Complainant

Respondent

Parties

Conor  O'Neill

Eurofins Professional Scientific Services Ireland Limited

Complainant

Respondent

Anonymised Parties

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Representatives

Mr. Vincent Mc Kechnie BL  instructed by Rachel O'Toole Solicitors

Ms Niamh McGowan BL instructed by  A&L Goodbody

Act

Complaint/Dispute Reference No.

Date of Receipt

Complaint seeking adjudication by the Workplace Relations Commission under Section 8 of the Unfair Dismissals Act, 1977

CA-00041663-001

22/12/2020

The Complainant commenced work with the Respondent on 4 April 2018 as an Analyst, Level 3. His contract was terminated on 17 November 2020. His basic salary was €36,720. The Respondent employs scientists and analysts to provide scientific services on clients’ sites.  The Complainant was employed on a pharmaceutical site where he produced and recorded raw data which was used to ensure the safety and quality of water supply in the production of human medicine products. The Complainant submits that he was unfairly dismissed for gross misconduct, which he denies. He claims that he made a mistake with regard to the input of data and that the dismissal was disproportionate in all the circumstances. He is seeking reinstatement or in the alternative to be compensated for his loss.

The Respondent rejects the Complainant’s allegation that his dismissal amounts to an unfair dismissal. The Respondent submits that the termination of the Complainant’s employment was wholly fair both procedurally and substantively.  

 The Respondent is a life science and biopharma company which provides scientific and technical services to clients on an on-site basis.

Between 4 April 2018 and the date of his dismissal, the Complainant was part of a team of analysts which were assigned to a client to provide laboratory support services. As part of his assignment, the Complainant was responsible for testing water sources for biological and other impurities, amongst other technical duties. Those water sources were then used by the client as a raw material in the production of pharmaceutical products for humans. It is a critical component of the production process, for such pharmaceutical products, that the integrity of water testing is not in any way compromised.

 While carrying out his duties in this role, the Complainant was required under the client's Standard Operating Procedure (SOP) to abide by a strict protocol when analysing microbiological samples. The SOP is governed by Current Good Manufacturing Practice (cGMP) standards, which in turn are monitored by numerous Irish and international regulatory bodies, including the Federal Drug Administration (FDA) in the US, the Health Products Regulatory Authority in Ireland and the European Medicines Agency. The Respondent and client vigilantly observe their respective obligations to remain compliant with the cGMP standards, as this allows the Respondent to offer services to clients which can be trusted. The Respondent is also regularly the subject of audits and inspections by the above-named bodies and must therefore ensure that it can demonstrate compliance at all times.

On 4 November 2020, the Complainant was responsible for reading and recording the results of 30 microbiological plates containing water samples that were being tested. As per the procedure for reading microbiological test plates in the microbiology lab, the reading analyst (in this case, the Complainant) must refer to the incubator map and the printed ‘Smartlab’ visual aid to confirm when the test plates are due to be read, remove plates from the incubator and inspect for microbial growth, and document the incubator removal time in ‘Smartlab’ or the relevant logbook for all samples.  Prior to reading, the analyst must reconcile the plates in the testing session versus the physical plates to ensure that all plates are accounted for. The analyst must then read and enter the result for each plate separately. The results must be entered into ‘Smartlab’ after reading each plate and before reading the next one. Finally, the reading analyst must reconcile all results against each plate before marking the session as 'complete' on Smartlab.

 On the day in question, the Complainant was required to review and confirm the number of plates which were to be reported by him that day. All 30 plates were stored in an incubator with 10 plates in the front section and the remaining 20 in the back section of the incubator. The Complainant, having failed to carefully check the whole incubator, admitted to having read only 10 of the 30 samples that were due to be analysed. However, the Complainant proceeded to enter data into the Smartlab system for all 30 samples, despite having read only 10.

The Complainant did not report this issue at the time. Under the SOP, it is mandatory that analysts only enter data from samples in real time, immediately after they are read. It is also expected that all analysts have the SOP available to hand during these tasks to ensure that their work is in line with the cGMP standards.

 An analyst assigned and responsible for testing and reading microbiological test plates must also perform a routine visual reconciliation exercise of the incubator at the end of each day to ensure all plates due to be read have in fact been removed and read within the specified incubation time. This was not performed correctly on the day in question by the Complainant.

 On the following day (5 November 2020), the Complainant was again responsible for reading and recording the results of microbiological plates containing water samples that were being tested, as well as conducting the routine end of day reconciliation exercise. At this stage, it ought to have been apparent to the Complainant that there were 20 samples which corresponded to the previous day's session. However, the Complainant failed to take notice of this. The Complainant was not at work on 6 November 2020. When the routine reconciliation exercise was undertaken by the Respondent's Quality Control Laboratory Analyst on duty that day, it was discovered that 20 of the plates remained on the shelf from two days previously (i.e. from the Complainant's session), and that the incubator map was clean. The plates did not have accompanying tracking tags, settle plates or controls. The QC Analyst was then able to link these samples to the Complainant's session in the laboratory on 4 November 2020.

