ISO 9001-2015: Compliance Audit of Quality Control Product Procedures

ABSTRACT


INTRODUCTION
Standard operating procedures are a reference for employees in carrying out performance processes. This can result in reliable manpower and awareness of compliance with procedures. Therefore, the importance of employee compliance in carrying out performance according to procedures has a major influence on the development of the company. To control and supervise compliance with procedures, companies must have a compliance management system such as Quality Control management so that they know whether their employees meet the standards in the procedures or not (Taufiq, 2019).
TEC Indonesia Corporation is engaged in electronic manufacturing and has long used ISO 9001:2015. Based on observations in the field, there are company discrepancies sourced from the quality control department. Quality control should be the heart of the company because it guarantees product quality. On observation, there is a problem or damage to the product caused by material part picking errors and improper processes in product work.
Based on the fishbone analysis, the root of the problem that occurs in the Quality Control Product Section can be seen from the fact that employees do not carry out the process correctly due to negligence and a lack of thoroughness in performance steps. In terms of measurement, the inspection carried out still uses the manual method, namely supervision that is carried out periodically by supervisors in a department. In terms of method, the instruction still uses paper form and is often updated regularly if there are additions or subtractions and verbal notification of changes. Meanwhile, in terms of material, there are often problem parts exceeding the quantity and placement of adjacent parts, which can cause incorrect parts to be taken by the operator.

Audit and Compliance Audit
According to Taufiqiyah (2022), an audit is the collection and evaluation of evidence regarding information in order to determine and report the degree of conformity between the information and the stipulated provisions. This is intended to find fault or cheating, although in its application it is very permissible to have mistaken or fraud. According to Sukrisno (2018), auditing is an examination that is done critically and systematically, by an independent party of the industry financial statements that have been prepared by management, bookkeeping records, and other supporting evidence with the aim of sharing input on the reasonableness of the company's report.
According to Irianto (2021), a compliance audit is the implementation of a work program to determine whether the audited party has carried out its activities according to established procedures. According to Syamsuri dkk (2021), a compliance audit is an audit that determines whether an entity being audited has complied with established regulations and policies. Based on some of the understandings above, it can be concluded that a compliance audit is an assessment of whether the scope of the company, both employees and management, has complied with procedures and regulations, or regulations made for decision-making against deviations.

Standard Operating Procedures and Internal Control Questionnaire (ICQ)
According to Ajusta dan Addin (2018), Standard Operating Procedures are important documents needed by companies to carry out operations according to established procedures. A standard operating procedure is a system of regulations or procedures in a company or organization so that it can run in a structured manner. Without procedures, a company will experience difficulties in running an operational system and tend to be inefficient in the process of improving its business performance (Putra & Surianto, 2021).
Internal Control Questionnaires are a process of actions and activities carried out repeatedly by both management and employees to provide confidence in the achievement of organizational goals through effective and efficient activities (Fikri et al., 2015). An internal control questionnaire is a questionnaire made to determine the level of compliance with the company's internal controls (Kurniato, 2018).

Working Papers and Audit Programs
According to Effendi & Mayasari (2019), A working paper is a series of documents related to client records and reports; therefore, working papers are an important component in auditing. The content of the paper itself must be able to prove and provide an explanation of the suitability of records, financial statements, and other information carried out by the auditor (Lubis & Dewi, 2020). According to Lusiana dkk (2016), The definition of an audit program is a detailed list of procedures for audits to be carried out in the audit process. The audit program was created because it is an important part of audit planning.

