ISO9001:2015 (Clause 4.4) Quality Management System and its processes: CASE STUDY

PHOTO: FACEBOOK/JUDY TEO's caption

News reported by The Straits Times (11 Oct 2018):
KKH apologises for dispensing expired nose drops to baby, engages independent review panel

Background - The Singapore’s KK Women's and Children's Hospital (KKH) apologised on Wednesday (Oct 10) for dispensing expired nose drops for a baby suffering from fever and flu. KKH said that it has also taken various actions to follow up on the case, which includes engaging an independent review panel to investigate this incident.

Last Monday, netizen Judy Teo, 32, said in a Facebook post that her daughter, who is about two months old now, was issued with nose drops which expired earlier in April. The next day, the hospital said it was investigating Ms Teo's allegations.

Mr Alson Goh, chief operating officer at KKH, told The Straits Times on Wednesday that the hospital acknowledged that the nose drops given to the baby were passed their stated expiry date. He said that this may have resulted in a "loss of effectiveness" of the drops, and that appropriate measures had been reinforced. "We sincerely apologise for this. We are currently engaging with the staff involved," said Mr Goh.

Earlier in May 2018, KKH had apologised after it dispensed the wrong medication to a young girl by mistake. The hospital had given a nasal spray and a bottle of nose drops to the parents of the girl, and only realised later that the medicine had been opened and used before. KKH said then that it was conducting investigations and reviewing internal processes in the light of the incident.

From an ISO Auditor’s perspective, these lapses need to be probed further to determine the root cause(s) to this recurring problems. Investigation should start with the examination of the defined quality management system and its processes (Clause 4.4), especially these sub-clauses’ requirements:

(c) determine & apply criteria and methods (including monitoring, measurements, related performance indicators) needed to ensure effective operation and control of these processes;

(e) assign the responsibilities and authorities for these processes. 
The Auditor could also examine in depth, the QMS’ processes with respect to complying to ISO requirements on these topics:

Clause 5.1.2 Customer focus (top management’s leadership & commitment)

Clause 6.1 Actions to address risks and opportunities

Clause 8.5.2 Identification and traceability (use suitable means to identify outputs…)

Clause 8.5.4 Preservation (identification, handling, contamination control, packaging, storage, transmission, transportation and protection)

Last status check on KKH’s portal: 

https://www.kkh.com.sg/AboutUs/Overview/HospitalMilestones/Pages/Home.aspx

KKH has obtained quality certifications: 

2005 Singapore Quality Award

2013 re-certification of ISO9001 (no renewal status published in portal. Certificate should have been expired in Sep 2018 for obsoleted standard: ISO9001:2008 QMS-Requirements)

ISO9001:2015 (Clause 8.4) Control of externally provided processes, products and services: CASE STUDY

News reported by The Straits Times (25 Sep 2018):

'Fake' marble plaques used for 8,600 niches in Mount Vernon Columbarium relocation exercise’

SINGAPORE - Some next-of-kin promised marble plaques for new niches as part of the Mount Vernon Columbarium relocation exercise realised a similar looking material was used instead. The Straits Times (ST) checked with the National Environment Agency (NEA) and learnt on Monday (Sept 24) that quartz was used for 8,600 niches when they were relocated to government columbaria at Mandai and Choa Chu Kang.

In the above example, the most applicable clause(s) applicable is Clause 8.4.

Here are the requirements:

Clause 8.4.1 General
The organization shall ensure that externally provided processes, products and services conform to requirements.

Clause 8.4.2 Type of extent of control 

The organization shall:

(d) determine the verification, or other activities, necessary to ensure that externally provided processes, products and services meet requirements.

From an ISO Auditor’s perspective, these lapses need to be probed further to determine the root cause(s) to this problem including the criteria used for the evaluation and selection of external providers and the verification processes that products/services provided meet stipulated requirements. In this case, the organization is a regulator offering public services, the ‘real’ root cause(s) might not be published to avoid embarrassment.

Last status check conducted on 10 Oct 2018, the organization is certified to ISO 9001:2008 which has already been expired in Sep2018, 3 years after the issue of ISO9001:2015.

To apply the above obsoleted standard, the same discrepancies would have been marked under:

Clause 7.4.1 Purchasing process

Clause 7.4.3 Verification of purchased product

ISO 45001:2018 Occupational health and safety (OHS) management system

At last, this standard is finally published last week and is to replace OHSAS 18001:2007. Organizations certified to OHSAS normally have 3 years to migrate to the new standard. Management system champions from these organizations should check with their certification bodies on timeline to convert. 

ISO 45001:2018 specifies requirements for an occupational health and safety (OHS) management system and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OHS performance.

ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OHS management system to improve occupational health and safety, eliminates hazards and minimizes OHS risks (including system deficiencies), take advantage of OHS opportunities and addresses OHS management system nonconformities associated with its activities.

ISO 45001:2018 helps an organization achieve their intended outcomes of their OHS management system. Consistent with the organization's OHS policy, the intended outcomes of an OH&S management system may include:

a) continual improvement of OHS performance,

b) fulfillment of legal requirements and other requirements,

c) achievement of OHS objectives.

ISO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to mitigate OHS risks under the organization's control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.

ISO 45001:2018 does not state specific criteria for OHS performance, nor does it prescribe the design of an OHS management system.

ISO 45001:2018 enables an organization, through its OHS management system, to integrate other aspects of health and safety, such as worker wellness and wellbeing.

ISO 45001:2018 does not address issues such as product safety, property damage or environmental impacts, beyond the risks to workers and other relevant interested parties.

ISO 45001:2018 can be used in whole or in part to systematically improve occupational health and safety management. However, claims of conformity to this document are not acceptable unless all its requirements are incorporated into an organization's OHS management system and fulfilled without exclusion.

Continuous Improvement: KAIZEN

KAIZEN (改善) means ‘continuous improvement’.

This concept is not new and was pioneered by Japanese and American gurus notably Deming and Juran since the 1950s.

In Japanese:

KAI = ‘to take apart’

ZEN = ‘to make good’

This means to dismantle/take-apart something in order to make it better.

There are already many tools available today o do Kaizen. Everyone should practise it in work and in our daily lives.

But Kaizen requires thinking and analyses. Only through reflections and thinking can one improves on something. With so many distractions around us these days, how many could actually allocate time to think? I think not much as most of our remaining time are revolve around and consumed by our smart devices and gadgets. Even young children these days have little time to think.

Thinking about improvement is one challenge, while getting business owners and leaders to sponsor changes is another.  Unless ideas are about improving revenues or raising their already inflated egos and status, chances are Kaizen’s efforts would change nothing. Until business owners and leaders have open minds, big listening ears and believe in Kaizen that would improve their organizations and not for personal gains, this concept is just another fad.