audits • System Audits ➢ Arrangement of processes ➢ “Systems audits concentrate on the relationships between the various processes in the system.” ➢ “In the case of quality audits, the concern is with the quality system. The quality system is the set of all activities designed to ensure that all important quality requirements are determined, documented, and followed.” Quality Audits Planning and Conducting the Audit • Audits are usually pre-arranged. • Pre-arranged audits are less disruptive to the operations cycle. • Documentation can be reviewed prior to the audit onsite. Quality Audits Planning and Conducting the Audit • The following are timings for audits: ➢ Pre-award audit ➢ Surveillance audit ➢ Contract renewal ➢ Problem resolution ➢ In-process observation Quality Audits Planning and Conducting the Audit According to the text, the following are steps in preparing the audit: • Choose the audit team. Verify that no team member has a conflict of interest. • Meet with the audit team and review internal audit procedures. • Discuss forms to be used and procedures to be followed during the audit. • Perform a desk audit of the quality manual and other documentation to verify the scope of the audit and provide an estimate of the duration of the audit. Quality Audits Planning and Conducting the Audit • • • • • • • • • Assign audit subteams to their respective audit paths. Contact the auditee and schedule the audit. Perform the audit. Write corrective action requests (CARs) and the audit summary report, listing the CARs in the audit summary. Conduct a closing meeting (exit briefing). Issue the audit summary report. Present the complete audit findings, including all notes, reports, checklists, CARs, etc., to the quality manager. Prepare a final audit report. Follow up on CARs. Quality Audits Planning and Conducting the Audit • Formal audits include: ➢ ➢ ➢ ➢ ➢ ➢ ➢ ➢ ➢ ➢ ➢ ➢ ➢ ➢ Audit purpose and scope Audit observations Conclusions and recommendations Objectives of the audit Auditor, auditee, and third-party identification Audit dates Audit standards used Audit team members Auditee personnel involved Statements of omission Qualified opinions Issues for future audits Auditee comments on the report (if applicable) Supplementary appendices Quality Audits Product, Process, and Materials Control According to the text • Work instructions must establish quantitative or qualitative means for determining that each operation has been done satisfactorily. • These criteria must also be suitable for use with related inspections or tests, because work instructions serve operating personnel, supervisors, inspectors, managers, and even customers. • Work instructions include the documented procedures that define how production, installation, or servicing will take place. Quality Audits Product, Process, and Materials Control Work instructions should include: • • • • • • • • • • The manner in which the work will be done The equipment needed to do the work The working environment Compliance with other procedures and documents Process parameters to be monitored and how they will be monitored (e.g., checklists, control charts) Product characteristics to be monitored and how they will be Monitored Workmanship criteria Maintenance procedures Verification methods (process qualification) Quality Audits Classification of Characteristics • Characteristics are usually classified as: ➢ Critical ➢ Major ➢ Minor ➢ Incidental The Handbook for Quality Management 00_Pyzdek_FM_pi-xii.indd 1 11/16/12 6:09 PM About the Authors Thomas Pyzdek is a Six Sigma consultant with more than 40 years of experience in the field. His clients include Ford, McDonald’s, Intuit, Boeing, Seagate, Avon Products, and many other companies. Mr. Pyzdek is a recipient of the American Society for Quality Edwards Medal for outstanding contributions to the practice of quality management and the E.L. Grant Medal for outstanding leadership in the development and presentation of meritorious educational programs in quality. He has also received a Lean Six Sigma Leadership award from the American Quality Institute. Paul Keller is president and chief operating officer with Quality America, Inc. He has developed and implemented successful Six Sigma and quality improvement programs in service and manufacturing environments. He is the author of several books, including The Six Sigma Handbook, Third Edition (coauthor), and Six Sigma Demystified. 00_Pyzdek_FM_pi-xii.indd 2 11/16/12 6:09 PM The Handbook for Quality Management A Complete Guide to Operational Excellence Thomas Pyzdek Paul Keller Second Edition New York Chicago San Francisco Lisbon London Madrid Mexico City Milan New Delhi San Juan Seoul Singapore Sydney Toronto 00_Pyzdek_FM_pi-xii.indd 3 11/16/12 6:09 PM 09_Pyzdek_Ch09_p151-208.indd 208 11/21/12 1:42 AM CHAPTER 10 Quality Audits 10_Pyzdek_Ch10_p209-226.indd 209 11/16/12 4:55 PM 10_Pyzdek_Ch10_p209-226.indd 210 11/16/12 4:55 PM A n audit is a comparison of observed activities and/or results with documented requirements. The evidence provided from audits forms the basis of improvement in either the element audited, or in the requirements. Effective quality auditing can prevent problems by uncovering situations that, while still acceptable, are trending toward an eventual problem. The attention of management brought on by an unfavorable audit report can often prevent future