ISO 9001:2015 Certification
ISO 9001:2015 certification is an international standard for Quality Management System Certification. The purpose of this certification is to ensure that the products or services produced by an industry meet the requirements established by the world standard, namely ISO. If the industry has obtained ISO 9001:2015, then it has met the requirements internationally. It is said to meet the conditions where the industry is responsible for the quality assurance of the materials produced. International Quality Management System Certification is sourced from ISO 9001:2015 Certification, which is based on the principles of Quality Management System Certification. This principle's application is based on the experience and knowledge of international experts who participated in the ISO/TC 176 method committee. The committee has the responsibility to improve the ISO 9001:2015 Certification standard. The principles of quality management that are the basis for structuring ISO 9001:2015 certification include the following: 1. First, focusing on customers means attaching importance to customer satisfaction in terms of needs and expectations. 2. Second, Leadership: Leaders in the company are able to take responsibility for the goals set by the industry. To achieve the goal, it is mandatory to carry out the entity effectively. 3. Third, Involvement of Others: All levels in the industry are empowered and well engaged. 4. Fourth, Business Process Approach, a quality management system that is based on processes in the industry by linking all parties involved. 5. Fifth, Quality Improvement: An industry that survives and is able to compete is one that always carries out improvements. 6. Sixth, The Factual Approach to decision-making is to make decisions based on existing information and reality. 7. Seventh, A mutually beneficial bond Managing good ties between parties in the industry such as suppliers, employees, business partners, and others to maintain the industry's success and be able to compete.

Quality Control Product
According to Elmas (2017), Quality control is the action or management of the company to maintain product quality according to company standards. Control activities and maintenance of product quality in a company can obtain products of good quality so as to achieve consumer satisfaction. Quality control itself has an important role, namely as a form of strategic steps to ensure deviations can be detected so that they become evaluation material for product improvement in the future (Al Choir, 2018)

RESEARCH METHOD
This research was conducted at TEC Indonesia in the quality control product section, procedures documents, and ISO 9000:2015. This study used primary and secondary data. Primary data were obtained from direct interviews with line supervisors in the company. Meanwhile, secondary data from documents such as Company SOPs, ISO 9001:2015, and several relevant research articles. The population in this study was TEC Indonesia, while the research sample was in the quality control product section. The data collection methods used are: 1. Interview techniques Researchers conducted interviews with company line supervisors using the Internal Control Questionnaire (ICQ) related to procedure documents and ISO 9001:2015; 2. Documentation Techniques Researchers evaluate and analyze related documents such as procedures, quality products, and ISO 9001:2015; 3. Direct observation or observation Researchers observe directly at the location of the research site, namely, the performance of the process from the initial stage of product assembly to becoming a finished product; 4. Document Inspection Researchers inspect the procedures quality control product document analyzed based on SOP ISO 9001:2015. In analyzing the data, this study uses a qualitative descriptive method that explains the conditions that occur in the field. To get the results of the analysis, the steps that must be taken by the researcher are; Retrieving SOPs data for quality control products; Retrieving documents in the form of ISO 9001:2015; Develop an Internal Control Questionnaire (ICQ) and conduct in-person interviews; Processing ICQ data results; Conducting control tests and picking tests; Provide conclusions on the research and audit results of compliance with ISO 9001:2015 at TEC Indonesia; Provide advice and recommendations on the audit results.

RESULT AND DISCUSSION Internal Control Questionnaire (ICQ)
The author has made an internal control questionnaire based on ISO 9001:2015 in the quality control product section at TEC Indonesia Corporation, which is adopted from questions in the study Adhisty et al. (2021). The internal control questionnaire created aims to determine the level of conformity of SOPs with ISO 9001:2015, especially in the quality control product section. The author provides 14 questions for company respondents to answer with "yes" or "no". The calculation variables for the ICQ results are as follows: Then the ICQ results and calculations are processed to find the percentage results of their suitability, referring to Tampubolon & Riadi (2021).  Table  Percentage Information 0%-25% Non-compliant 25%-50% Not quite right 50%-75% Quite appropriate 75%-100% Appropriate (Source: Tampubolon & Riadi, 2021) Based on the ICQ results in tables 2 and 3, where there are 14 questions with thirteen "yes" answers and one question with a "no" answer, a percentage of 92.8% was obtained. With this, it can be concluded that TEC Indonesia, in carrying out SOPs based on ISO 9001:2015, has a good level of complince so that it runs as it should. In this ICQ, there are two scopes of discussion regarding control and corrective actions against non-conforming products. Here's for ICQ:

Control Test
In the control test, uses indicators from the internal control questionnaire (ICQ). The following is a list of procedures that have been made by the author: Check, Has the company established control procedures, persons in charge, and authorities for non-conforming products?
3. Check, whether the company has established appropriate treatment of non-conforming products by using one or more of the following means: a.
Taking action to eliminate the cause of the discrepancy found? b. Allow the use, release, or acceptance through concessions by relevant parties and where possible by customers? c.
Take precautions for use or intended initial application?

