Quality Manual 

The quality manual is an apex QMS document which fully describes & covers the quality management system of an organization. It is key to the process, serving as a guide for the entire system. The manual will clearly lay out the quality policies, procedures, guidelines, forms & templates. 

As per ASQ, (https://asq.org/quality-resources/iso-9001-quality-manual): 

Organization of Quality Manual, There is no requirement that the quality manual mirror the conformance standard. If the QM is used to demonstrate conformance to a number of requirements, it is impossible to do in a single QM. The manual should be organized in a way that is suitable for your organization, because your people are the ones using it every day. A simple matrix can be used to reference parts of the QM to requirements in the conformance standards. 

Scope of Quality Manual, If the entire organization operates under the defined quality management system (QMS), then there is little need to specifically define the scope. If the QMS applies to only part of an organization, then the scope must be explicitly stated. 

Size of Quality Manual, Ever since ISO was released, there has been much discussion on how big or small the QM should be. Realistically, it should be the size that is “just right” for your organization. Do not try to force it into an arbitrary (small) number of pages, but do not be overly verbose, either. The QM should be a top-level overview of how the organization operates and does business. Policies, procedures, work instructions, proprietary information and the like belong in separate documents. While the QM must be reviewed regularly, if a clause or section is changed every time then that part may be a candidate to be pulled out to a separate document. When deciding what goes into the QM, remember the two main phases of an audit. First, your QM is evaluated against the conformance standard(s) to make sure all requirements are addressed satisfactorily. Then, your organization's operations and records are evaluated against your QM to verify that you are doing what you say you are doing. In the second phase, anything in your QM is fair game for the auditor to look at.

Why Documentation (Source: https://darpg.gov.in/sites/default/files/Training_Manual.pdf) 

Quality Management System of an organization is required to be a Formal System. 

A documented system is expected to help in fulfilling the requirements of such a system, which are : 

• Need for system dependent organization (not a person dependent one). 

• Documented system provides evidence of Management Commitment to Quality based practices. 

• Practices demonstrating competence of the organization to achieve objectives. 

Further a documented system: 

• Enables communication of intent. 

• Ensures consistency of action. 

• Is a source for responsibility and authority. 

Types of Documents 

The arrangement of Quality Management System documentation typically follows either the processes of the organization or the structure of the applicable quality standard, or a combination of both. Any other arrangement that satisfies the organization’s needs may also be used. The structure of the documentation used in the quality management system may be described as a hierarchy. This structure facilitates the distribution, maintenance and understanding of the documentation. 

Quality Procedures 

These are documents that provide information about how to perform activities and operations consistently, at a system/ administrative level. It is an operating level document for carrying out any management activity. The structure and format of the documented procedures (hard copy or electronic media) should be defined by the organization in the following ways: text, flow charts, tables, a combination of the above, or any other suitable method in accordance with the needs of the organization. 

The documented procedures should contain the necessary information) and should contain a unique identification. Documented procedures may make reference to work instructions that define how an activity is performed. Documented procedures generally describe activities that cross different functions, while work instructions generally apply to tasks within one function. 

Work instructions/ Standard Operating Procedures 

Documents that provide detailed information about how to perform activities and operations consistently at operational level. 

Forms 

Forms are developed and maintained to record the data demonstrating compliance to the requirements of the quality management system. Forms should contain a title, identification number, revision level and date of revision. Forms should be referenced in, or attached to, the quality manual, documented procedures and/or work instructions. Forms generally become records when filled. 

Other Documents that could be in use or developed as a part of the QMS are 

• Standard Operating Procedures (SOPs) 

• Specifications; 

• Office manuals 

• Documents like Quality plans, charts, text books, software, drawings, memos & notices, etc; 

• External documents e.g. Législative Documents, Rules, Instructions issued by Statutory authority from time to time 

• Records. 

Internal Audits 

Internal Audit requires an organization to look into its own system, procedures and activities in order to ascertain  (https://darpg.gov.in/sites/default/files/Training_Manual.pdf) : 

• whether they are adequate and are being complied with. 