noncompliance. ISO 19011, Guidelines for Auditing Quality Systems, defines a quality audit as a systematic, independent and documented process for obtaining audit evidence (records, statements of fact or other information, which are relevant to the audit criteria and verifiable) and evaluating it objectively to determine the extent to which the audit criteria (set of policies, procedures or requirements) are fulfilled. Review activities must meet several criteria to be considered audits. Informal walk-throughs, while useful, do not qualify as systematic evaluation, so do not meet the criteria for an audit. Examinations by employees who report to the head of the function being examined are also important, but are not audits. The reference to “policies, procedures or requirements” implies the existence of written documentation. Undocumented quality systems are not proper subject matter for quality audits. Implementation is audited by comparing the planned policies, procedures, or requirements with observed practices, with an eye toward whether or not (1) these are properly implemented, and (2) if so, do they accomplish the stated objectives? It is no surprise to find that an activity as important and as common as quality audits is covered by a large number of different standards. It is in the best interest of all parties that the audit activity be standardized to the extent possible. One of the fundamental principles of effective auditing is “no surprises,” something easier to accomplish if all parties involved use the same rule book. Audit standards are, in general, guidelines that are voluntarily adopted by auditor and auditee. Often the parties make compliance mandatory by specifying the audit standard as part of a contract. 211 10_Pyzdek_Ch10_p209-226.indd 211 11/16/12 4:55 PM 212 Process Control When this occurs it is common practice to specify the revision of the applicable standard to prevent future changes from automatically becoming part of the contract. Willborn (1993) reviews eight of the most popular quality audit standards and provides a comparative analysis of these standards in the following areas: • General features of audit standards • Auditor (responsibilities, qualifications, independence, performance) • Auditing organizations (auditing teams, auditing departments/ groups) • Client and auditee • Auditing (initiation, planning, implementation) • Audit reports (drafting, form, content, review, distribution) • Audit completion (follow-up, record retention) • Quality assurance Auditing standards exist to cover virtually every aspect of the audit. The reader is encouraged to consult these standards, or Willborn’s summaries, to avoid reinventing the wheel. Types of Quality Audits There are three basic types of quality audits: systems, products, and processes. Systems audits are the broadest in terms of scope. The most commonly audited system is the quality system: the set of activities designed to ensure that the product or service delivered to the end user complies with all quality requirements. Product audits are performed to confirm that the system produced the desired result. Process audits are conducted to verify that the inputs, actions, and outputs of a given process match the requirements. All of these terms are formally defined in several audit standards. Product Audits Product audits are generally conducted from the customer’s perspective. ISO 9000:2000 divides products into four generic categories: hardware, software, processed materials, and services. The quality system requirements are essentially the same for all product categories. ISO 9000 defines four facets of product quality: quality due to defining the product to meet marketplace requirements, quality due to design, quality due to conformance with the design, and quality due to product support. Traditionally, product quality audits were conducted primarily to determine conformance with design. However, modern quality 10_Pyzdek_Ch10_p209-226.indd 212 11/16/12 4:55 PM Quality Audits 213 audit standards (e.g., the ISO 9000 family) are designed to determine all four facets of quality. One purpose of product audit is to estimate the quality being delivered to customers; thus product audits usually take place after internal inspections have been completed. Product audits differ from inspection in the following ways: (1) audits are broader in scope than inspections, (2) audits provide more depth than inspections, (3) audits provide information useful for product quality improvement, and (4) audits offer another level of assurance beyond routine inspection. Inspection normally focuses on a small number of important product characteristics. Inspection sles are selected at random in sizes large enough to produce statistically valid inferences regarding lot quality. Audits, on the other hand, are concerned with the quality being produced by the system. Thus, the unit of product is viewed as representing the common result of the system that produced it. Audit sles are sometimes seemingly quite small, but they serve the purpose of showing a system snapshot. Audit sles are examined in greater depth than are product sles; that is, more information is gathered per unit of product. The sle results are examined from a systems perspective. The examination goes beyond mere conformance to requirements. Minor discrepancies are noted, even if they are