At this point, the incident came to the attention of individuals in the client business, who immediately escalated the matter to the Site Manager. The Complainant was contacted by phone on 6 November 2020 and asked about these plates. He could not recall over the phone, and instead asked if he could come onsite the following day to discuss the matter further.

 On 7 November 2020, the Complainant met with the Site Manager and a staff member of the client, at which point the Complainant recalled the test session and demonstrated how he removed the plates from the incubator and read 10 plates. At this point, he acknowledged that he had entered data for 30 plates in ‘Smartlab’ stating that he had been distracted at the time. A decision was made to suspend the Complainant on full pay pending an investigation of this incident in accordance with the Respondent's disciplinary policy.

 The Complainant was advised of this by letter dated 7 November 2020 This letter included reference to the fact that alleged conduct such as this may be regarded as "gross misconduct".  On 9 November 2020, the Respondent invited the Complainant to attend an investigation meeting to be held on 11 November 2020. The Complainant attended the meeting on 11 November 2020, which also attended by the Director of operations for the Respondent in Ireland and the senior HR Manager.  The Complainant was advised that he was entitled to bring a colleague to the meeting for support, which he declined to do.  During the meeting, the Complainant admitted that he did not reconcile the number of plates documented in ‘Smartlab’ with the number of plates in the sample once he had removed them from the incubator and prior to reading them. He stated that he would usually reconcile the number of plates versus the number in the sample, however, he was so busy on the day in question that he did not do it. He further explained that he only read 10 of the 30 samples as he did not see the second stack of 20 further plates. He attributed this to Performance Qualification samples which were also in the incubator on the shelf above which obscured his view of the shelf.

The Complainant further explained that the tagging system on the incubator did not state how many plates were in each group, which, he said, may have been a contributing factor in this incident. He also noted that the data entry system features a time stamp delay which can cause confusion. He did accept that recording all 30 samples without having reviewed 20 of them was an error, and that he took responsibility for that. The explanation offered was that he must have been distracted and this was why he did not notice that he had entered 30 results but only read 10 plates. When questioned, the Complainant also admitted that he did not have the SOP in front of him when reading samples.

Following this meeting, it was determined that the matter should be dealt with under the Respondent's disciplinary policy. The Complainant was invited to a disciplinary meeting which took place on 17 November 2020. During the disciplinary meeting, having considered all relevant factors, including the seriousness of this incident in the context of the cGMP standards, the disciplinary decision makers concluded that this incident constituted gross misconduct within the meaning of the disciplinary policy, and that dismissal was an appropriate and proportionate sanction. This outcome, along with a right to appeal, was communicated to the Complainant on 17 November 2020 by way of letter.

Shortly after issuing the outcome letter, the Complainant advised the Respondent by email that he wished to appeal his dismissal. In his original email response, the Complainant briefly stated that his grounds for his appeal were that:

1.       there were shortcomings in the procedure for tagging samples;

2.        this was his first offence;

3.        this was a matter of human error; and

4.        he was being made an example of in circumstances where this error occurred in the same week in which data integrity was emphasised by the Respondent.

 In response to this email, the HR manager wrote to the Complainant to advise him that it was of the utmost importance that his grounds for appeal were stated in full of as much information as possible, as it may not be necessary that for the manager conducting the appeal to re-interview the Complainant. She then asked the Complainant to confirm that the above-named grounds represented his full grounds for appeal. The Complainant responded in a number of subsequent emails by adding that on the day in question, his father was ill and that this might have contributed to a lack of concentration on his part, and that this matter should be dealt with as a minor misconduct offence in circumstances where "major misconduct is more criminal in nature".

The Respondent appointed a Senior HR Manager and the Senior Manager for Quality, Biopharma Product Testing) to conduct the appeal. Having reviewed the materials from the disciplinary investigation and the emails from the Complainant in which he set out his grounds for appeal, the Senior HR Manager wrote to the Complainant on 24 November 2020 confirming the outcome of the appeal. She responded to each of the Complainant's grounds of appeal as follows:

·         While it was acknowledged that improvements could be made in the sample tagging system, this was not a valid reason for not following the SOP;

·         This incident was not the first time the Complainant had not followed the SOP as he admitted during the investigation meeting on 11 November 2020 that he did not routinely have the SOP open in front of him as required for all analysts who engage in cGMP testing;

·          While it is acknowledged that human error occurs, this issue cannot be attributed to human error, rather a failure to follow the SOP. There is no ambiguity with the SOP that could contribute to the issue in question; and

·         The allegation that the Complainant was made an example of was unsubstantiated, and that the Respondent's attitude towards data integrity was wholly consistent and appropriate.

