Quality Assurance Intro

Introduction

Quality Assurance (QA) is everywhere in the corporate environment, and it ensures robust/consistent operation within the corporate. In this introduction post, Quality Assurance’s job scope, Quality Management System (QMS), Quality Documentation Level and Quality Auditing Techniques will be explained. 

Quality Assurance Job Functions

Based on the industrial experiences, quality assurance jobs can have the following positions/functions.

Responsible for establishing, implementing, and monitoring quality systems across corporation scope. Generally served as the Quality Management Representative for ISO system

Coordinate the document control center to review, comply, verify and maintain all QMS related documents (from level 1 to level 4)

Implement project/customer requirements into the corporation, prepare customer audit and relative qualification documents from NPI station to mass production.

Assist and maintain regulatory compliance status for product certification, also required for preparing product compliance’s regulatory audit.

Trace and ensure continuous improvement from across the organization from either Corrective Action and Preventive Action (CAPA) plan or other audit failures

Review organization suppliers and execute suppliers’ on-site audits to ensure suppliers are capable based on the corporation’s supplier quality standard.

Finalize internal audit plan and execute internal audit throughout the entire organization

Analyze and investigate claimed products and organize root cause analysis with cross-department function.

Manage calibration plan and execute equipment/instrument calibration across the organization. Certified calibration laboratories shall have ISO/IEC 17025 laboratory certification.

Execute quality control inspection from Incoming Quality (IQC), In-Process Quality (IPQC) and Final/Outgoing Quality (FQC or OQC) while verify product is within the agreed specification.

Quality Management System (QMS)

Quality Management System (QMS) helps and guides corporations to initialize a systematic approach for operation such as organization arrangement, resource planning, product/service realization, and continuous improvement. QMS is essential for product/service-providing corporations since the supplier will use similar or stricter audit methods to ensure the supplier provides qualified products/services.

ISO 9001 QMS Roadmap

As we see the QMS approach, the regulation and customer requirements will always be the initial point for the corporation to build the respective QMS. And QMS will be referred to the four-letter cycle, PDCA(Plan, Do Check, and Act) to improve QMS’ effectiveness and consistency.

When indicating the QMS scope, organization structure, resource management, product realization, measurement, analysis and improvement will always be the core aspect corporation needed for QMS implementation. 

The following chart will be the general breakdown of ISO:9001 2015’s structure and why ISO:9001 is applied here since it’s the bone structure for basic QMS implementation.

ISO 9001:2015 Chapters Breakdown

QMS, in general, is similar to each other ISO clauses, but the ISO application may defer due to the industry application. Regardless, the critical principle for QMS is for the corporation to establish and regulate systematic procedures with transparent records.

ISO standard also varies based on industries, the following are the common standards people will hear:

For automobile industrial product

For medical device industry

For testing and calibration laboratory compliance

For Environment, Health and Safety compliance.

QMS Documentation

Documentation is always critical for QMS to establish proper operation processes, and this post will discuss 4 levels of QMS document which is the general classification for major QMS based companies.

QMS Documentation Hierarchy

Quality manual shall include general abstracts of the quality policy, resource management, product realization, and other essential QMS operation flow.

 

In addition, the quality Manual shall give a clear road map for auditors or people unfamiliar with the corporation’s QMS.

Extended details from the quality manual to prevent the quality manual become over-detailed.

 

Procedures complement the quality manual’s exact details for QMS operations, such as internal audit, supplier quality evaluation, calibration, production management, and many more.

Demonstrate how to initiate and complete respective tasks such as testing instrument operation, quality control measurement operation, production machine operation, and other possible required operations.

 

Having work instruction helps the corporation minimize variation coming from the appraiser’s end and standardize the operation steps.

Provides a way to track and record QMS operation records for monitoring and improvement.

 

Record forms will have necessary formats depending on which application is required, so record forms can vary coming from administrative perspective to product development & manufacturing.

Quality Auditing

Quality audits has always been one of the common manufacturing practices whether it’s getting audited by customers, internally audited or auditing suppliers. In this section, details of quality audits and preparation information will be illustrated based on the cumulative experiences from being audited by OEMs or auditing upstream suppliers.

In general, quality audits will be primary focusing on the following (but not limited) scopes listed below

Before initiating quality audit, the following preparation shall be considered and implemented. 

Quality Audit Preparation

During the on site audit, the following scopes can be broken down for the audit criteria. In addition, the auditors can refer to the 4M1E approach (Man, Machine, Material, Method and Environment) to audit.

Scopes include quality management system’s risk evaluation implementation, roles & responsibilities, quality goals and policies along with training plan/qualifications. 

But different industries will refer to different QMS application. For instance, automobiles will have IATF 16949 in addition to ISO 9001, medical device would refer to ISO 13485…etc.

Information can include designed specification, design transfer record, billing of material, customer notification for change,  product realization timeline (start from New Product Introduction phase all the way to mass production) .

Verification test plans for product trials and respective results. Reports such as functional test report, dimension report, process capabilities can be considered.

On site production management including 5S, process flowchart,  production equipment maintenance record, production control plan, first article inspection, changeover record…etc.

What suppliers do when nonconformity occurred for production, quality system, customer complaints and inspection. This also review the mechanisms of supplier’s corrective and preventive actions. Also need to verify the effectiveness of the nonconformity handling cycle.

Additional recording for information such as production record’s integrity and correctness (Good Documentation Practice), review and questioning from operators, production data and process parameter, error proofing function and risk based approach will be the correct methodology to gather necessary information for validating the compliance for audit items.

Throughout the audit process, auditors shall keep mutual and fair stance to observe the facts and evidences from the audit findings. And also remember to know that audit is an opportunity to find improvement within the system, so how to communicate with suppliers fairly while respecting supplier’s profession is a mutual balance for auditors as well.

Based on the following summaries, the following bullet points will summarize the suggested points to ensure the audit is successful and able to help suppliers identify their opportunities to improve.

In conclusion of the audit, audit reports shall be presented and summarized the audit findings along with improvement requirement. The following bullet points will be the key points to summarize the audit and requesting improvement from suppliers.

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