not serious enough to warrant rejection. A common practice is to use a weighting scheme to assign “demerits” to each unit of product. Aesthetics can also be evaluated by the auditor (e.g., paint flaws, scratches, etc.). Table 10.1 presents an exle of a publisher’s audit of a sle of 1000 books of a given title. These audit scores are presented on histograms and control charts to determine their distribution and to identify trends. Product audit results are compared with the marketing requirements (i.e., customer requirements) as well as the engineering requirements. Product audits are often conducted in the marketplace itself. By obtaining the product as a customer would, the auditor can examine the impact of transportation, packaging, handling, storage, and so on. These audits also provide an opportunity to compare the condition of the product with that being offered by competitors. Problem Seriousness Weight Cover bent Major 5 2 10 Page wrinkled Minor 3 5 15 Light print Incidental 1 15 15 Binding failure Major 5 TOTAL Table 10.1 10_Pyzdek_Ch10_p209-226.indd 213 Frequency Demerits 1 5 23 45 Book Audit Results 11/16/12 4:55 PM 214 Process Control Process Audits Process audits focus on specific activities or organizational units. Exles include engineering, marketing, calibration, inspection, discrepant materials control, corrective action, etc. Processes are organized, value-added manipulations of inputs that result in the creation of a product or service. Process audits compare the actual operations with the documented requirements of the operations. Process audits should begin with an understanding of how the process is supposed to operate. A process flowchart is a useful tool in helping to reach this understanding. It has been said that a good reporter determines the answer to six questions: who? what? when? where? why? and how? This approach also works for the process auditor. For each important process task, ask: • Who is supposed to do the job? (Are any credentials required?) • What is supposed to be done? • When is it supposed to be done? • Where is it supposed to be done? • Why is this task done? • How is this task supposed to be done? The documentation should contain the answers to every one of these questions. If it doesn’t, the auditor should suspect that the process isn’t properly documented. Of course, the actual process should be operated in conformance to documented requirements. Systems Audits Systems are arrangements of processes: a group of interacting, interrelated, or interdependent elements forming a complex whole. Systems audits differ from process audits primarily in their scope. Whereas process audits focus on an isolated aspect of the system, systems audits concentrate on the relationships between the various processes in the system. In the case of quality audits, the concern is with the quality system. The quality system is the set of all activities designed to ensure that all important quality requirements are determined, documented, and followed. The level of requirements for quality systems varies with the type of organization being audited and, perhaps, with the size of the organization. Organizations that produce, distribute, and support a product have greater needs than organizations that sell a service. The changes made to the ISO 9000 series in 2000 delineated the requirements in broader terms that were more clearly applicable to most or all organizations. 10_Pyzdek_Ch10_p209-226.indd 214 11/16/12 4:55 PM Quality Audits 215 Internal Audits Considering the benefits that derive from quality auditing, it is not surprising that most quality audits are internal activities conducted by organizations interested in self-improvement. Of course, the same principles apply to internal audits as to external audits (e.g., auditor independence). Ishikawa (1985) describes four types of internal audits: • Audit by the president • Audit by the head of the unit (by division head, factory manager, branch office manager, etc.) • Quality control (QC) audit by QC staff • Mutual QC audit President’s audits are similar to what Tom Peters has called “management by wandering around” (MBWA). The president personally visits different areas of the organization to make firsthand observations of the effectiveness of the quality system. Audit by the head of the unit is equivalent to the president’s audit, except the audit is limited to functional areas under the jurisdiction of the head person. Quality control audits are conducted by the quality department in various parts of the organization. Unlike presidents and unit heads who are auditing their own areas, quality department auditors must obtain authorization before conducting audits. In mutual QC audits, separate divisions of the company exchange their audit teams. This provides another perspective from a team with greater independence. Two-Party Audits Most audits are conducted between customers and suppliers. In this case suppliers usually provide a contact person to work with the customer auditor. In addition, suppliers usually authorize all personnel to provide whatever information the auditor needs, within reason, of course. Twoparty audits are generally restricted to those parts of the quality system of direct concern to the parties involved. The customer will evaluate only those processes, products, and system elements that directly or indirectly impact upon their purchases. Third-Party Audits One problem with two-party audits is that a supplier will be subject to audits by many different customers, each with their own (sometimes conflicting) standards. Likewise, customers must audit many different suppliers, each with their own unique approach to quality systems design. Third-party audits are one way of overcoming these difficulties. 