 The letter emphasised the importance of data integrity, Good Distribution Practice (GDP) and cGMP and that ethical performance and data integrity must supersede all other objective laboratory operations. Accordingly, the Appeals persons upheld the original decision, and affirmed that the decision to dismiss was consistent with the Respondent's policies, training and other similar situations.

Summary of Witnesses’ Testimony:

HR Manager:

All disciplinary policies that were given out to staff upon induction always included a full non-exhaustive list of what constituted acts of gross misconduct. Ethics training and Data Integrity were basic principles upon which the Respondent operated. She believed that the Complainant carried out a deliberate act of gross misconduct.

Director for Operations in Ireland and the UK:

He believes that there was a falsification of data. Dismissal invariably does not follow a minor error and there are instances where people who make minor errors are not dismissed.  In this instance, 20 results were not read, and such an error can never be construed as ‘minor’. It was inexcusable that the Complainant had not read the plates. The whole operation is based upon having trust in the employees and the reputation of the Respondent could be severely damaged if such major events are not punished appropriately. In this instance there was a 100% failure of trust.

Cross-Examination:

He accepted that there may not have been wilful falsification but when it comes to an audit by the FDA, for example, there is no black and white distinction between what is wilful or not.

He said there was no way back for the Complainant even though he had a previous good record and that the Complainant had nothing to gain from his actions on the day. 

Senior Quality Manager (One of the two persons who heard the Complainant’s appeal of Unfair Dismissal):

The Respondent could be debarred if not up to standard if such an event as described was discovered at an audit. Such are the processes employed by the Respondent that daily checks are carried out on the system. If poor water had gotten through, which did not happen in this instance, batches of pharmaceuticals could have been destroyed resulting in the site possibly closing down. She believes data had been falsified here and that the SOP clearly was not followed. She did not accept that it was simple human error or inadvertence.  

She does not believe that standards are being set impossibly high and that this was a clear example of falsification and not a mistake.   

Cross-Examination:

The Manager accepted that the site was not closed down in this instance nor could she be sure that the incident would realistically lead to a closedown of the site. She also acknowledged that had the sample been thrown in the bin and not recorded it may not have warranted a dismissal.

The Manager accepted that she had some, but not extensive experience of disciplinary procedures. She asserted that behaviour modification and a second chance was not an option with such a serious incident.

HR Manager (Recalled):

The HR Manager gave examples of cases where employees were dismissed for falsification of data included forging a colleague’s signature and inputting wrong dates. Errors are sometimes made, and it does not result in dismissal. She asserted that in this instance the Complainant had decided not to follow GMP. She believes that the gain for the Complainant was that there was a shortening of the procedure he was engaged in.  The HR Manager exhibited slides of the induction process where it states that wilful falsification of documents will result in dismissal.

The HR manager stated that re-instatement on another site was not considered because it was realised that all trust in the Complainant had disappeared.

Cross-Examination:

The HR manager accepted that the Complainant was normally very obliging if at times the progress of his work could have faster. She acknowledged that the incident with the plates could be described as a ‘bolt out of the blue’.

Legal Argument:

The Respondent submits that the dismissal of the Complainant was both procedurally and substantively fair, and that the Complainant is not entitled to reinstatement, re-engagement or compensation in accordance with the Unfair Dismissals Act 1977, as amended (hereinafter “the Act”).

Relevant Legislation

 Section 6(1) of the Act provides:

"Subject to the provisions of this section, the dismissal of an employee shall be deemed, for the purposes of this Act, to be an unfair dismissal unless, having regard to all the circumstances, there were substantial grounds justifying the dismissal."

 Section 6(4) of the Act provides:

"Without prejudice to the generality of subsection (1) of this section, the dismissal of an employee shall be deemed, for the purposes of this Act, not to be an unfair dismissal, if it results wholly or mainly from one or more of the following: …

(b) the conduct of the employee…"

 Section 6(7) of the Act provides:

"Without prejudice to the generality of subsection (1) of this section, in determining if a dismissal is an unfair dismissal, regard may be had, if the adjudication officer or the Labour Court, as the case may be, considers it appropriate to do so -

(a) to the reasonableness or otherwise of the conduct (whether by act or omission) of the employer in relation to the dismissal, and

(b) to the extent (if any) of the compliance or failure to comply by the employer, in relation to the employee, with the procedure referred to in section 14(1) of this Act or with the provisions of any code of practice referred to in paragraph (d) (inserted by the Unfair Dismissals (Amendment) Act 1993) of section 7(2) of this Act."

Gross Misconduct:

The Respondent submits that the Complainant's clear failure to comply with the SOP, as established by the Respondent through its own internal checks, and as admitted by the Complainant during the investigation meeting, represents an act of gross misconduct within the meaning of the Respondent's disciplinary policy, and that the dismissal of the Complainant was reasonable and proportionate in the circumstances.

 Whereas the Complainant characterises the incident as human error and submits that it should have been treated as a more minor offence, The Respondent contends that this entirely misrepresents the seriousness of the misconduct in question.

