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