10_Pyzdek_Ch10_p209-226.indd 215 11/16/12 4:55 PM 216 Process Control In a third-party audit the auditing organization is not affiliated with either the buyer or the seller. The audit is conducted to a standard that both the buyer and seller accept, such as the ISO 9000 series discussed in Chap. 2. As the use of ISO 9000 becomes more widespread, the incidence of third-party audits will continue to increase. However, ISO 9000 audits are conducted at a high system level. Product and process audits will continue to be needed to address specific issues between customers and suppliers. Desk Audits The emphasis of the discussion above has been on the on-site visit. However, a significant portion of the auditing activity takes place between the auditor and auditee, each working at their respective organizations. A great deal of the audit activity involves examination of documentation. The documentation reveals whether or not a quality system has been developed. It describes the system as the supplier wants it to be. From a documentation review, the auditor can determine if the quality system, as designed, meets the auditor’s requirements. If not, a preliminary report can inform the auditee of any shortcomings. Corrective action can be taken either to modify the documentation or to develop new system elements. Once the documentation is in a form acceptable to the auditor, an on-site visit can be scheduled to determine whether the system has been properly implemented. Properly done, desk audits can save both auditor and auditee significant expense and bother. Planning and Conducting the Audit Most quality audits are pre-announced, which provides several advantages. A pre-announced audit is much less disruptive of operations. The auditee can arrange to have the right people available to the auditor. The auditor can provide the auditee with a list of the documentation he or she will want to review so the auditee can make it available. Much of the documentation can be reviewed prior to the on-site visit. The on-site visit is much easier to coordinate when the auditee is informed of the audit. Finally, pre-announced audits make it clear that the audit is a cooperative undertaking, not a punitive one. Of course, when deliberate deception is suspected, surprise audits may be necessary. Surprise audits are usually very tightly focused and designed to document a specific problem. In most cases, quality professionals are not trained or qualified to conduct adversarial audits. Such audits are properly left to accounting and legal professionals trained in the handling of such matters. Audits can be scheduled at various points in the buying cycle. The following timings of audits are all quite common: 10_Pyzdek_Ch10_p209-226.indd 216 11/16/12 4:55 PM Quality Audits 217 • Pre-award audit. Conducted to determine whether the prospective supplier’s quality system meets the customer’s requirements. • Surveillance audit. Conducted to ensure that an approved supplier’s quality system continues to comply with established requirements. • Contract renewal. Conducted to determine whether a previously approved supplier continues to meet the quality system requirements. • Problem resolution. A tightly focused audit conducted to identify the root cause of a problem and to ensure that effective corrective action is taken to prevent future occurrences of the problem. • In-process observation. On-site audits performed to ensure that processes are performed according to established requirements. These audits are often performed when it is difficult or impossible to determine whether or not requirements have been met by inspecting or testing the finished product. At times periodic audits are automatically scheduled. For exle, to maintain certification to the ISO 9000 series standards, an organization is periodically reassessed. Auditor Qualifications Willborn (1993, pp. 11–23) provides an extensive discussion of auditor qualifications. The first requirement for any auditor is absolute honesty and integrity. Auditors are often privy to information of a proprietary or sensitive nature. They sometimes audit several competing organizations. The information an auditor obtains must be used only for the purpose for which it was intended. It should be held in strict confidence. No amount of education, training, or skill can compensate for lack of ethics. The auditor must be independent of the auditee. In addition, auditors must comply with professional standards, possess essential knowledge and skills, and maintain technical competence. Auditors must be fair in expressing opinions and should inspire the confidence of both the auditee and the auditor’s parent organization. The auditor acts as only an auditor and in no other capacity, such as management consultant or manager. Managers of audit organizations should have a working knowledge of the work they are supervising. An auditor’s qualifications must conform to any applicable standards, and they must be acceptable to