4.
Check Whether the original record of discrepancies, the various actions taken, including the agreements obtained, have been properly maintained? 5.
Check Whether the company has re-verified to show compliance with the requirements, if the nonconforming product is repaired? 6.
Check Whether the company has taken appropriate action on the potential effect of this discrepancy, when the product is not suitable, detected after distribution and use? (Source: Data processed by researchers, 2022) Check whether the company has taken sufficient action to reduce the cause of the discrepancy in order to prevent the recurrence of the matter? 2.
Check whether the corrective actions taken are in accordance with the cause of the discrepancy found? 3.
Check whether the company has established a written procedure for: a. Reviewing discrepancies (including customer complaints)? b. Determining the cause of the discrepancy? c.
Evaluating the actions needed to ensure discrepancies are not repeated? d. Determine and implement the required actions?

Procedures of Picking Test for Control of Non-Compliant Products
In carrying out procedures for the control of Inappropriate Products, the company uses Tracking Sheet documents, Operational Standards, Inappropriate Product Report history, and Engineering Tentative instructions.

Document Test of Picking Tracking Sheet
This document is for testing SOPs 1 and 2 and SOPs 3a as per Table 6. Here's a working paper that researchers analysed: Based on table 6 above, the results of the picking test using the Tracking Sheet for SOP sections 1, 2, and 3a are in accordance with the company's SOP, where the document is used for indications of products that are not suitable and need repair or handling of product repair parts. The document has been filled out accordingly. For the SOP 3b sample, the researchers did not find the documents used. The results of the study can be described below: Based on the conclusions obtained by the researchers in the SOP 3b picking test according to Table 7, the researchers did not find documents regarding the SOP in the company as stated in the ICQ. In this case, the respondent answered "Yes" in the ICQ, while in the actual field there were no activities or documents regarding the SOP.

Operational Standard Document Picking Test
This sample document is to test SOP 3c, namely Carrying out precautions for use or intended initial application. Here's a working paper that researchers analysed: In that part of the document has been designed and implemented in the field properly as it should be descriptions in the form of work instructions to ensure that the work process steps carried out are in accordance with the existing procedures in the company. In the study using the working paper above, it was concluded that the quality control department had filled in as it should.

Test Picking History of Inappropriate Product Reports
This sample document to test SOP 4, the original record of nonconformity, the various actions taken, including the agreements obtained, have been well maintained. Here's a working paper that researchers analysed: The picking test uses a product history report that is not suitable for SOP 4, where in the document there are reports of products that are not suitable within the period of 2022. Historical Report is a document reported by the quality control product department which is used as reporting on inappropriate products which is then approved by the TSE quality control section in the company. Regarding the documents above, they have been filled in properly and correctly by the department of quality control products by fulfilling existing procedures.

Picking test of Engineering Tentative Instruction
This sample is to test SOP 6, where the company has taken appropriate action on the potential effects of this nonconformity, when non-conforming products are detected after distribution and use. Here's the sample that the researchers analysed: Picking test using Engineering Tentative Instruction for Parts and SOP 6, where the document states the description of control instructions and repair instructions for products is not appropriate. The document has been filled out and implemented in the field properly according to company procedures.

Picking Test of Repair Procedures for Non-Compliant Products
In carrying out SOPs for Repairing Non-Compliant Products, the company uses Visual Inspection Instruction, Engineering Tentative Instruction, Quality Data Tracking documents.