The Respondent operates in a strictly regulated environment and must ensure that all of its employees and agents comply with all relevant procedures, including but not limited to the SOP. Furthermore, the Respondent submits that the Complainant's characterisation of the incident as a minor error is not tenable or credible in the context of the Complainant's 20 years' experience in the field of microbiology.  

 In DHL Express (Ireland) Ltd. v Michael Coughlan UDD1783, the Labour Court noted that an employer must clear a high bar in order to establish that an employee's behaviour can be legitimately described as gross misconduct. The Labour Court cited an earlier decision of the EAT in which it was stated that gross misconduct “applies only to cases of very bad behaviour of such a kind that no reasonable employer could be expected to tolerate the continuance of the relationship for a minute longer”.

The Respondent submits that, when looked at in the context of the Respondent's regulatory environment and the incredibly serious consequences of a breach of the SOP, the conduct of the Complainant could reasonably be regarded as gross misconduct and something that an employer in the same industry would not tolerate.  The Respondent submits that whereas, on the face of it, the description of the Complainant's conduct may appear to those unaccustomed to the industry to be an innocent mistake, the reality is that, had an inspection been carried out by a regulatory agency on the day in question, this would have been treated as an extremely serious issue, and may have jeopardised the Respondent's entire business.

The Respondent argues that evidence of the genuineness of the Respondent's response to such an incident can be found in how the Respondent initially reacted upon discovery of the unchecked plates. Having verified that these samples were linked to the Complainant, the Respondent immediately suspended him on full pay in order to carry out an investigation. The Respondent's disciplinary policy provides that "only in extreme circumstances… will the [Respondent] suspend an employee from work."  

Reasonableness of the Dismissal

The Respondent cites O’Riordan v Great Southern Hotels UD1469/2003, the Employment Appeals Tribunal outlined the following guiding principles which should be adhered to by an Adjudication Officer when considering whether or not the Respondent reasonably concluded the Complainant was guilty of an act of gross misconduct:

“In cases of gross misconduct, the function of the Tribunal is not to determine the innocence or guilt of the person accused of wrongdoing. The test for the Tribunal in such cases is whether the respondent had a genuine belief based on reasonable grounds arising from a fair investigation that the employee was guilty of the alleged wrongdoing”.

 The Respondent contends that the reasoning has been echoed further by the High Court in Governor and Company of the Bank of Ireland v James Reilly [2015] IEHC 241, in which Noonan J remarked:

"Section 6(7) makes clear that the court may have regard to the reasonableness of the employer's conduct in relation to the dismissal. That is however not to say that the court or other relevant body may substitute its own judgment as to whether the dismissal was reasonable for that of the employer. The question rather is whether the decision to dismiss is within the range of reasonable responses of a reasonable employer to the conduct concerned."

 The Respondent cites  Christopher Reddin v Irish Aviation Authority UD/16/127,  where the Labour Court addressed the question of whether a breach of a policy which is designed to ensure health and safety of others (in this case, a substance abuse policy) could constitute gross misconduct, and whether dismissal by the employer was reasonable:

"The court is satisfied that the respondent had in place a best practice approach to alcohol and drug dependency which was based on international best practice. It is the responsibility of the respondent to ensure that risks to others are identified and controlled while employees have a responsibility to take reasonable care to ensure the health and safety of themselves and others who may be affected by their acts or omissions. …

Having regard to the respondent's policy which clearly states that attending the workplace while under the influence of drugs and/or alcohol is gross misconduct subject to a sanction of summary dismissal, the court is of the view that it was reasonable in the circumstances to dismiss the complainant when he presented for work substantially over the alcohol limit on 31 July 2015."

The Respondent submits It is well established that employers are entitled to operate a zero-tolerance policy in respect of certain instances of gross misconduct. This is evidenced by the decision of the Employment Appeals Tribunal in Byrne v Marks & Spencer (Ireland) Limited UD826/2013, in which the dismissal of an employee was upheld in circumstances where the employee consumed a drink without paying for it.

The Respondent refers to Agnes Maranan v Beechfield Nursing Homes Limited UD961/2015, where the Employment Appeals Tribunal upheld the dismissal of a healthcare worker who had breached a patient dignity policy. In that case, the employee accepted responsibility, but sought to argue that a zero-tolerance treatment of the misconduct was unfair. The EAT noted the employee's underestimation of the incident, but due to the fact that this was stated to be gross misconduct in the employer's policy, and due to the seriousness of the misconduct, it was reasonable for the employee to be dismissed.

The Respondent denies the accusation by the Complainant that his dismissal amounts to the Respondent making an example of him.  The Respondent refers to the fact that in the last two to three years alone, the Respondent has dismissed three employees for gross misconduct in circumstances where the employees in question failed to record scientific data to the cGMP standards in a similar manner to the Complainant's misconduct.

