Introduction
Audit is an independent, systematic and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. One basic purpose of an audit is to ensure that cheating has not occurred within the company. (Busby,2011) There are three categories of audits can be carried out in the institution, which are first party audit as same as internal audit, second party audit and third-party audit. First party audit is carried out by the organization itself for management review or other internal purpose which known as internal audits. Furthermore, second party audit is conducted by parties having an interest in the organization, for instance, customers. In addition, third party audit is conducted by external, independent auditing organizations, for example, providing registration or certification of conformity to requirements of ISO9001. There are different types of audit can be applied within the corporation, which are quality system audit, management audit, process audit, procedural audit, system audit, product or service audit. This assessment will carry out an audit plan within the Quality Tool Inc.
Audit plan is the plan of auditing the entire process at periodic intervals so that it can evaluate the effectiveness of the control of process and review whether the process is in control or not.
Audit Plan
The aim of auditing is to determine the processes of a company to challenge the policy, regulations and objectives and report on the findings. In auditing there are three classifications of audits. Audits of first, second and third party. The first part audit is classified as an internal audit. This assessment will audit the company through an internal point of view. Their role is to help verify whether an organisation’s management system is operating reasonable. Furthermore, it can be used as the basis for the organisation’s self-declaration statement. In doing so, provides information to efficiently perform management reviews and corrective and preventive measures. The audit will be carried out on quarterly basis for the clauses. The audit will be carried out on any of the working day in the month as per the agreement between the process owner and the auditor. The auditor will send the request to the process owner and the process owner will confirm his availability. Based on the availability of the process owner, the auditor will complete the audit in the process.
Implementation for an internal audit
Internal auditing is the most influential implementation to shape, uphold and improve a company’s quality management system. This is because employees can realize the extensive part about the company.
Aim
The objective of the internal audit is to maintain and enhance the applicability and satisfaction of Quality Management System within Quality Tool Inc with the standard of ISO 9001:2015.
Meet requirements for certification to a management system standard
Verify conformance with contractual requirements
Obtain and maintain confidence in the capability of a supplier
Contribute to the improvement of the management system
Audit dates
Department
22 Feburary
23 Feburary
24 Feburary
25 Feburary
Materials/ Purchasing
X
X
Manufacturing
X
X
X
Quality Manage (QMS Management)
X
X
X
X
Sales& Marketing/ Customer service
X
X
X
Human resources/ public relations
X
X
Engineering& technical services
X
X
X
Production
X
X
X
Shipping, receiving & warehouse
X
X
Audit Team
The audit team has the designated role to collect key materials on gathering information through interviews, records, manuals, documents, data, and observing. Yihao Liang; the assigned leader for the audit team, along with Abbey Bannan, Brandon Wong, Harley Nguyen, Justin Ji and Sean Shan as auditors. During the production, the audit team will work extensively with other organisations to regulate final findings
Audit plan for QTI:
Clause 7 – Support
22 February 2016 will be the scheduled date for auditing Clause 7 – Support, which will start at 10 am.
7.1 Resources
Determine whether the company is providing the staff and processes which is needed for the efficient operation of the QMS to consistently meet the applicable statutory and regulatory requirements and clients.
Determine whether the company is providing and maintaining the infrastructure to ensure the consistency of services and products, which infrastructure can be identified as software, hardware, information and communication system and transportation. In addition, infrastructure must be maintained.
Determine whether the company is providing and maintain conditions needed for the operation of its processes for consistency of products and services. Furthermore, factors like social, psychological, physical, environmental and other factors can be the conditions for the operation of processes.
Ensure that the company is providing valid and reliable measuring and monitoring results to make sure products and services meet the requirement. Furthermore, the right fit for purpose equipment must be used in monitoring and measurements. In addition, the company need to ensure equipment of measurements are calibrated, and the instruments are identified and maintained to determine their calibration status.
7.2 Competence
Determine whether employee in the company have competence required for work which affects quality performance. Competence includes ensuring staff have appropriate education, experience or train for the position. In addition, employees have the ability to take action to get the necessary capacity and evaluating the effectiveness of the actions taken.