all parties. The auditing organization should establish qualifications for auditors and provide training for technical specialists. Some auditing activities, such as those of nuclear power plants, require special certification. Lead auditors require additional training in leadership skills and management. Third parties may also provide certification of auditors, such as by ASQ. 10_Pyzdek_Ch10_p209-226.indd 217 11/16/12 4:55 PM 218 Process Control Auditors should be able to express themselves clearly and fluently both verbally and in writing. They should be well versed in the standards to which they are auditing. Where available, this knowledge should be verified by written examination and/or certification. Auditors should master the auditing techniques of examining, questioning, evaluating and reporting, identifying methods, following up on corrective action items, and closing out audit findings. Industrial quality auditors should have knowledge of design, procurement, fabrication, handling, shipping, storage, cleaning, installation, inspection, testing, statistics, nondestructive examinations, maintenance, repair, operation, modification of facilities or associated components, and safety aspects of the facility/process. In a specific audit assignment, the knowledge of individual auditors might be complemented by other audit team members. Internal Quality Surveys as Preparation While quality audits are formal, structured evaluations involving independent auditors, quality surveys are internal, less formal reviews of quality systems, products, or processes often conducted at the request of internal management. The purpose of a quality survey is informational, so formal reports are generally not prepared. Rather, the survey results are presented in information-sharing sessions with concerned personnel. Quality surveys conducted prior to quality audits can assist the organization in preparing for the audit. Steps in Conducting an Audit Most quality systems audits involve similar activities. The checklist below is an adaptation of the basic audit plan described by Keeney (1995). • Choose the audit team. Verify that no team member has a conflict of interest. • Meet with the audit team and review internal audit procedures. • Discuss forms to be used and procedures to be followed during the audit. • Perform a desk audit of the quality manual and other documentation to verify the scope of the audit and provide an estimate of the duration of the audit. • Assign audit subteams to their respective audit paths. • Contact the auditee and schedule the audit. • Perform the audit. • Write corrective action requests (CARs) and the audit summary report, listing the CARs in the audit summary. • Conduct a closing meeting (exit briefing). 10_Pyzdek_Ch10_p209-226.indd 218 11/16/12 4:55 PM Quality Audits 219 • Issue the audit summary report. • Present the complete audit findings, including all notes, reports, checklists, CARs, etc., to the quality manager. • Prepare a final audit report. • Follow up on CARs. Audit Reporting Process Audit results are reported while the audit is in progress and upon completion of the audit. The principle is simple: the auditor should keep the auditee up-to-date at all times. This is a corollary of the “no surprises” principle. In addition, it helps the auditor avoid making mistakes by misinterpreting observations; in general, the auditee is better informed about internal operations than the auditor. Auditees should be informed before, during, and after the audit. Prior to the audit, the auditee is told the scope, purpose, and timing of the audit and allowed to play an active role in planning the audit. Upon arrival the auditor and auditee should meet to review plans and timetables for the audit. Verbal daily briefings should be made, presenting the interim results and tentative conclusions of the auditor. At these meetings the auditee is encouraged to present additional information and clarification to the auditor. Written minutes of these meetings should be maintained and published. Upon completion of the audit an exit briefing is recommended. As a matter of courtesy, an interim report should be issued as soon as possible after completion of the audit. The interim report should state the main findings of the auditor and the auditor’s preliminary recommendations. Formal audit reports are the ultimate product of the audit effort. Formal audit reports usually include the following items: • Audit purpose and scope • Audit observations • Conclusions and recommendations • Objectives of the audit • Auditor, auditee, and third-party identification • Audit dates • Audit standards used • Audit team members • Auditee personnel involved • Statements of omission • Qualified opinions • Issues for future audits 10_Pyzdek_Ch10_p209-226.indd 219 11/16/12 4:55 PM 220 Process Control • Auditee comments on the report (if applicable) • Supplementary appendices The audit report is the “official document” of the audit. Audit reports should be prepared in a timely fashion. Ideally, the deadline for issuing the report should be determined in the audit plan prepared beforehand. Audit reports should describe the purpose and scope of the audit; the entity audited; the membership of the audit team, including affiliation and potential conflicts of interest; the observations of the audit; and recommendations. Detailed evidence