Internally or Externally Internal Audit?

Management systems (e.g. ISO 9001, ISO 14001, ISO/IEC 17025, ISO/IEC 15189, OSHAS 18001, ISO 22000, ISO/IEC 27001 and ISO 30301) were built on processed based approach that assimilates the commonly known PDCA/PDSA cycle, made popular by Dr W. Edwards Deming. The cycle describes that good practice of managing of any activity starts with the planning (P for Plan) on how to carry out the activity in order to achieve customer satisfaction. Usually target (objective) of the activity are set to reflect key perception of the customer that should satisfy the customer expectation. Subsequently, the plan is executed (D for Do), then it is evaluated (C for Check or S for Study) whether the execution was effective in achieving the planned objective. Subsequently, action (A for Act) is taken to improve the activity based on the evaluation findings to meet the original objective. Occasionally, the A will trigger a revised P for the next cycle of the activity. Hence the PDCA cycles continuous as long as there is an activity to satisfy the person who requested the activity, i.e. the customer.

One of the instrument of checking (C) or study (S) is by conducting Internal Audit, also known as "first party audit". The word "internal" reflects that it is initiated within the organization, especially by the owner of the activity. Knowing that self-checking by the person who conducted the activity is inadequate to build confidence, often another person who is very familiar with organization's implemented systems and the P (e.g. the procedure, time, objective) of the activity is engaged as the second pair of eyes (aka Internal Auditor) to evaluate the executed activity. In the event, the activity did not adhere to the organization's system or the predetermined P, the internal auditor would suggest doable actions (A) to correct and improve the activity while taking into consideration of the organization resources, priorities and limitations, which were the factors that influenced the initial P and D of the activity.  

 

For various reasons, there is an option to engage person outside the organization to perform the role of Internal Auditor on part-time basis, whereby the person only present at the organization during the audit sessions, often unaware the organization operational resource and progress. I call this Externally Internal Audit. In general, it is allowable but it may have serious disadvantages to the overall management system of the organization. Hereby listed some of the issues that I've seen while performing 3rd party auditing:

• The organization's human resource loses opportunity of job enrichment via internal auditing because they don't experience the whole activities within the management system in realizing the product.

• The organization's human resource lacks appreciation on the importance of their activity to entire management system because they can't see the impact to other activities throughout the organization.

• The organization's human resource lacks understanding on the mechanics of organizational continuous improvement in relation to preventive actions because they implement PDCA in isolation of their own activity.

• The organization's human resource i.e. the auditee sees the internal auditor as the "problem maker - fault finder" not as "problem solver" because the person is not considered as part of the "family" thus creating stressful and non-constructive internal auditing sessions.

• The internal auditor often performs audit (C or S) similar to the "3rd party audit" whereby only non-compliance is highlighted without advising actions (A) to be taken to resolve it.

• The internal auditor often recommends actions (A) without considering the organization's resources, priorities and limitations, consequently organization incurs expenses to remedy a non-compliance.

• The internal auditor tends to dictate/force the auditee to execute the activity (D) in accordance to his/her organization practice, even though the existing D meets the P, causing non-essential purchase of resources.

While maintaining the principles of auditing (integrity, fair, professional care, confidentiality, independence & evidence-based) as described in ISO 19011, whoever been appointed as the internal auditor (internally or externally), shall make themselves perceived as part of the family of the organization, "one for all, all for one" in the sole mission of improving the management system of the organization.

Practical Precision - Pricy Perfection

Few hours drive from Bangkok, Thailand, there is a unique wet market known as "train market". The market is assembled very-very close & on the the town's railway track near the Ratyatraksa road. 

Whenever, the train arrives, the stall owners, swiftly pull their stall's shades and re-position once the train passes-by. 

Interestingly their naked eye measurement in setting-up the stalls, product displays and shades are practical to handle and precise enough for the train pass-thru without hitting any of the stalls or their products. It looks impossible but it has been their life routines, they have a very good way in maintaining the "measurement uncertainty", everything is done manually without any automation, sensors or measuring tape, but it works.

 

Measurement is common in our daily life even at kitchen while perfecting recipes. For laboratory, quality of a measurement depends on the capability to perform the measurement at high level of accuracy. Whereby accuracy is dependent on the precision and trueness. 

When an instrument, e.g. weighing scale displays same value of readings in a series of repeated weighing of the same item, it is considered to be very precise. While trueness is reflected by the capability of the weighing scale to display correct value of weight, which is predetermined by means of calibration using standardized weights, also known as "standard stone". Normally, an equipment calibration service will cover both precision and trueness, often represented by the value named "uncertainty of measurement" stated on the calibration certificate.

