Why Quality Audit implies lot of paper printing?
The question has crossed my mind number of times during my 25 years of working with small and multinational organizations. I could not come to term with the most sacred practice of audit exercise after every 6 months or 12 months, I am calling it sacred as this is how it is felt and taken by almost all the organizations servicing customers (especially IT companies). Initially (at the start of my career), I was of the view that probably this practice, associated way to comply with it and subsequent euphoria after getting successful (or unscathed) from the exercise is unique to software industry but no I was not right, it is impacting all industries (be it manufacturing or regulatory or service). The practice is followed religiously in manufacturing (adhering to various NORMS of ISI, BIS, hallmark or ISO etc) and many regulated industry (such as Calibration and Material testing governed by NABL ISO 17025 rules and guidelines).
The QA audit is one of the most feared but at the same time most sought in the organizations. Irrespective of organization or its size, few things that is common to QA audits.
- Printer become most essential hardware in the month preceding Audit date
- Paper become most sought commodity in the period prior to Audit
- All the accessories related to Papers (such as file cover, printer ink, stapler, punching machine and not to forget paper trashing machine)
The question intrigued me more as I belong to IT industry that proudly offered automation of offices and also making tall claims of making paperless office. But when it comes to our own operations, we are so heavily dependent on paper evidences. There are some common beliefs underlying the importance of paper which need to be discussed.
- Auditors like paper based evidence
- In case, Auditors ask for follow-up evidence, sometime could be wasted searching for follow-up evidence (we all know that Auditor has to finish his job in limited timeframe)
- Paper trails are more finite and robust compared to digital data.
- The papers that are not to be exhibited can be hidden back under the table or trunk, the same cannot be done easily with IT application
Well, if in case your organization is sincerely seeking quality improvements then start with making paperless office, any quality certification (be it SEI CMM or ISO or any other) gives high importance to the toolsets especially those using technological implementation of processes.
From an auditor perspective, automation of process is definitely better then paper based trail as software are bound to be rule and logic based, if logic and rules are correct then there is little time to be wasted on seeing details. It makes their job much easier as follow-up evidences are there just a few clicks away.
Then next question is, how to waste time as if follow-up actions are just a click away, it would mean auditor would review more number of projects and departments thus probability of messy project getting audited increase and thus the chances of getting pass through audit. Well, as a technician I know technology also provides many means to waste time, I am not going in details of that but just be cautious, you may get away from messy projects by adopting some but auditor may investigate those reasons then and you may find your organization in greater mess.
The change is blowing in one way only, industry have realized futility of paper and have started printing “go green” underneath all their communications (email or letterhead), have started reducing paper usage and thus paper wastage. Auditors have become more open, younger and more computer savvy (unlike old grey haired men of the earlier era). Paper cost have been increasing since many years and it is one of the avoidable expense.
SCC introduced software for calibration and testing laboratories (LIMS), business of these laboratories are highly paper intensive and laboratories are not only required to record evidences at each step in the process but also required to keep these records for at least two years. With the SCC LIMS, all the steps in the processes are automated by the application and all the steps are digitally stored in database for retrieval later. All calibration observation data and test result data could be entered directly in application with the flexibility of converting these data into readable file format. All the documents received from the customer or generated by the application are stored in readable document format thus providing greater control and flexibility to retrieve the documents at later date.
Satvinder is certified internal auditor and have faced more than a decade of audit exercises during his service in IT organization while have conducted internal audit of many projects within office. He has lead Software engineering process group and introduced many metrics and practices in his area of influence in that capacity and also as consultant to other organizations.
SCC has a mission to make organizations paperless, thus have started its journey with the most regulated industry of calibration and material testing where the industry has to comply with stringent ISO,NABL rules and guidance. SmartCalibration for Calibration and SmartLIMS for testing laboratory was designed with the theme of making laboratory processes paperless.