• whether the system is as efficient and effective as it should be, and 

• whether changes are needed. 

It is a management tool to gain insight in to performance levels of all functional areas.  To discover actual and potential weak areas.  It helps in establishing internal bench marks for improvements.  

An internal audit can help in promoting interchange of good practices among  various functions and department. By rotating the auditing personnel in successive audits, the organization can provide to its personnel a better appreciation of other work areas, thereby improving decision making. 

Existence of an internal audit system, prevents casual approach to work and often provides a challenge to prove efficiency. 

Internal Audit Objectives 

• Assessing the compliance or conformance with respect to intents and/or specified requirements. 

• Assessing the compliance and effectiveness of established system. 

• Assessing opportunities for improvement in the existing Quality Management System. 

• Evaluation of suppliers competence in fulfilling contract requirements. 

• Assessing compliance to regulatory requirements 

Internal Audit Planning 

Audits are planned and managed to ensure that they are conducted in an effective and consistent manner and that the audit conclusions are credible. (Source: https://darpg.gov.in/sites/default/files/Training_Manual.pdf) 

Audits are conducted using established methods and techniques to ensure that audit evidence and audit findings are relevant, reliable and sufficient to yield consistent audit conclusions. 

Some basic plan must be drawn to decide the various activities and aspects that need be audited. 

These include internal functions performed by various groups within the department and also the external functions performed by the subcontractors, suppliers, or other outside groups. Based on the importance and criticality of the functions and activities the frequency may be decided/varied within the overall frequency stipulated for the entire audit program. The plan can be drawn up in the form of matrix that shows all groups/functions/activities required to be audited along one axis and the planned and executed audits on the other axis. Depending on the criticality of the function/activity higher frequency can be planned by repeating the same. Similar plan can be made for external audits. 

Scheduling of Audits 

Based on the overall plan, an annual audit schedule should be developed. 

The audit schedule should take in to consideration the following factors : 

• Resources available. 

• Criticality and importance of the activity. 

• Proper timing for auditing various activities – audit should be scheduled at times when the activities can be observed, rather than be limited to auditing just records. 

• More frequent audits may be desirable in areas with known problems or where large number of complaints have been received. 

• The audit schedule should have certain amount of flexibility built in to it to be able to be modified in view of new information received, changes in nature of activity, special management requests, etc. 

The prepared audit schedule should be distributed to all concerned. 

A detailed audit planning schedule may then be prepared, say on a quarterly basis giving information regarding ; 

• Activity to be audited. 

• Audit dates. 

• Audit team leader and members. 

It is important that all affected managers of the audited group receive a copy of this schedule, including the external parties if they are included in the audit schedule. There are suggested nine steps that are useful in helping prepare for an audit. These are: 

• Define the Purpose of the audit. 

• Define the scope of the audit. 

• Determine the resources to be applied. 

• Identify authority for the audit. 

• Identify the performance standards to be used. 

• Contact the audited. 

• Develop written checklist. 

• Review performance history of the audited. 

• Develop the initial understanding of the control systems. 

While each audit is likely to be different from the others, these steps are common to all types of audits that may be performed. Hence an auditor can design and create his/her own checklist for preparation phase in order to ensure that all the steps are covered. The next step is to establish the scope of the audit. The scope establishes the limits and boundaries of the audit and identifies the items, groups and activities to be examined. Defining the scope also helps in making the most efficient use of the audit resources – manpower as well as time resources. The scope of an audit will vary considerably. Typically in an internal audit scenario, it is better for audit managers to breakdown the entire task in to smaller segments while planning the audit so that time availability of both the auditor and the audited departments can be planned and utilized effectively and optimally. 