Definitely, an accurate measurement is a must but the level of accuracy must fits the purpose of measurement. There is tendency for some customers, auditors and laboratory managers to over-emphasize the accuracy level by increasing the readability (e.g. the number of decimals). Without realizing it defeats the cost-effectiveness, which is the ground rule of organizational survival. 

Increasing readability does not necessarily increase accuracy. Let's compare a digital contact thermometer (CT) of 0.5°C readability that costs MYR50 to a digital infra-red thermometer (IRT) of 0.01°C readability that costs MYR500. Both will incur the same fee for calibration services, around MYR120. After calibration for use between 40 to 150°C, both are used to verify temperature of a stainless steel water bath being setup at 50°C, the CT displays 50.5°C and IRT displays 51.02 °C, which one is the best measurement? Knowing the control knob on the water bath shows increment of setting at 1 °C, does the water bath operation require accuracy of ± 0.01 °C or ± 1 °C is adequate for it's temperature setting?  Perhaps it is more convenient with style to use the IRT, but do double check the user manual, don't be surprised to read that some IRT not intended for measuring temperature of metallic surface. 

Balancing Weighing Balance

Often during OECD - GLP inspections, ISO 9001 audits and ISO/IEC 17025 assessments we come across weighing balance as it is a must equipment in preparation of test item, reference materials and production ingredients. One of the typical component of the weighing balance is the level-indicator, which consists of a gas bubble within a circle. The leveling (balancing) is an important prerequisites in operating any balance at laboratory. The balance is leveled when the bubble stays in the circle without touching the circle line. Once the bubble touches the circle line, the measurement of the weight (mass) starts to drift and becomes inaccurate. Eventually the weight measurement is incorrect when the bubble crosses the circle line. Most models of weighing balance is unable to perform auto-leveling even for a calibrated balance. Thus laboratory personnel plays an important role to ensure measurement of weight without error.

Seringkali ketika pemeriksaan OECD - GLP, audit ISO 9001 dan penilaian ISO/IEC 17025, kita akan bertemu alat penimbang berat yang merupakan satu alat wajib dalam penyediaan bahan ujian, bahan rujukan dan ramuan pengeluaran. Satu daripada komponen yang lazim terdapat pada alat penimbang ialah penunjuk - pengarasan yang terdiri daripada satu gelembung gas di dalam bulatan. Mengaras (mengimbang) kedudukan penimbang adalah satu prasyarat penting semasa menggunakan penimbang di makmal. Kedudukan penimbang telah teraras apabila gelembung berada di tengah bulatan tanpa menyentuh garis bulatan. Sebaik sahaja gelembung menyentuh garis bulatan, penyukatan berat (jisim) mulai hanyut and menjadi tidak tepat. Akhirnya penyukatan berat adalah tidak betul apabila gelembung melintasi garis bulatan tersebut. Kebanyakan model alat penimbang berat tidak berupaya melakukan pengarasan secara automatik walaupun telah dikalibrasi. Justeru, kakitangan makmal memainkan peranan penting untuk memastikan penyukatan berat tanpa ralat.

Expiry Before Expiry

Chemical consumables at laboratory includes acid, alkaline, solvent, reagent and many more types chemical substances. It is an universal good practice for laboratory personnel to take note of expiry date stated on the container of the chemical substance. The expiry date reflects that within the stipulated date, the chemical characters (specification) of the substance, e.g. chemical structure, purity, specific gravity, density etc. remain the same without any changes. This assumption allows chemical processes to be performed with certainty of the expected outcome. Often the laboratory personnel tends to overlook that the expiry date is very much dependent on the storage conditions namely temperature, moisture and light. Therefore the right SOP in handling and storage of the chemical substance, and not to forget the monitoring plus recording of the storage condition are crucial to sustain the chemical substance lifetime. In addition, some chemical substances are known to have good stability with long lifetime of more than 10 years yet its container states expiry date of less than 5 years. The reduced expiry date is determined by the container's integrity (bottle & cap) in providing secure and safe storage of the chemical substance. Change on the physical appearance of the container is a sign that the chemical substance has been exposed to extreme environmental condition. Thus, please bear in mind that chemical substance may expire before expiry date.