Irreparable Damage to Trust and Confidence:

 On this point the Respondent cites  Shane Connolly v Tesco Ireland UD1394/2011, where  the Employment Appeals Tribunal held:

"In the context of the Complainant's misconduct, the Tribunal is satisfied that the sanction of dismissal was not a disproportionate one. An employer is entitled to repose trust in his employees ... The Complainant by his misconduct has broken that trust."

The Respondent submits that the seriousness of the Complainant's conduct cannot be overstated, nor can the damaging effect this has had on the Respondent's trust and confidence in the Complainant's ability. The Respondent contends that to protect its reputation both from a client and regulatory perspective, it was necessary and proportionate to adopt the position that it could no longer have faith that the Complainant was capable of handling such critical work going forward.

 The Respondent's disciplinary policy notes that "gross misconduct is misconduct serious enough to destroy the employment contract and make any further working relationship and trust between the Company and the employee impossible.". Accordingly, the Respondent submits that it acted reasonably in considering that its trust and confidence in the Complainant had been irreparably damaged by his actions.

Procedurally Fair Dismissal.

 The Complainant at all times was afforded a robust and fair investigative and disciplinary process in accordance with the Respondent's disciplinary policy. Accordingly, the decision by the Respondent to dismiss the employee for gross misconduct was procedurally fair having regard to the Complainant's right to natural justice and fair procedures.

Conclusion.

 The Respondent contends that the Complainant engaged in conduct which breached the Respondent’s SOP and was contrary to the stringent international standards under which the Respondent was obliged to operate in order to ensure that drug products are of sufficient quality for their intended use. The Respondent considered that dismissal was the appropriate sanction and one which was proportionate, and fair given the seriousness of the conduct. The Respondent argues that a lesser remedy was not appropriate given the fundamental breach of trust and confidence between the parties resulting from the Complainant’s conduct. The Respondent asserts that the Complainant was afforded an independent appeal process arising from which the decision to dismiss was upheld.

On Wednesday 4 November 2020  the Complainant was assigned to reading water samples in a process with the Respondent known as ML1. An earlier stage of this process is where water, to be used in the manufacture of medicine, is put through a filter on to the plates. The plates are then incubated for 5-7 days to see if bacteria are present. Control samples, which do not have bacteria, are also put into the incubator to make sure the test is valid. The bacteria can be seen by the naked eye if it is present in the plate. The fact of whether the plate contains bacteria or not is then inputted into a computer using ‘Smartlab’ software. A crucial difference between ML1 and ML2, in which the Complainant had been trained, is that the microbiological plates are tagged differently in ML2 readings, in that the number of plates is inputted on the tag. In ML1 the number of plates present does not make it on to the tag.

It is the Complainant’s contention that he was trained to put the microbiological plates all together in the incubator. On the day in question, the microbiological plates were separated. There were twelve at the front of the incubator, two of which were control samples. There was a further twenty in the incubator, which at the time he was retrieving the front twelve, the claimant could not see.  He proceeded to read the twelve plates, all of which contained no bacteria. He thought that was all there was. He was mistaken. The Standard Operating Procedure (SOP) requires the Analyst, prior to reading for bacteria, to 'reconcile' the plates in the testing session versus the physical plates and ensure all samples are accounted for. This means that as each sample has an individual number on the computer, one can determine, or reconcile, that the number of samples on screen matches the number of plates physically before the Analyst.

While the Complainant would normally do the reconciliation process, on this occasion, he did not. Having read the plates and found no bacteria he disposed of same. He then inputted a ‘zero’, indicating no bacteria present, into each of the 30 boxes that appeared on screen. Due to distraction, he forgot how many samples he had read, and as the screen had tabs for 5 or so boxes into each of which the Complainant was inputting a ‘zero’, he absentmindedly filled them in, not noticing that the number of boxes he was filling in was more than he had read.

In the shift which followed, a co-worker found the 20 plates which the Complainant had missed, and same were tested. As a result, the Complainant was immediately suspended.

Investigative and Disciplinary Process.

The Complainant was written to by the Respondent asking him to attend a Disciplinary Investigation Meeting on 11 November 2020. The Complainant was not informed in that letter that a potential ultimate outcome of the meeting could be dismissal. The Complainant attended one meeting on 11 November 2020 with the HR Manager and the Director of Irish and UK operations (hereinafter ‘the Director’). The HR manager   opened the meeting confirming that it was being held under the Disciplinary Investigation Policy as a result of an alleged act of Gross Misconduct in relation to a plate reading at the client site. The HR manager (having already done so by letter) advised the Complainant of his right to representation and whether he wanted more time to organise a colleague to accompany him. The Complainant declined.  

The HR Manager advised the Complainant that this was a serious incident which could result in disciplinary sanction up to and including dismissal. This was the first time that the Claimant was aware that he could be dismissed for his mistake.

