Showing posts with label Quality Audit. Show all posts
Showing posts with label Quality Audit. Show all posts

Sunday, 11 November 2012

Quality HR – overview of ISO9001 requirements on HR 1


Quality HR – overview of ISO9001 requirements on HR part1

HR can’t run away from been audited in ISO9001 internal or certification audit. Even in customer audit, HR also become the favourite place during the audit. WHAT the auditor looks during the audit?
Let see what is the requirements first!

First requirement:
ISO9001 clause:

4.1 d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes.



This requirements, required that each process in organization should be assigned with resources. The common practices is that the procedure or process flow, should in the person in charge “PIC” for each of the processes.

Example:

Sales process – Sales manager
Production process – Production manager
Prepare quotation – sales executives

Common findings in this clause is that some of the process i.e. calibration, the organization does not assigned the resources. This is commonly due to organization does not define the process at first place.


Second requirement

5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.

How to comply with this requirements?

Quite common, the organization should have the organization charts. The organization chart indicated the job position and hierarchy of reporting the organization. This the base line to comply with this requirement.

Next, when organization, prepared the procedure, the job position can be referred to the procedure.

The best PRACTICE to comply with this requirements is to prepare the JOB DESCRIPTION.

Why job description (see Quality HR _ Job description), it summarized the whole responsibility, authority instead need to refer to each procedure for roles and responsibilities.

Common findings in this clause is when the organization chart changes, i.e. the job position changes, the procedures and the job description not been updated.


Third requirements

6.2 Human resources
6.2.1 General
Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.
NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.

COMPETENCY REQUIREMENTS included :SETE: SKILL - EDUCATION - TRAINING - EXPERIENCES. One of the way to comply is to develop the comptency matrix for the department and then derived it into the JOB DESCRIPTION.

Common findings in this clause is the organization are the competency requirements not been defined clearly for the tasks defined.

6.2.2 Competence, training and awareness
The organization shall
a) determine the necessary competence for personnel performing work affecting conformity to product
requirements,
b) where applicable, provide training or take other actions to achieve the necessary competence,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).

Common findings in this clause is the organization does not identify the training based on the gap in comptency requirements. Secondly the training, not able to be provided as per Training Need Analysis (TNA) and does not remark any reason why and also unable to prioritized the training. Next common finding is that the staff does not aware on the  importance of their activities and how they contribute to the achievement of the quality objectives, (d), and finally the record of evaluation was not updated.

ALL THE BEST

-CER-

Sunday, 4 November 2012

Quality Audit - 80% tak suka kena audit


80% Tak suka kena audit

Lebih daripada 80%, menyatakan mereka tidak suka KENA audit sistem pengurusan. Ini adalah berdasarkan survey yang dijalan kepada lebih daripada 30 organisasi dan responden seramai 180 auditee. Mereka yang tidak pernah kena audit tidak dimasukkan kedalam data.

Tadi tambah lagi 16 orang (semasa training OHSAS internal auditor) dan keputusan dia adalah 93% iaitu seorang sahaja yang suka KENA audit.
Antara alasan yang diberikan:


-          Leceh
-          Menyebabkan diaorang banyak kerja
-          Auditor banyak soal
-          Kena marah dengan boss kalau byk finding
-          Dan berbagai lagi
-          Ganggu waktu kerja
-          Cari salah orang 
-          Risau ada kekurangan 
-          Buka fail lama 
-          Auditor tak faham proses 
-          Permintaan terlalu banyak dari auditor

Fenomena ini perlu di tambah baik kerana tujuan asal audit adalah baik, iaitu meyemak sistem samada ia adalah efektif atupun tidak.
Jadi, apakah yang perlu dilakukan oleh auditor untuk menjadikan audit ini, adalah satu program yang disukai oleh auditee?

Auditor, cuba fikir-fikirkan

-CER-
Di KERTEH
4 Nov 2011

Quality Audit - Auditor competency requirements

EFR Certification SOP71 Auditor competency requirements
Quality Audit - Auditor competency requirements


Untuk menjadi lead auditor, Adakan WAJIB hadiri kursus IRCA ataupun RABQSA?
Jawapannya adalah...... TIDAK tetapi boleh juga YA

TIDAK kerana auditor qualification adalah berdasar “Prosedur” organisasi it sendiri termasukkanlah badan persijilan. Tetapi untuk badan persijilan mereka perlu mamatuhi clause 7.2 (nota kat bawah) dan pada clause 7.2.5 ada menyatakan kena ikut ISO19011. Bila baca ISO19011, tak ada menyatakan KENA attend training anjuran IRCA mahupun RABQSA.

YA jika organisasi itu mewajibkan attend kursus anjuran IRCA atau RABQSA.
Tetapi... ada juga kelebihan join training akredited IRCA kerana mereka ni dah famous dalam bidang ni.