supporting the recommendations should be included in the report. Audit reports may include recommendations for improvement. They may also include acknowledgment of corrective action already accomplished. The formal report may draw upon the minutes of the meetings held with the auditee. It should also note the auditee’s views of previously reported findings and conclusions. Auditor opinions are allowed, but they should be clearly identified as opinions and supporting evidence should be provided. Anyone who has been an auditor for any time knows that it is sometimes necessary to report unpleasant findings. These results are often the most beneficial to the auditee, providing information that in-house personnel may be unwilling to present. When presented properly by an outside auditor, the “bad news” may act as the catalyst to long-needed improvement. However, the auditor is advised to expect such reactions as denial, anger, and frustration when the findings are initially received. In general, unpleasant findings should be supported more extensively. Take care in wording the findings so that the fewest possible emotional triggers are involved. The sooner the auditee and auditor can begin work on correcting the problems, the better for both parties. If a report is prepared by more than one person, one person will be designated as senior auditor. The senior auditor will be responsible for assembling and reviewing the completed report. If the audit was conducted by a second party, distribution of the report will be limited to designated personnel in the auditor and auditee’s organizations, usually senior management. If a third-party audit was conducted, the audit report will also be sent to the client, who in turn is responsible for informing the auditee’s senior management. In certain cases (e.g., government audits, financial audits), the results are also made available to the public. However, unless otherwise specified, audit reports are usually considered to be private, proprietary information that cannot be released without the express written permission of the auditee. Post-Audit Activities (Corrective Action, Verification) Audit reports often contain descriptions of problems and discrepancies encountered during the audit. However, not all problems are equal; some are more serious than others. A well-written audit report will classify the 10_Pyzdek_Ch10_p209-226.indd 220 11/16/12 4:55 PM Quality Audits 221 problems according to how serious they are. Product-defect-seriousness classification schemes are discussed below. Some organizations also apply seriousness classification to discrepancies found in planning, procedures, and other areas. These seriousness classifications (e.g., “critical,” “major,” “minor”) should be explicitly defined and understood by all parties. Generally, some sort of weighting scheme is used in conjunction with the classification scheme and an audit score is computed. Although the audit score contains information, it should not be the sole criterion for deciding whether or not the audit was passed or failed. Instead, consider the numerical data as additional input to assist in the decision-making process. Most audits are not pass/fail propositions. Rather, they represent an effort on the part of buyers and sellers to work together for the long term. When viewed in this light, it is easy to see that identifying a problem is just the first step. Solving the problem requires locating the root cause of the problem, which is challenging work. Many times the problem is treated as if it were a cause; that is, action is taken to “manage the problem” rather than addressing its cause. Exles of this are inspection to remove defects or testing software to catch bugs. Wilson et al. (1993) define “root cause” as that most basic reason for an undesirable condition or problem, which, if eliminated or corrected, would have prevented it from existing or occurring. Root causes are usually expressed in terms of specific or systematic factors. A root cause usually is expressed in terms of the least common organizational, personal, or activity denominator. In most cases the auditor is not capable of identifying the root cause of a problem. The auditee is expected to perform the necessary analysis and to specify the action taken to address the cause(s) of the problem. At this point the auditor can sometimes determine that the root cause has not been identified and can assist the auditee in pursuing the problem at a deeper level. At other times there is no choice but to validate the corrective action by additional audits, tests, or inspections. The final proof of the effectiveness of any corrective action must be in achieving the desired result. Product, Process, and Materials Control Work Instructions Work instructions must establish quantitative or qualitative means for determining that each operation has been done satisfactorily. These criteria must also be suitable for use with related inspections or tests, because work instructions serve operating personnel, supervisors, inspectors, managers, and even customers. Compliance with instructions is subject to review and audit. 