At the meeting the Complainant outlined what happened on the day. He said he opened the ‘Smartlab’ session, removed the plates from the incubator and checked each sample and entered the results. He observed that usually all plates within a sample are stored together in the incubator but in this case, they weren't. The Complainant could only read ten samples as his view of the other 20 were obscured.

The Complainant stated that the sample tags in ML1 don't indicate the number of plates in each group. This is standard practice in ML2. It was noted that there was room for improvement in this procedure. The Claimant attributed the lack of numbering on the tagging as a contributing factor but acknowledged that there was an error on his part, and he accepted responsibility.

The HR Manager asked the Complainant to outline the procedure for examining the samples. The Complainant described the reading procedure as to check each plate for growth. Plates with growths are put to one side for recording, and the blank plates are entered as zero for each sample. The Director asked the Complainant whether he routinely had the reading procedure open in front of him. The Complainant said he did not. The Director stated that the procedure was very clear. Plates should be read individually, and each result recorded as it is read. He said that part of the procedure was to reconcile plates, having removed them from the incubator, and prior to reading the plates. The Complainant once again accepted the error on his part. In mitigation for this, the Complainant said that he would usually reconcile the number of plates versus the number in the sample, however, he was so busy on this day he did not do it. He thought the shelf was empty at the time of reading. The plates are usually stored together but, in this case, they weren't. He stated that the tag should state the number of samples, similar to the procedure in ML2. Prior to this incident he had a strong year as an employee. He received very good feedback from management on his performance.

The Complainant was written to on the 17 November 2020.  In that letter the HR Manager outlined once more that the Claimant had been suspended on the basis that the Complainant had engaged in gross misconduct and that it was misconduct serious enough to destroy the employment contract and to make any further working relationship and trust between the company and the employee impossible. It was further outlined in the letter that by not following the reading procedure, which required the operator to read each plate and record each plate individually, coupled with not reconciling plates once they were removed from the incubator prior to reading, he had committed a very serious breach of cGMP requirements. This raised data integrity concerns, which had resulted in a complete breakdown in trust. The HR Manager went on to confirm to the Complainant, the decision to summarily dismiss him from his position of PSS Analyst: Level 3 with immediate effect. He was informed of his right to appeal.

The appeal was conducted by two Senior managers in HR and Administration. There was no further hearing. It was a paper appeal. The Complainant was written to by the one of the managers on 24 November 2020. She outlined his grounds of appeal and the finding on those grounds. 

The first ground was related to the shortcomings in the ML1 procedure itself, in that the number of samples per batch in ML1 are not listed on the tag, as is the case in ML2. Having considered his submission, it was acknowledged that this could be introduced as an improvement to the procedure, however, that was not a valid reason for not following the Standard Operating Procedure.

The second ground of appeal for the Complainant was that this was his first 'offence'. The manager noted that during the first investigation the Complainant had confirmed that he routinely did not have the Standard Operating Procedure in front of him while reading and recording data, as was required. She found therefore, that this was not the first time that he had not followed procedure. On this point the Complainant asserts that this is a circular argument. While not having the Standard Operating Procedure in front of him while reading and recording data is in itself a technical breach of said same Standard Operating Procedure, it does not go to show he failed on other occasions to follow that Standard Operating Procedure, whether it was in front of him or not. The Complainant stated at the investigative hearing that he would always reconcile the plates. Further, in no company document is not having the Standard Operating Procedure in front of an analyst, who is reading and recording data, deemed gross misconduct.

The third ground of appeal was that all analysts have incidents of human error. While acknowledging that human error does occur, the appeal adjudicators went on to say they considered it a very serious issue to not follow a Standard Operating Procedure. They found that a heavy emphasis was placed on data integrity, GDP and GMP in both training and day to day operations. They determined the issue could not be attributed to human error, rather a failure to follow well documented and known procedures. They relayed the manner in which SOP KIN-41724 described clearly and in a simple way the process for reading microbiological test plates. There was no ambiguity with the procedure that could contribute to the correct recording of result. The Complainant argues that this conclusion has the effect of somewhat misunderstanding human error. The Complainant, at all stages was open and honest with the Respondent. He acknowledged that not reconciling the plates, prior to reading, was not following Standard Operating Procedure and that was a mistake on his part. He submits that other employees have made mistakes by not following Standard Operating Procedure and have not even been sanctioned, let alone being actually dismissed.

The final ground of appeal was that the Complainant felt he was being made an example of. This was dismissed.

The letter was ended by informing the Complainant that the Disciplinary Policy, provided to him at the commencement of employment was very clear, that failure to record scientific data to cGMP Standards was considered to be an act of gross misconduct.

No Contractual List of Incidences of Gross Misconduct.

The Complainant submits that he was not given a list of examples of what might constitute gross misconduct when he received his initial contract of employment. The Disciplinary Procedureas given to the Claimant when he commenced employment defined acts of Gross Misconduct thus:

"An act of gross misconduct is unacceptable behaviour of such seriousness on the part of an employee, that it warrants dismissal regardless of the previous disciplinary record of the individual."