Kenapa IRCA famous... Mereka adalah antara pioneer dalam meng“qualify”kan dan system mereka adalah mematuhi standard ISO19011:2002, kalau dulu mereka terlebih dahulu mematuhi standard ISO10011:1991, 14011. IRCA juga dibawah Chatered Institute of Quality, UK. Biasala... orang akan cakap..... “UK tu beb”. Oleh sebab itu, kebanyakkan “certification body” atau badan persijilan ISO, memerlukan lead auditor mereka berdaftar dengan IRCA ataupun sekurang-kurangnya telah menghadiri kursus LA akredited dibawah  IRCA.

Yang kedua famous adalah RABQSA, dimana mereka adalah based di US. Dulu IRCA dan RABQSA recognised each other. Tapi start July 2012, mereka berpecah.

Jadi apa keperluan untuk kompetensi auditor. Seeloknya attend training accredited to ISO17024 seperti diberi contoh dalam ISO19011:2011.  Bolehlah refer pada contoh daripada prosedur EFR Certification yang diambil dari ISO19011:2002. Teteapi ada beberapa tambahan yang akan dilakukan bedasar ISO19011:2011 dalam masa terdekat.

http://efrmanagement.com/Audit/SOP71%20Rev00%20Management%20and%20Auditor%20Competency.pdf

www.efrcertification.com

-CER-
Dari Bandar Seri Kerteh
4 Nov 2012




NOTA 1: ISO17021 clause 7.2
7.2 Personnel involved in the certification activities
7.2.1 The certification body shall have, as part of its own organization, personnel having sufficient
competence for managing the type and range of audit programmes and other certification work performed.

7.2.2 The certification body shall employ, or have access to, a sufficient number of auditors, including audit team leaders, and technical experts to cover all of its activities and to handle the volume of audit work performed.

7.2.3 The certification body shall make clear to each person concerned their duties, responsibilities and authorities.

7.2.4 The certification body shall have defined processes for selecting, training, formally authorizing
auditors and for selecting technical experts used in the certification activity. The initial competence evaluation of an auditor shall include a demonstration of applicable personal attributes and the ability to apply required knowledge and skills during audits, as determined by a competent evaluator observing the auditor conducting an audit.

7.2.5 The certification body shall have a process to achieve and demonstrate effective auditing, including the use of auditors and audit team leaders possessing generic auditing skills and knowledge, as well as skills and knowledge appropriate for auditing in specific technical areas. This process shall be defined in documented requirements drawn up in accordance with the relevant guidance provided in ISO 19011.

7.2.6 The certification body shall ensure that auditors (and, where needed, technical experts) are
knowledgeable of its audit processes, certification requirements and other relevant requirements. The
certification body shall give auditors and technical experts access to an up-to-date set of documented
procedures giving audit instructions and all relevant information on the certification activities.
7.2.7 The certification body shall use auditors and technical experts only for those certification activitieswhere they have demonstrated competence.
NOTE Assignment of auditors and technical experts to teams for specific audits is addressed in 9.1.3.

7.2.8 The certification body shall identify training needs and shall offer or provide access to specific training to ensure its auditors, technical experts and other personnel involved in certification activities are competent for the functions they perform.

7.2.9 The group or individual that takes the decision on granting, maintaining, renewing, extending,
reducing, suspending or withdrawing certification shall understand the applicable standard and certification requirements, and shall have demonstrated competence to evaluate the audit processes and related recommendations of the audit team.

7.2.10 The certification body shall ensure the satisfactory performance of all personnel involved in the audit and certification activities. There shall be documented procedures and criteria for monitoring and
measurement of the performance of all persons involved, based on the frequency of their usage and the level of risk linked to their activities. In particular, the certification body shall review the competence of its personnel in the light of their performance in order to identify training needs.

7.2.11 The documented monitoring procedures for auditors shall include a combination of on-site observation, review of audit reports and feedback from clients or from the market and shall be defined in documented requirements drawn up in accordance with the relevant guidance provided in ISO 19011. This monitoring shall be designed in such a way as to minimize disturbance to the normal processes of certification, especially from the client's viewpoint.

7.2.12 The certification body shall periodically observe the performance of each auditor on-site. The
frequency of on-site observations shall be based on need determined from all monitoring information available.

Monday, 29 October 2012

Quality Audit - Why Fail 2


Quality Audit

WHY QUALITY AUDIT FAIL?