7.3 Awareness
Determine employees understand quality policy and objectives, advantages of improved quality performance, contribution to an effective Quality Management System, importance of satisfying need for customer, meeting customer requirements, and meeting statutory and regulatory requirements.
7.4 Communication
Determine whether the company has the approaches between internal and external communication of quality matters.
7.5 Documented Information
Determine whether the company has included documented information about ISO 9001:2015 in the QMS which is required for an effective QMS.
Determine whether the company has reviewed and approved documented information for adequacy and suitability.
Determine whether the company has secured and controlled documented information is available and suitable for use.
Audit evidence: customer feedback, contract, procedure,
Clause 8 – Operation
The scheduled date for auditing this part is 23 February 2016, furthermore, the scheduled start time is 10 am.
8.1 Operational planning and control
Determine demand for services and commodities of the company, furthermore, establish standards for the acceptance and processes of commodities and services
Determine whether the company has the needed resources to fulfil the requirements for commodities and services, moreover, using established criteria to control the processes. Furthermore, ensuring company has kept documented information to make sure processes have been conducted as planned and meet the requirements.
8.2 Requirements for products and services
Determine whether the company has created ways for communicating with clients in feedback and perceptions from them, processing or handling of their property, information relate to services and products, order handling, enquiries and contracts and specific requirements for emergency reactions.
Determine whether the company has defined regulatory and applicable statutory requirements, in addition, it can substantiate the claims for the services and commodities and defined requirements it offers.
Determine whether the company has reviewed requirements for related services and commodities assigned by customers and company, furthermore, additional statutory and regulatory requests and order or contract conditions.
8.3 Design and development of products and services
Determine whether the company build, enforcement and maintenance a development process and design to make sure supply of services and products.
Determine whether the company consider about authorities and responsibilities of design team, control of interfaces between clients and individuals, nature, complexity, duration, external and internal resources needed, requests in specify process stages, required verification and validation, necessary documented approvals and information within a design plan.
Determine whether the design team of company has retained documented information on design inputs, which includes applicable regulatory and statutory requirements, potential outcomes of failure due to the properties of services and products and essential performance and capabilities requirements.
Determine whether the design and development process are controlled to make sure that goals are achievable and clearly defined, actions are taken on problems identified, reviews are conduct as planned to evaluate outcome and documented materials on control are kept.
8.4 Control of externally provided products, processes and services
Ensure whether the company externally provided products, processes and services that meet the requirements
8.5 Production and service provision
Determine whether the company has implemented controlled conditions, for instance, availability of documented information that defines the outcomes to be obtained and activities to be executed, features of the services and commodities, use and control of suitable process and facilities environment, use and provision of appropriate measuring and monitoring resources for the provision of production and service.
Identify whether the company respect to measurement and monitoring rules throughout provision of service and production.
Determine whether the post-delivery activities such as maintenance services, final disposal and recycling of company are required with consideration of potential undesired results associated with the services and productions, customer feedback, regulatory and statutory requirements.
8.6 Release of services and products
Determine whether the company has maintained records to provide proof that services and commodities have passed final test or examination, furthermore, documented information must be provided, which is traceable to the person for present to the customers.
8.7 Control of nonconforming outputs
Ensure whether the company has controlled and determined nonconforming products and services to prevent unexpected delivery or use for customers, in addition, determine corrective actions based on the properties of the nonconformity and its impact on the services and commodities.
Identify whether the company has corrective actions after nonconforming products are detected after delivering to customers, for instance, informing customers immediately, obtaining authority to accept under concession. In addition, inspection is required for all corrected products by the procedure to verify and demonstrate conformity to requirements.
Clause 9 – Performance evaluation
Scheduled date for this section of auditing is 24 February 2016, with the start time of auditing at
10 am.
9.1 Measurement, monitoring, evaluation and analysis
Determine whether the company has approaches for reviewing, obtaining and monitoring information from customers about how well their expectations and needs are met.
Determine whether the company has evaluated and analysed information and figures collecting from measurement and monitoring activities from customers.
Determine whether the company has evaluated how the efficiency of taking actions to address opportunities and risks.