The scope of an audit has a great deal of effect on its length. If the scope is too large, it will be difficult to complete the audit in a reasonable time. Conversely too narrow a scope will waste valuable resources. In view of this, time resources of both auditors and audited and personnel availability should be kept in mind at audit planning itself and subsequently while deciding the audit scope. It should be properly balanced with the depth and extent requirement of the audit. Keeping track of the audit scope, may be one of the more challenging tasks for the audit team and particularly the team leader. Often during the course of the audit additional areas in need of examination appear which may be outside the original scope of the audit. It must be decided at this point, whether the concern is important enough to be pursued immediately or it can wait separate examination at a later date. In order for the audit to be effective and successful the audit team members must be trained and should be aware of the rules and procedures and also must be knowledgeable of the processes to be audited. 

Audit Checklist 

A list of items to be examined / verified during the audit, prepared after examination of all audit criteria and documents is termed as audit checklist. This checklist serves as a guide to each member of the audit team, in order to assure that the full scope of the audit is adequately covered. 

Conducting the Internal Audit using Checklist

An internal audit is less formal than an external audit, yet it mist be conducted in a professional manner without prejudices or biases that an internal auditor may carry owing to his knowledge and experience. It is a fact finding activity and the results have to be generated, both for positive as well as negative compliances based on objective evidence alone. Before conducting an internal audit, the auditor (s) must ensure that the audited has been informed of the audit scope, date, time etc and that he (the principal) audited is actually available for audit. The requirement for conducting a formal opening meeting is essential in an external audit, but optional for internal audits. If opening meeting is conducted, the auditor must inform the purpose, scope, process and duration of the audit and agree on the status of the reference documents. Internal audits shall involve the examination of availability and understanding of documents, such as manuals, procedures, etc, the examination of records to establish compliance levels, the examination of analysed data to see that measurements are taking place as intended and being used for tends analysis, the physical setting and environment where service delivery is taking place, the organization of responsibilities and duties within the department, effectiveness of information flow and channels of communications and interview with personnel within the audit scope to establish that they are aware of their responsibilities, and their contributions in meeting quality objectives. All audits are based on samples, as it is impossible to examine all the documents, records and personnel on cent per cent basis. The selection of the right sample is therefore very critical in an audit. 

Audit Findings and Observations 

Audit findings are the results of evaluation of collected audit evidence against the audit criteria and can indicate either conformity or non-conformity with audit criteria or opportunities for improvement. Generally speaking, the unsatisfactory conclusions are termed as findings/ non-conformities and opportunities for improvements as observations. In any case findings/non-conformities are generally, something that can lead to, or has resulted in a condition adverse to quality and needs to be corrected immediately. An observation is a detected system weakness which, although not a non-conformity, if not corrected, will in time result in degradation of product or service quality. In internal audit scenario observations assume great significance since they can become definite vehicles for improvement. 

Non-Conformities (Non-Conformances)

In audit parlance a non-fulfilment of a requirement is termed as a non –conformity. Non-conformity can be classified as major or minor. 

A major non-conformity is: 

• Absence of a procedure required by standard. 

• Significant failure to implement a procedure. 

• Direct-effect on quality of results. 

All other non-conformities are minors. 

During the audit where auditor finds no evidence of discrepancies they should proceed quickly. If there are problems auditors must examine the evidence to the depth necessary to gain objective evidence. 

Corrective Action 

The official definition of this term is – “Corrective Action is the action to eliminate the cause of detected nonconformity or other undesirable situation.” 

There could be more than one cause for nonconformity.  Corrective action is the action taken to prevent reoccurrence, as opposed to preventive action which is taken to prevent occurrence. Further there is a distinct difference between corrective action and correction, which is the action to eliminate detected non-conformity. The basic principle of corrective action is that, as a first step the conditions adverse to quality must be promptly identified and corrected. The next step is to do a root cause analysis to identify the reasons for its occurrence in the first place and then take actions to prevent its repetition. This later portion of the corrective action process is most difficult to implement. The true causes of problems are difficult to identify. 

Any corrective action program has three fundamental components : 

• To find the problems. 

• To fix the problems (Correction). 

• To correct the causes of problems (Corrective action). 