The next page of The Disciplinary Procedure goes on to state that 'the following list (which is not exhaustive) constitute acts of gross misconduct. Thereafter, no such list was enumerated.

Summary of Complainant’s Evidence:

The Complainant had 18 years combined experience as an analyst in three different companies. A few weeks before the incident in question, the Complainant had received a ‘Superlative’ award from the Respondent.

He believes there was an element of inexperience in his actions on the day due to a different tagging system which was applied in the ML1 system compared to the ML2 system where the tags do not record the number of samples to be taken. He did not see all the tags, there were only 5 on the screen. He does not accept that he fabricated data but instead made an error when inputting data. He accepts that it was a major mistake but felt he was distracted due to the fact that he was overly busy on the day. 

The Complainant asserts that he did not find out that the question of data integrity was listed as gross misconduct until being told, after the incident had taken place. He said that an ‘entry error’ was a very common GMP error. He never saw an analyst with the SOP instructions opened. He knows of one analyst who mixed up the sample reading on plates and inputted a Sample A reading when it should have been a Sample B reading and this person was not fired.

Cross-Examination:

He accepted that data integrity is critical given the nature of the Respondent’s business. He acknowledged that if the data is incorrect then there is no point in having data compiled. He said that his mistake was always going to be spotted.

Summary of Ex-Employees evidence:

The witness described himself as an ex-employee of the Respondent who had been employed with the Respondent as a microbiology lab analyst from March 2018 to August 2021. He was familiar with the ML1 and ML2 processes. He said that some employees did not always have the SOP instructions opened but that there were some instances where it was necessary to open them. He knew of one instance where an error was made with regard to the inputting of data into an incorrect column but that the person was not dismissed. He had also made an error in that he had miscounted a plate by not noticing a colony of bacteria on it. This error was discovered on a quality inspection. He had no experience of hearing about, or observing, the input of false data.

Legal Arguments

The Seriousness of the Conduct

The Complainant cites  Brennan v Institute a/Technology Carlow [2012] E.L.R. 49 where the Gross Misconduct must be very serious indeed, "perhaps criminal or quasi-criminal in nature" .1.  The Complainant submits that the company  have determined  that failure to record scientific data to cGmp standards is gross misconduct, the Complainant contends   that such a stance is utterly disproportionate to many individual cases, taking into account how the failure occurred, what the employee's mens rea (as it were) was at the time, what the consequence was for the company, the attitude of the employee to the incident and  the employee's work record with the company.

The Complainant acknowledged his mistake from the outset. He acknowledged that he failed to reconcile the plates and that this, and other factors led him to make the mistake. It was a mistake that he was very unlikely to ever make again, given what he went through with the disciplinary process. He was under pressure at the time. He absentmindedly did what he did. It was an isolated incident. The mistake was picked up upon and fortunately no dire consequences occurred for the company or anyone else. The Complainant had an exemplary work record and had been highly regarded for his work.

Notice of Definition of Misconduct:

The Complainant cites Heffernan v Dunnes Stores [2011]  E.L.R. 202to show the onus is on the employer to update and remind employees of what is expected of them at staff meetings, through circulars, through notifications on staff noticeboards. Considering the seriousness for employees that failure to record scientific date to cGMP standards, no matter what the reason, and even if it is an isolated incident, is deemed gross misconduct and will result in dismissal, there should be no question that it be brought to the attention of everyone affected. The Complainant states that he did not see the Disciplinary Procedure that made this so until the investigative process was under way. That is a serious breach of fair procedures.

Proportionality:

The Complainant cites Bigaignon v Powerteam Electrical Services Ltd {2012} E.L.R. 195 to show that a dismissal must fall within what are recognised as proportionate responses. Other Analysts with the company have failed to record scientific data to cGMP standards, which has not led to their dismissal or indeed any sanction at all. The Complainant submits that to deem any failure to record scientific data to cGmp standards without considering individual circumstances is wholly disproportionate. Most of the items on the gross misconduct list require intention or the employee wilfully doing something. The Complainant submits that this is not the case here and dismissing an employee for this type of mistake falls outside what could be deemed a reasonable range of responses.  

I have carefully considered the evidence and legal argument over the three days of hearings. The respondent has taken the very firm line that the falsification of data contrary to cGMP amounts to gross misconduct and therefore must result in a termination of employment. The Complainant asserted that he put his hand up immediately for a breach of procedures but that his conduct was inadvertence as distinct from wilful intention and that therefore the decision to dismiss was outside the band of reasonable responses that a reasonable employer would adopt.   