Picking Test of Visual Inspection Instruction Document
The sample of this document used to test SOP 1 is that the company has taken sufficient action to reduce the cause of the discrepancy in order to prevent the recurrence of the matter. The picking test uses Visual Inspection Instruction for SOP 1 corrective action, where the document is a reference and inspection work instruction for inspector employees. Regarding the document, it has been appropriate, and the implementation has gone well.

Picking Test of Engineering Tentative Instruction
This sample document is used to test the SOP of corrective actions taken in accordance with the cause of the discrepancy found, determine the cause of the discrepancy, determine and apply the require action. Here's a working paper that researchers analysed: Picking test using Engineering Tentative instructions for parts and SOPs for repairs 2, 3b, and 3d, where in the document it is stated that the description of control instructions and repair instructions for products are not appropriate. The document has been filled out and implemented in the field properly according to company procedures.
Then for the SOP improvement in point 3a, namely a review of discrepancies including customer complaints, researchers did not find documents regarding the SOP following the explanation below:  Based on the conclusions obtained by the researcher in the SOPs 3a picking test according to Table 12, the researchers did not find any documents regarding the SOPs in the company as stated in the ICQ. In this case, the respondent answered "Yes" in the ICQ, while in the actual field there were no activities or documents regarding the SOPs.

Picking Test of Quality Data Tracking
This sample document is used to test SOPs, namely evaluating the actions needed to ensure discrepancies are not repeated. Picking test using Quality Data Tracking for SOP 4, where the document is a history of control documents on products that are not filled out and reported properly. Based on the results of the compliance audit that the researcher conducted as well as the results of observations and interviews conducted by the authors, here are some of the problems found: 1. In accordance with the SOPs for picking tests and product control that are not in accordance with the company, the company has carried out the SOPs and implementation correctly. However, for sop 3b enforcement the researcher did not find any documents regarding the ability to use, release, or accept through concessions by relevant parties and where possible by customers. Regarding this, the respondent replied "Yes" in the ICQ, while on the ground there were no activities or documents regarding the SOPs. 2. Based on the observations made by the researcher on the improvement SOPs picking test for SOPs point 3a, there is no review of discrepancies in the product, including customer complaints. Regarding this, the respondent replied "Yes" in the ICQ, while on the ground there were no activities or documents regarding the SOPs. 3. TEC Indonesia still uses a manual system for writing visual inspection instruction documents. Visual inspection instruction is an important document in product inspection that contains all product identities and a description of the steps of the inspection process. The Quality Control Product Department has reported the assessment documents in accordance with standard procedures at the company 4. Absence of re-verification for remedial actions within the department so as to allow the product to be incompatible repeatedly.

CONCLUSION
Based on the discussion that the author describes it can be concluded that TEC Indonesia in the conformity of the SOP analyzed based on ISO 9001: 2015 regarding product quality control is appropriate. Based on the interviews obtained, it resulted in a percentage of compliance rates of 92.8%, but in the field work or employee compliance levels that were not optimal, there were often repeated inappropriate items.
In the audit picking test conducted by the author, there are procedures that have not been carried out in the company as corrective actions, such as point 3b of the control SOP, namely that there are no documents or actions regarding the ability to use, release, or accept through concessions by relevant parties and, if possible, by customers. Then, in the SOP for improvement, point 3a is the absence of a review of discrepancies in the product, including customer complaints. So, in this case, the author implies that the resulting percentage is 78.5% with a level of compliance regarding quality control procedures analyzed based on ISO 9001:2015.
With the description above, the author provides recommendations so that there is no human error in the company, TEC Indonesia, to process documents appropriately on the work process based on company procedures both in control and repair documents. Reviewing products that are not suitable so that they become material for consideration and evaluation in the future. Re-verify to review noncompliant products repeatedly and implement them correctly. In the discussion above, the author can provide advice to TEC Indonesia, namely evaluating written documents related to control and repair procedures so that employees can understand correctly about control and repair measures for products that are not suitable.