The audit program along with other forms of monitoring like inspection and surveillance addresses only the first step – Finding problems 

When addressing the solutions to problems/non-conformities, it is important that immediate correction of the specific reported deficiency, not be confused with action taken to correct the cause of the problem and prevent its recurrence. The action of corrective action program is to analyze and remove these impediments to quality, safety, reliability, productivity, etc. It must be a serious and continuous process. 

In most cases when a deficiency / non-conformity is pointed out, immediate action is taken to correct the same, however it may take some time for the audited to complete the root cause analysis for the problem occurred, identify the action required to be taken to prevent recurrence of such problem in future, which may in fact take some more time. The reporting for the internal audit program could allow for the same. 

Audit Report 

The final Product of any auditing activity is the audit report. Hence for the auditing activity to be credible and successful it is essential that audit report has certain characteristics, which are: 

Verifiability 

The audit report should be verifiable. By giving appropriate references to specific items, records, persons, locations, activity, etc an element of verifiability can be built in to the report. 

One of the main purposes of the structured checklists is to record verification information. The completed checklist should be kept in file as backup. Simple, clear and direct language of the report can also reinforce the element of verifiability of the report. 

Inferences 

An inference is a statement about the unknown made on the basis of the known. For example, one may infer say lack of control over purchase activity from the number of rejections of the received material on receipt. The technique of gathering and analyzing facts allows for presentation of the inferences in an understandable and logical fashion, so that any reasonable person, presented with the same facts will draw similar conclusions. However one must keep in mind that most people would need more convincing (stronger facts and more of them) if the inference does not support a previously held conviction. 

Judgments 

Judgments are expressions of approval or disapproval. Like inferences, they can not be avoided. Hence an auditor must be aware of the judgments used in the report. The most important part of the entire report, the summary section is basically one big judgment. While making a judgment it is very essential that they must be made very clear and understandable and by providing adequate evidence as gathered during the audit. This is especially true if the judgments are of adverse nature from the receivers’ point of view. The Internal Audit report shall include all the non conformities determined and the corrective actions proposed by the audited together with an indication of the time frame for taking the corrective actions. In internal audits, it is also a good practice to report positive compliances based on the checklist and auditors suggestions for improvements. The Report is submitted to the audit manager, who reviews it and takes further actions for closing out the internal audit. 

Response to the Audit Report 

After the audit report is issued, a response is required from the audited, if any nonconformities, findings or observations are presented. 30 to 45 days from receipt of audit report is typically the turnaround time for this response. Although for some of the nonconformities, depending upon the magnitude of gap, especially if they are document adequacy based, the correction and the corrective action may be same – modifications in Quality manual, procedure and/or work instructions. However in many cases the audited responsible for the relevant area may require time to think over all the aspects of changes required to be made, the repercussions of changes on other aspects of the management system, etc, before finalizing the changes. 

Follow-Up Audit Activities and Audit Close Out Actions 

Once the response has been analyzed and found acceptable, the promised corrective action needs to be verified in some fashion before the non-conformity can be closed. 

The options available for this are : 

• The response adequately describes the conditions of change and there appears a reasonable chance of success, than the same may be accepted and nonconformity may be closed immediately. 

• If, some proposed corrective action involves new or revised documents, the same could be forwarded to the auditors and based on the documentary evidence of satisfactory corrective action the same may be closed. 

• In certain cases merely a promise and subsequent production of documentary evidence of corrective actions by the audited, may not be considered adequate to determine the effectiveness of the corrective action in mitigating the problem. In such cases a follow up visit will be required to verify the implementation and effectiveness of the corrective action. This visit is generally restricted to verification only and does not call for looking in to the entire system or new audit areas, and is best done by the auditor(s) who had carried out the earlier audit. 

In actual practice closeout action for the audit may be a combination of all the three options as stated above. For some of the Nonconformities, even though they are closed based on objective actions, it may be desirable to verify subsequent continued compliance. This can be done by keeping appropriate notes for the auditors during subsequent audits, by the audit manager. 

Keeping track of the corrective action required to be taken within the agreed time frame, arranging for verification of its adequacy (taking the help of team leader/auditor) is the responsibility of the audit manager of the auditing organization. 

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