In forming any decision, I must consider the reasonableness of both parties' conduct, actions and decisions. Both parties agreed that the relevant incident of non-reconciliation of samples had taken place on 4 November 2020. The Complainant did not raise any significant procedural issue with regard to the dismissal. A pivotal issue to be decided is whether the behaviour complained of was gross misconduct or simply misconduct. It is therefore necessary to examine the incident itself as well as factual background against which the conduct in issue arose.

Section 6 of the Unfair Dismissals Act 1977, as amended, (the Act) states, in relevant part, as follows:

6.—(1) Subject to the provisions of this section, the dismissal of an employee shall be deemed, for the purposes of this Act, to be an unfair dismissal unless, having regard to all the circumstances, there were substantial grounds justifying the dismissal… (4) Without prejudice to the generality of subsection (1) of this section, the dismissal of an employee shall be deemed, for the purposes of this Act, not to be an unfair dismissal, if it results wholly or mainly from one or more of the following:

(a) the capability, competence or qualifications of the employee for performing work of the kind which he was employed by the employer to do, (b) the conduct of the employee, (c) the redundancy of the employee, and (d) the employee being unable to work or continue to work in the position which he held without contravention (by him or by his employer) of a duty or restriction imposed by or under any statute or instrument made under statute.

 Employers must act reasonably in taking a decision to dismiss an employee. Section 6(7) of the Acts provides:

“(7) Without prejudice to the generality of subsection (1) of this section, in determining if a dismissal is an unfair dismissal, regard may be had, if the adjudication officer or the Labour Court, as the case may be, considers it appropriate to do so—

(a) to the reasonableness or otherwise of the conduct (whether by act or omission) of the employer in relation to the dismissal, …

The band of reasonable responses test was considered by the Irish High Court in Bank of Ireland v Reilly [2015] IEHC 241.   In that case Noonan J. highlighted that s.6(7) of the Unfair Dismissals Act 1977 provides that a court may have regard to the reasonableness of the employer's conduct in relation to a dismissal, and stated:

“That is however not to say that the court or other relevant body may substitute its own judgment as to whether the dismissal was reasonable for that of the employer. The question rather is whether the decision to dismiss is within the range of reasonable responses of a reasonable employer to the conduct concerned”.

My task is not to consider what sanctions I might impose if I were in the shoes of the Respondent but rather whether the reaction of the Respondent and the sanction imposed lay within the range of reasonable responses. The proportionality of the response is key and that even where proper procedures are followed in effecting a dismissal, if the sanction is disproportionate, the dismissal will be rendered unfair.

The Complainant gave evidence that he did not realise that not abiding by cGMP amounted to gross misconduct until he was informed during the investigatory/disciplinary process. The Respondent exhibited induction presentation slides for new employees which stated in its relevant part under ‘Ethics’: “The wilful falsification of records or intentionally giving false data in information to anyone who is responsible for keeping such data is considered an act of gross misconduct and will result in dismissal.” Extensive convincing evidence was given by the Respondent witnesses of the necessity for complete confidence in the data submitted by analysts when checking the purity of water for a client pharmaceutical site. In cross-examination the Complainant acknowledged the critical importance of correct data in the analytical process. I cannot accept the argument that he was not aware that such conduct constituted gross misconduct in light of his 18 years’ experience in the role.

The Complainant and the ex-employee both gave convincing evidence that employees did not have the SOP opened when working and that employees made mistakes but were not punished by dismissal. The Respondent gave evidence of three employees who were dismissed for falsification of data. A critical question regarding the incident of non-reconciliation of all the plate samples was whether the Complainant committed an excusable error, or did he intentionally enter false data. (If it was Inadvertence on behalf of the Complainant, then it is merely misconduct which deserves a reprimand short of dismissal whereas if he had a blameworthy state of mind then his actions on the day would be reasonably classed as gross misconduct). The Director of Operations acknowledged in his evidence that he did not believe that the conduct of the Complainant on the day was wilful in that he did not set out to do such a thing. I concur with that viewpoint. However, I conclude from the evidence that the Complainant was aware of his mistake in not having a full reconciliation of samples but nevertheless continued with the deliberate act of inputting incorrect data for samples that were not examined. This deliberate act brings the Complainant’s action on the day in question out of the realm of inadvertence and within the scope of gross misconduct. Furthermore, the gravity of such misconduct has to be measured in the context of the crucial responsibility the Complainant had in ensuring that the data on the analysis of the supply of clean water for the manufacture of human pharmaceuticals, was correct.  

After hearing the totality of the evidence, I find that the actions of the Complainant on the day in question amounted to gross misconduct and that the sanction of dismissal for gross misconduct was proportionate having regard to all the circumstances. I find the Complainant was not unfairly dismissed.

CA-00041663-001: After hearing the totality of the evidence I find that the actions of the Complainant on the day in question amounted to gross misconduct and that the sanction of dismissal for gross misconduct was proportionate having regard to all the circumstances. I find the Complainant was not unfairly dismissed.

Unfair Dismissals Act 1977, Proportionality, Gross Misconduct