10_Pyzdek_Ch10_p209-226.indd 221 11/16/12 4:55 PM 222 Process Control Work instructions include the documented procedures that define how production, installation, or servicing will take place. These instructions describe the operating environmental conditions as well as the activities necessary to ensure that the finished product meets all of the customer’s requirements. Work instructions also includes “cheat sheets,” “crib notes,” and other tidbits that people keep to remind them of the way “it’s really done.” ISO 9000 makes these informal notes part of the official documentation of the process. Just how far one should go in documenting a process is debatable. Clearly, if the documentation becomes so massive that no one has time to read it all, it no longer serves its purpose. Work instructions that include an overwhelming number of “tips” associated with rare problems over a period of years will make it more difficult to locate the truly useful information. Consider, for exle, your daily trip to work. Simple documentation might list the streets that you take under normal conditions. However, one day you find a traffic jam and take an alternate route. Should you write this down? Well, if the traffic jam is caused by a long-term construction project, perhaps. But if it’s due to a rare water-main rupture, it’s probably not necessary. General George Patton famously said, “Don’t tell people how to do things. Tell them what to do and let them surprise you with their results.” Allowing flexibility in work instructions, when workers are properly trained in their cross-functional purpose in satisfying customers, can provide empowerment and lead to superior customer service. In this context, work instructions can provide the reasons for satisfying particular objectives of the function (the why’s for the what’s), rather than the specific how’s, which may overly constrain discretion. As technology improves, databases may be developed to quickly and effectively filter information relevant to the task at hand. This will effectively increase the amount of data that can be made available to the process operator. Until then, the documentation must be contained within human cognitive limits. The guiding principle should be minimum size subject to being reasonably complete and accessible to those who will use it. Work instructions should cover the following items: • The manner in which the work will be done • The equipment needed to do the work • The working environment • Compliance with other procedures and documents • Process parameters to be monitored and how they will be monitored (e.g., checklists, control charts) 10_Pyzdek_Ch10_p209-226.indd 222 11/16/12 4:55 PM Quality Audits 223 • Product characteristics to be monitored and how they will be monitored • Workmanship criteria • Maintenance procedures • Verification methods (process qualification) Work instructions should be written in clear, simple terms, using the language that is easiest for the person doing the work to understand. The people doing the work should be intimately involved in preparing the work instructions. Pictures, diagrams, graphics, and illustrations should be used to make the documentation easy to understand and apply. If the instructions are voluminous, they should include such aids as indexes, tables of contents, tables of figures, tabs, etc. to assist in locating relevant information. Of course, to ensure that they are up-to-date, the documentation should be cross-indexed to the engineering drawings, purchase orders, or other documents that they implement. Work instructions should be part of the overall document control system of a firm. Classification of Characteristics All but the most simple products or services include large numbers of features or characteristics of interest to the customer. In theory, every feature of every unit produced, or every transaction conducted, could be inspected and judged against the requirements. This would add considerable cost to the product and, for most features, add little or no value to the customer. Instead, it is better to establish a hierarchy of importance for the various characteristics of the product or service. Which features are so important that they deserve a great deal of attention? Which need only a moderate amount of attention? Which need only a cursory inspection or review? The activity of arriving at this determination is known as classification of characteristics. In practice, characteristics are usually classified into the categories critical, major, and minor. The terms can be defined in simple terms as follows: Critical characteristic. Any feature whose failure can reasonably be expected to present a safety hazard either to the user of the product, or to anyone depending on the product functioning properly. For service, any characteristic that would lead to legal implications, or severely impact reputation. Major characteristic. Any feature, other than critical, whose failure would likely result in a reduction of the usability of the product. For service, any characteristic that would lead to loss of goodwill or future business. 