(NOT EFFECTIVE)

REASON 2
AUDITOR not COMPETENT



This is the toughest success factors to achieve. Common ISO definition of comptency are based on SKILL, EDUCATION, TRAINING, EXPERIANCE (SETE), but it is not easy to achieve. WHY? Because there are other factors that interrelated i.e.
1. Audit objective
2. Audit type i.e level or layered
3. Audit process
4. Auditt Tools
and many more

All this required CLEAR "SETE" 
Based on case study only 1 out 10 organization CLEARLY DEFINED the competency criteria based on PROCESS that they audit i.e. to audit PURCHASING what is the SETE for the auditor(s) to audit Purchasing process?





Some of recommendation from ISO19011


•Relaxed and Friendly
•Good Listener / Communicator
•Interested
•Objective and Logical
•Positive attitude
•Explains the process
•Gives good feedback
•Excellent Interpersonal Skills
•Should ‘motivate’ and ‘facilitate’
•Enquiring Mind
•Can communicate at all levels of the organisation
•Understands the Technology

Wednesday, 24 October 2012

Quality Audit - Why FAIL (1)


Quality Audit

WHY QUALITY AUDIT FAIL?

(NOT EFFECTIVE)


REASON 1
NOT clearly DEFINE AND CLEAR ON OBJECTIVES OF AUDIT

Top Management, Auditor, Auditee, most of them thinks AUDIT is to find fault or JUST one of requirements to certified to ISO

But seldom the organization defined in their audit process, what is the objective in Qualitative manners i.e.
After audit
-        -   to reduce reject by 20%
-         -  to achieve ZERO Error in assembly

There are many other objective of AUDIT depending on what we want and the literature BELOW describe some of objectives of audit (Happy Reading)

------------------------------------------------------------------------------------------------------------
Quality audit can be categorized into compliance audit and management audit (Arter, 1994). Compliance audit look for conformance to the audit criteria, while management audit look for conformance to the audit criteria and the effectiveness of the process and opportunities for improvement in achieving organization goals. Example of conformance audit includes financial audit, tax audit, and regulatory audit. The management audit includes manufacturing audit, product and process audit, improvement audit, and diagnosis. The result of audit, normally presented as an audit report together with audit evidence. Hence the quality audit is categorized under management audit.

The objectives of audit are to look for conformance to a set of rules and the effectiveness of those rules in achieving organization goals (Arter, 1994). The set of rules and effectiveness of those rule refer to audit criteria. ISO 19011 (2002) used the term of audit criteria which is refer to specification, guideline, and requirements. The audit criteria vary from different type of audit. Quality audit criteria also can be refers as the objective of the audit. The most common criteria for quality audit is quality management system audit either it is first party, second party or third party audit as described in chapter 1.

Apart from quality management system audit, the quality audit also cover the specific performance improvement criteria. The review was undertake for research or work that been done regarding the quality audit apart from quality management system audit for the past 20 years. The objective of quality audit is table out in table 2.2.
Table 2.2: Objective of audits
Author (s)
Objectives of audit
Research method,  sample size (n)
Type of Industry or applicability
Significant contribution
Bobbit, 1989
Supplier Quality Audit
Nil
Nil
2 types of supplier audit. 8 categories for area to be audited
Hum and Leow, 1994
Manufacturing strategy
Survey, 55
Electronic in Singapore
Framework empirical studies of Hayes and Wheelwright, 1984
Martino, 1994
Technology
Nil
Nil
Framework for technology audit
Gardiner and Gregory, 1996
New Product Introduction
Case Study, 2
Telecommunication
Framework of NPI audit
Bitichi, 1997
Integrity of performance measure
Case study, 1
Small Engineering manufacturing firm
Workbook to conduct audit
Branney, 1999
Process Optimization
Action Case Study, 1
Fertilizer
3 phased of analysis. 86 improvements ideas. Potential hard saving of USD 2 millions
Lee and Quazi, 2000
Self assessment for quality awards
Questionnaire analysis, 200
Singapore firms
Self assessment methodology
Hepner,Wilcock and Aung, 2004

use of auditing as a tool for continual
improvement

Case study, 4
Meat industries
Application of audit
Gordon, 2005
Supplier performance measure
Nil
Nil
7 steps to measure supplier performance

The literature on quality audit by Skinner (1978, 1985), Platt and Gregory (1990, 1992) contribute their work to formulate manufacturing strategy through the use of quality audits. The work of Skinner, Platt and Gregory were further study by Menda (2005). Menda criticized that the previous audit framework does not provide alternative to the manager. The audit tools and techniques develop by Menda is very useful to start for quality audit in different audit criteria.

Bobbit and Gordon (1989) and Gordon (2005) presented the need of supplier audit. There are series of quality audit namely supplier audit commonly conduct by customer’s auditor or contracted auditor to verify supplier quality performance. Commonly, customer specifics requirements i.e. Ford Specific Requirements are used as audit criteria. Most of customer specifics requirements are adopted from quality management system requirements i.e. ISO9001 and ISO/TS16949 i.e. Visteon, Delphi, TRW, GM, DCM specific requirements.

