Establishing international laboratory certification and risk management procedure according to the ISO/IEC 17025 the Pingtung Aquatic animal Laboratory as a case study
Chia-yin Chen
Abstract
The ISO/IEC 17025 International Standard specifies the general requirements for the competence, impartiality and consistent operation of laboratories and enables them to thereby promote confidence in their work both nationally and around the world. Risk management processes are often undertaken to enable laboratories to consistently inspect and identify possible risk factors hidden in the operation process of the laboratory and to deal with them with appropriate measures in time.
Risk factors are inevitably involved in laboratory operations and can be simply classified as external and internal risks. For instance, client complaints, policy changes, and the international turbulence are common external risks; on the other hand, common internal risk factors include employee training, the maintenance of experimental instruments, and the loss or damage of critical documents. In order to deal with these troublesome situations, the process of risk management is introduced into many operations.
The essence of risk management processes is to minimize the threat brought by risk factors through appropriate measures under risk-involved environments. Unlike the “Correction” process normally taken previously by laboratories which only fixes individual nonconformities, the risk management process introduces a much more comprehensive “Prevention” concept. After the amendment of ISO/IEC 17025: 2015 version, how to realize the essence of the risk management process has become a new task for accredited laboratories to carry out. Poor risk management not only sabotages laboratory operations, but also give rise to new crises; whereas excellent risk management prevents potential risks as well as promotes laboratory credibility.
As an example, at the Pingtung Aquatic Animal Laboratory, it was determined that quality management problems were the root cause of non-compliance for certain products from the 2015 to present. The laboratory employed the PDCA management cycle mode (Plan→Do→Check→Action) for cause analysis and risk assessment, and after the implementation of corrective measures, we were able to successfully lower the risk factors to an acceptable low-risk level and maintain consistent surveillance on laboratory operations. Currently, the laboratory continues to collect relevant case studies for analysis and discussion, in order to optimize the risk management capabilites of the laboratory.
Investigation of important aquatic pathogens
Chien Tu
Abstract
Since 2014, a newly emergent shrimp virus, decapod iridescent virus 1 (DIV1), has infected most cultured shrimps, especially for Litopenaeus vannamei, Cherax quadricarinatus and Macrobrachium rosenbergii . Recently, DIV1 caused severe die-off in shrimp farms in 11 provinces in China. We have achieved an investigation on shrimp samples of 160 shrimp farms, 24 shrimp hatcheries, 42 Chinese mitten crab farms from 14 counties/cities (New Taipei, Taoyuan, Hsinchu, Miaoli, Changhua, Yunli, Chiayi, Tainan, Kaohsiung, Pingtung, Taitung, Hualien, Ilan, and Kimen)and 33 batches of imported shrimp larvae using two quantitative polymerase chain reactions (qPCR) and a nested PCR (nPCR) methods. Out of 160 shrimp (white leg shrimp, giant river prawn, red claw crayfish, and black tiger shrimp) investigated farms, there were 22 farms tested positive for DIV1, including 17 farms of red claw crayfish, 4 farms of white leg shrimp, and 1 farm of black tiger shrimp farm. The results showed that the inapparent red claw crayfish with no clinical signs should play a role in a reservoir of DIV1.