10_Pyzdek_Ch10_p209-226.indd 223 11/16/12 4:55 PM 224 Process Control Minor characteristic. Any feature, other than major or critical, whose failure would likely be noticeable to the user. Incidental characteristic. Any feature other than critical, major, or minor. While it is possible to develop classification schemes that are more detailed, the above definitions suffice for the vast majority of applications. Identification of Materials and Status Has this been inspected? If so, was it accepted? Rejected? Does it require rework? Re-inspection? Retest? Obtaining clear answers to these ques tions is a primary task in quality control. Virtually all quality systems stan dards and specifications require that systems that identify the status of purchased materials, customer-supplied materials, production materials, work-in-process, and finished goods be developed, well documented, and fully implemented. Purchased Materials Proper identification of purchased materials begins, of course, with the supplier. A key part of the supplier’s quality system must include the identification of materials and status discussed below. Once received, the quality status of purchased materials should be identified in accordance with documented procedures. The procedures should cover how purchased material will be identified (e.g., with status tags), where the materials are to be stored until conformance to requirements has been established, how nonconforming material will be identified and stored, and how to process nonconforming purchased materials. Customer-Supplied Materials Procedures must be developed and documented for the control of verification, storage, and maintenance of customer-supplied product provided for incorporation into the supplies, or for related activities. The procedures must ensure that product that is lost, damaged, or otherwise unsuitable for use is recorded and reported to the customer. Work-in-Process (WIP) Procedures for the identification of the inspection and test status of all WIP should be developed and documented. The identification of inspection and test status should be part of the quality plan covering the entire cycle of production. The purpose of the procedures is to ensure that only product that has passed the necessary inspection and test operations is delivered. WIP procedures should also include any in-process observations, verifications, and tests that are required. For exle, some products must undergo certain interim processing that cannot be verified except by direct observation as the processing is taking place. 10_Pyzdek_Ch10_p209-226.indd 224 11/16/12 4:55 PM Quality Audits 225 Finished Goods The quality plan should include procedures that document the tests or inspections required prior to the release of product for delivery to the customer. The procedures should specify how the inspection and test status of finished goods will be shown, where the goods will be stored while awaiting shipment, and proper methods of packaging, handling, and loading the goods for final delivery. Lot Traceability Documented procedures should be prepared to ensure that, when required, lot traceability is maintained. Traceability is largely a matter of record-keeping. The system should ensure that the units in the lot and the lot itself are identified, and the integrity of the lot is maintained (i.e., every unit that is part of the lot remains in the lot). Lot traceability is generally required when there is reason to believe that the unit in question may need to be located at some time in the future. There are many reasons why this might be necessary, but the primary reason is that a safety defect might be discovered. The manufacturer should be able to quickly communicate with all those who are at risk from the defect. Items whose failure would cause an unsafe condition to exist are known as critical components or critical items. Materials Segregation Practices The previous sections describe various activities relating to the identifica tion of various types of materials, for exle, by type of defective, or by processing status. Once a “special” classification has been made (e.g., material to be scrapped or reworked), the procedure specifies how the affected material will be identified. Next, provision must often be made to physically remove the material from the normal processing stream. Formal, written procedures should be developed to describe the control, handling, and disposition of nonconforming materials to ensure that such materials are adequately identified and prevented from becoming mixed with acceptable materials. The physical control of nonconforming materials varies widely from firm to firm and by type of problem. Some organizations require that discrepant-critical components be immediately removed to a locked storage area and require authorization from designated individuals for release. Configuration Control Configuration control is the systematic evaluation, coordination, approval or disapproval, and implementation of all approved changes in the configuration of an item after formal establishment of its configuration identification. 10_Pyzdek_Ch10_p209-226.indd 225 11/16/12 4:55 PM 226 Process Control The intent of configuration management is to control the form, fit, and function of configuration items. Configuration control is primarily concerned with managing engineering changes. Deviations and Waivers While an engineering change involves a permanent change to the engineering design, a deviation is a temporary departure from an established requirement. Deviation requests should be formally evaluated and approved only when they result in significant benefit. Repeated deviations should be investigated; if the underlying requirements are too stringent, they should be modified. 10_Pyzdek_Ch10_p209-226.indd 226 11/16/12 4:55 PM
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