Gardiner and Gregory (1996) proposed the method to audit the New Product Introduction process with the main objective to propose process re-design based on comprehensive audit of existing New Product Introduction process. Quality audit also has been used to determine flexibility requirements in manufacturing facilities (Das and Patel, 2002). The audit focus whether the organization should introduce or improve flexible manufacturing and at the same time evaluate the impact of the changes proposed on the performance.

Lee and Quazi (2000) described the award based auditing through self assessment and verification from relevant body through report compile from organization and site audit. The most common award based were Malcomn Baldridge quality award.

In summary, the type of audit was depending on audit criteria or objectives. The most common audit objectives and criteria included:
i.                    Specific improvement activities audit
ii.                  Management system requirement i.e. ISO9001 Quality Management System requirements for QMS certification audit
iii.                Customer specifics requirements i.e. Ford Specific Requirements for supplier audit
iv.                Award Based Criteria i.e. Prime Minister Quality award for assessment on best practice





Thursday, 18 October 2012

Quality Audit: Critical Success Factors


WHY  quality audit:
-          Not deliver added value to organizations.
-          Cost added activities
-          Fail improve the organization performance.

There are six FACTORS extracted from Literature review and confirmed by survey, which are 

TAA AAT

TOP MANAGEMENT (CSF1)
AUDIT PROCESS (CSF2)
AUDITOR (CSF3)
AUDITEE (CSF4)
AUDIT EVALUATION (CSF5)
TOOLS AND TECHNIQUES (CSF6)

A bit detailed of literature as followed: (for those interested to read.... :)

There are several factors in quality audit implementation that may contribute to the criticism of quality audit:. 
Not deliver added value to organizations.
Cost added activities
Fail improve the organization performance.

Russel and Regel (1996) described that the factors are due to incomplete process of quality audit or failure to closed the quality audit loop. M. Rajendran and Devadasan (2005) conducted detail literature research in quality audit in order to explore the current status, prowess, and future of quality audits to assist both researchers and practitioners to adopt quality-auditing practice for achieving the objectives of continuous quality improvement (CQI) models like total quality management (TQM). The research indicated various quality-auditing techniques shall be examined. The main area that considered lacking was no linkage to tangible performance measure of quality audit. Performance measurement is very important for the effective management of any quality initives of organization. According to Deming without measuring something, it is impossible to improve it. Therefore, to improve effectiveness of quality audit, one needs to determine the extent of quality audit implementation and measure its impact on business performance. Kaplan and Norton (1996) emphasized that financial indicators would measure the organization past performance. Therefore, in  non-financial categories should be added to measure the organization. 

Quality audit only can be realised with the auditors.  In 1984, ASQC was developed certification exam and in 1986 the committee published the guidelines for Auditing of Quality Systems. Later, more quality audit guideline was published included ISO10011 (1991), ASQ Quality Audit Handbook (1997 and 1999)  and the most recent was ISO19011 (2002) that described the competency requirements of the auditor. Hawkes and Adams (1995) have appraised the important role to be played by the quality auditors and listed the characteristics required by quality auditor. Thus, the quality auditor was considered as one of quality audit implementation issues.
           
Others implementation issues was to consider the total quality management (TQM) and Quality System (QS) implementation issues. Since quality audit is part of TQM and QS, quality audit was assumed to share the same issues with TQM and QS. Dale et al. (1997) have used a TQM sustaining audit tool to examine the sustainability of TQM. Saraph et al. (1989) iniated the study on TQM implementations issues and developed 78 items related to TQM practices, and classified into eight critical factors to measure the performance of TQM in an organization. The studied labelled these critical factors as: 1) Role of top management, 2) role of TQM and organizational performance of the quality department, 3) training, 4) product and service design, 5) supplier quality management, 6) process management, 7) quality data and reporting, 8) and employee relations. Flyyn et al. (1994) developed another instrument which that was close resemblance to the preceding instrument developed by Saraph et al. (1989). More theoritical was developed the theoretical foundation of total quality management practice (Anderson et al. ,1994; Yusof and Aspinwall, 2000) and all the scholars agreed that top management, the organization itself, process management, tools and techniques and reporting as the critical factors for TQM and QS. Hence, focused on the above factors were considered during the development of effective quality audit framework.
            
The issues and the criticals factors were considered as the baseline for current quality audit framework reviews discussed in next section as followed:
-          Top Management commitments
-          Quality audit processes
-          Quality audit tools and techniques
-          Quality of auditors
-          The organization audited
-          Quality audit performance measures 

Have a nice day

Edly Ramly
18 Oct 2012