9.2 Internal audit
Determine whether the company has implemented and maintained the QMS effectively, furthermore, make sure QMS meets the requirements of standard of the company and ISO, and conduct internal audits at planned intervals.
Identify whether the company has planned and carried out audits in an impersonal and impartiality manner within a system.
Determine whether the company has kept documented information about internal audits.
9.3 Management review
Determine whether the top management of company review the QMS at planned intervals to make sure it keeps effective, adequate, suitable and correct strategic direction with the company.
Identify whether the reviews consider specific inputs, for instance, opportunities for enhancement and status of former review.
Determine whether outputs of review include actions and decisions relevant to resources required, chance for improvement and alteration to the QMS.
Audit both evaluation and analysis documentation based on the aspects of monitoring, measuring and investigation of customer satisfaction. Furthermore, determine the findings are to be reasonable and effective, in order to be utilized as improvements in the future. The following below should be followed:
Circumstances of top management must thoroughly be investigated. The company’s quality management system must be reviewed.
Important documented information must be audited, as well as locate updated information.
Clause 10 – Improvement
The scheduled date for this section of auditing is 25 February 2016 and the expected start time of auditing will be 10 am.
10.1 General
Determine whether the company take into consideration of improving services and commodities to meet the requirements and to address subsequent expectations and needs, in addition, reducing, correcting and preventing undesired effects, and enhancing performance of quality management system performance.
10.2 Nonconformity and corrective action
Determine whether the company has made sure that non-conformances are solved when it occurs, and corrective actions are adopted immediately to control and correct it, in addition, the actions must be suitable to the impact of the non-conformances.
Determine whether the company has retained documented information about the properties of nonconformities, results of corrective actions and future actions taken.
10.3 Continual improvement
Determine whether the company has continually improved adequacy, applicability and efficiency of the QMS.
Determine whether the company has identified areas that is under performance or opportunities that must be addressed as part of sustained improvement by considering the findings of evaluation and analysis and outcomes from management review.
Audit the company eccentricity and how they can re-evaluate by implement measures to correct errors and prevent reoccurrences.
Investigate the company’s quality management system. This includes competence, suitability, effectiveness and how they will reconcile.
Audit appropriate documented information and updated information.
Opening Meeting Agenda
Introductions
Leader of the audit team will introduce and opening meeting.
Attendee sign-in
Sign on to the Internal Audit Plan and save in the audit file as documented attendance information.
Review the scope of the audit
Define the importance and plan of this internal audit
Establish communication
Allocate roles for each auditor
Confirm times
Regulate changes to the scheduled audit time
Schedule the closing meeting
Confirm the time and place for the closing meeting.
Ask for any questions
Internal Audit Plan
Audit number: 1
Opening meeting attendees: A Doer, R Ryan, D Delany, D Thomas, M T Moore, J Sample, A Bolt, R Richards, A Anderson, R Roberts
Scheduled date: 20th Feburary 2018
Areas to be audited: Top management, Manufacturing, Sales and Marketing, Materials and Purchasing, QMS Management
Closing meeting: As above
Scope of audit and objective: Scope will consist of auditing the quality management system in relation to Clauses: 7, 8, 9 and 10
Standard: ISO 9001: 2015
Lead auditor: Yihao Liang
Auditors:Abbey Bannan, Brandon Wong,
Harley Nguyen, Justin Ji and Sean Shan
Proposed Schedule
Time
Procedure
Team 1
Team 2
20.2
Opening meeting
21.2
Auditors and review documents meeting
22.2
Clause 7: Support
23.2
Clause 8: Operation
24.2
Clause 9: Performance evaluation
25.2
Clause 10: Improvement
25.2
Auditors and review finding meeting
26.2
Final meeting
Corrective actions to be verified: This is the 1st internal audit at QTI, therefore none.
Primary contact: J Sample
Time and Place for final meeting: 4:30 PM in conference room 1.
Signature of Lead Auditor:
Date: 20th Feburary, 2018
References
Busby, L. (2011). The Audit. The Serials Librarian, 61(3-4), 311–320. https://doi.org/10.1080/0361526X.2011.617293
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