Pakai habis kimia di makmal merangkumi asid, alkali, pelarut, reagent dan banyak lagi jenis bahan kimia. Satu amalan umum yang baik untuk kakitangan makmal adalah mengambil tahu tarikh luput yang dicatatkan pada bekas bahan kimia. Tarikh luput tersebut mencerminkan tempoh sebelum tarikh tersebut, sifat (spesifikasi) kimia bahan berkenaan, contohnya struktur kimia, ketulenan, graviti spesifik, ketumpatan dan sebagainya kekal tanpa sebarang perubahan. Andaian ini membolehkan proses-proses kimia dijalankan dengan pasti untuk mendapatkan hasil yang dijangkakan. Seringkali kakitangan makmal tidak sedar bahawa tarikh luput tersebut sangat bergantung kepada keadaan penyimpanan seperti suhu, kelembapan and cahaya. Justeru, prosedur kerja tetap (SOP) yang betul dalam mengendali dan menyimpan bahan kimia, dan tidak melupakan pemantauan termasuk merekod keadaan penyimpanan adalah mustahak untuk mengekalkan hayat bahan kimia. Tambahan pula, sesetengah bahan kimia diketahui memiliki kestabilan yang bauk dengan hayat yang panjang melebihi 10 tahun, namun bekas bahan kimia tersebut menyatakan tarikh luput yang kurang dari 5 tahun. Pemendekan tarikh luput itu ditentukan oleh integriti bekas (botol & tudung) dalam menyediakan penyimpanan bahan kimia yang selamat. Perubahan fizikal pada bekas adalah satu petanda bahan kimia tersebut telah didedahkan kepada keadaan persekitaran yang melampau. Oleh itu, sila ambil peduli bahawa sesuatu bahan kimia boleh luput sebelum tarikh luputnya.

Career is "Kerja Yang Berjaya"

Laboratory personnel significantly effects the quality of any testing. Job security by means of career growth may offer better stability of laboratory work force. Career in Malay language is "Kerjaya", which I view as a combination of two words Kerja (Job) yang Berjaya (Successful). It also illustrates important characters to be displayed by laboratory personnel as pre-requisites to gain job security from laboratory management.

K is for "Kuat" means Strong; physical (PQ), intelligent (IQ), emotional (EQ) and social (SQ) qualities
E is for "Emas" means Gold; embraces work practices of gold standards
R is for "Rajin" means Assiduous; work diligently and persevere challenges
J is for "Jimat" means Cost-Conscious; prudent spending of resources
A is for "Amanah" means Trustworthy; dependable to execute authorities
Y is for "Yakin" means Confident; show ability to perform responsibilities
A is for "Aspirasi" means Aspire; moving forward higher quality goals

"Six Million Dollar Man"

An investor may spent $6 million in setting up a chemical testing laboratory, cost covering its building, equipment, environmental monitoring system, utility and supplies. However without a registered chemist, the laboratory may not acquire international accreditation (ISO/IEC 17025) essential to assure competency to its customer and stakeholders. The registered chemist is an asset and liability for the continuity of the $6 million chemical testing business. Hence, a tip to laboratory management; do allocate adequate portion of the $6 million take care the career path of your key personnel especially those signing your test reports and establish contingency plan for replacement chemist to safeguard your business interest.

Pelabur boleh membelanjakan $6 juta untuk menubuhkan satu makmal pengujian kimia, meliputi kos bangunan, alatan, system pemantauan persekitaran, utility dan bekalan. Namun begitu, tanpa seorang ahi kimia berdaftar, makmal tersebut tidak akan memperolehi akreditasi antarabangsa (ISO/IEC 17025) yang mustahak to menjamin kompetensinya kepada pelanggan dan pihak yang berkepentingan. Ahli kimia berdaftar tersebut adalah satu aset dan liabiliti kepada kesenambungan perniagaan pengujian kimia yang bernilai $6 juta. Justeru, satu tip kepada pengurusan makmal; bajetkan dengan mencukupi sebahagian daripada $6 juta tersebut untuk menjaga perkembangan kerjaya kakitangan yang penting khususnya mereka yang menandatangan laporan ujian dan wujudkan pelan kontijensi bagi penggantian ahli kimia tersebut untuk melindungi kepentingan perniagaan anda. 

Being At The Same Height Worldwide

The International Standard Weight (Mass) Used to Calibrate National Standard Mass Worldwide at BIPM, France. Without BIPM initiatives, the mass of 1 kg of sugar in Malaysia may differ with 1 kg of sugar in Japan. Imagine the length of 1 meter not standardized worldwide, you height would vary between countries :-) Traceability to SI units is fundamental of world economy, thus another important tips is to make sure your production measurement devices are calibrated by accredited laboratory.

Pemberat (Jisim) Piawai Antarabangsa yang Pernah Digunakan untuk Kalibrasi Jisim Piawai Kebangsaan Seluruh Dunia di BIPM, Perancis. Tanpa usaha BIPM, 1 kg gula di Malaysia mungkin berbeza jisimnya dengan 1 kg gula di Jepun. Bayangkan panjang 1 meter tidak dikalibrasi diperingkat dunia, tinggi anda akan berbeza mengikut negara :-) Kebolehan untuk menjejak sukatan kepada unit SI adalah asas ekonomi dunia, justeru satu lagi petua yang mustahak adalah memastikan alat pengukuran yang digunakan semasa pengeluaran produk telah dikalibrasi (ditentu-ukur oleh makmal bertauliah).